SecondLook Digital for Fuji Labeling and User Manual
Contents
1. at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist would determine if any additional work up was required If there were no CAD marks no re evaluation of the mammograms would be necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist The third page then presents a summary of the case which includes the case history the mammographic findings and the resulting pathology An arrow points to the location of the tumor in printed versions of the mammograms DTM042 iCAD Inc Page 22 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E 4 2 Sample Cases 4 2 1 Case 1 Case History and Mammograms Case 1 History 62 yo female with palpable mass in upper outer quadrant of right breast No family history of breast cancer ses DURING CLINICAL USE THE INITIAL MAMMOGRAPHY REVIEW AND e INITIAL WORK UP DECISION WOULD BE ACCOMPLISHED cs DTM042 iCAD Inc Page 23 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Mammograms with CAD Marks Case 1 Note The softcopy review workstation may use symbols other than rectangles calcifications and ellipses masses for the CAD marks ses DURING CLINICAL USE THE AREAS OF CONCERN HIGHLIGHTED BY TT THE CAD MARKS WOULD BE RE EVALUATED USIN2. i E Never stop looking SecondLook Digital for Fuji Labeling and User Manual 2009 iCAD Inc All Rights Reserved iCAD the iCAD logo Never Stop Looking and SecondLook are registered trademarks of iCAD Inc Other company product and service names may be trademarks or service marks of others DTM042 Rev E SecondLook Digital for Fuji Labeling and User Manual Rev E This page intentionally left blank DTM042 iCAD Inc Page 2 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E CAD Never stop looking 98 Spit Brook Rd Suite 100 Nashua NH 03062 USA 603 882 5200 The European Representative for iCAD Inc is MDSS GmbH Schiffgraben 41 30175 Hannover Germany DTM042 iCAD Inc Page 3 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E This page intentionally left blank DTM042 iCAD Inc Page 4 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 3 1 3 2 4 1 4 2 4 2 1 DTM042 VS da duns nee vaek EENS ENEE EE awaa Ka aeaa ankaa a UKWA SEAN 7 E 7 INDICATIONS FOR RE 7 BRIEF DEVICE D scChpmoN AE ESNEA ESSEEN EASE EN ESEAS EAE En EEEE Earra en nren 7 KT 8 PRECAUTIONS 2 scetgen cae ariin eed dan daa etic sat denen ough edd di See hdd dee ean oh ah dan aaa aa aa ee 10 ADVERSE EE 10 CLINICAL DTUDIES 10 DETAILED DEVICE DESCRIPTION Eeer 16 CONFORMANCE TO BTANDARDS tekt tttt ttt
3. cases percentage 7 19 Number of BI RADS breast density 4 cases percentage 6 17 Table 3 Fuji CRm Database Demographics Non Cancers All Cases DESCRIPTION ALL CASES Number of Cases 155 23 Number of BI RADS breast density 1 cases percentage 6 6 5 42 ee ee e This dataset does not include cases with global asymmetry SecondLook Standalone Testing with Fuji CRm Images Standalone testing of the SecondLook version 6 0 with Fuji CRm images provides a performance measure i e sensitivity and average number of false positives per image or case in the absence of any interaction with a radiologist Standalone performance measures how often the CAD device places prompts over regions that contain or do not contain known breast abnormalities i e microcalcifications and or masses in the absence of radiologist interaction Sensitivity Analysis DTM042 iCAD Inc Page 12 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E SecondLook version 6 0 with Fuji CRm images sensitivity was estimated using manual scoring performed by a radiologist who satisfied the Mammography Quality Standards Act MQSA requirements The radiologist performed this subjective scoring using imagery pertinent data from the mammography and pathology reports and the CAD marks A CAD mark was assessed as a true positive detection by subjective scoring using imagery pertinent data from the mammography and pathology r
4. designed nor intended to prompt to o interval change s between mammographic exams asymmetry between the left and right breast tubular density solitary dilated duct skin thickening or nipple retraction e ee be DTM042 iCAD Inc Page 8 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Warnings System Operation e Do not use The SecondLook System if you suspect any electrical component is defective or inoperable e Do not place liquids on or near SecondLook If a liquid is accidentally spilled on electrical components immediately turn off the computer which will automatically shut down the system to prevent any potential electrical shock Contact your authorized SecondLook service provider for further instructions e Ensure that the system is connected to a properly wired and grounded power receptacle e Ensure that the voltage and current requirements are within system specifications to avoid bodily injury from electrical shock or fire hazard Warnings Installation and Maintenance e Modem Warning The modem is to be used by service personnel only in case the system requires remote servicing e EMC Warning This SecondLook system has been tested and found to comply with IEC 60950 1 EN 55022 and EN 55024 This system generates uses and can radiate radio frequency energy and if not installed and used in accordance with our installation instructions may cause or be subject to harmful interference wit
5. product contains no independently user serviceable parts To prevent damage to the system do not attempt to install or repair the SecondLook system Only trained personnel are qualified to install or repair the system For service training contact iCAD Inc at 1 866 280 2239 e Disconnect power cord before moving or servicing 2 5 Adverse Effects Second Look may increase your false positive rates for both screening and diagnostic mammography Increased false positives may lead to unnecessary additional imaging radiation exposure biopsy patient anxiety etc 2 6 Clinical Studies Refer to the SecondLook Analog for further details regarding the testing studies used to support the safety and effectiveness of the original approval of the SecondLook analog device for use with digitized film screen mammograms Benchmark testing Benchmark testing consisted of a limited standalone analysis i e analysis of the device without radiologist interaction on a small sample of Fuji CRm mammograms 51 cancers 38 masses DTM042 iCAD Inc Page 10 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E including 3 architectural distortions and 1 focal asymmetric density and 13 clusters of microcalcifications Note that standalone performance testing of SecondLook version 6 0 on Fuji CRm images cannot be directly compared to standalone performance testing of SecondLook on digitized film screen images The benchmark testing did not
6. tett tt tt AStE ESEE ESNEESNEESSEENSEESSEES SEESE EN SESSE En nnen nn ennnen 20 HOW SUPPLIED EE 20 eelef gett 21 RADIOLOGIST REVIEW PRIOR TO VIEWING CAD MARKS ccs ceeeeceeeeeeeeeeaeeeeeeeceeeeeteaeeesnaeeneneeees 21 RADIOLOGIST REVIEW WITH CAD MARKS ccc ceceecceceeeeeceaeeeeeeeceeeecaeeesaeeeeaeeseeeeseaeeeseaeeneaeeees 21 EES 22 TRAINING INSTRUCTIONS s ssneskeeesst eetet tttttttttat tett attert Atta PE ESEESE ES EEEE ES NEA EASEEN ENEAS EENES EEEE EA NEEESE EEEE 22 SAMPLE CASES eben s d egen dien A d Age kee ia i delt A NE GA aAA aA E AARAA ENA 23 CaSO EE 23 Seeerei eege 26 weuwhdd aus nedwabchaaleauevga dssenapaewsce E EEN SEENEN ee leans 27 iCAD Inc Page 5 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E This page intentionally left blank DTM042 iCAD Inc Page 6 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E This manual describes the SecondLook Digital Computer Aided Detection CAD system and provides training to radiologists using the SecondLook Digital system for breast cancer detection e Section 2 provides SecondLook device labeling e Section 3 describes how a radiologist should use SecondLook Digital e Section 4 provides a sample case to familiarize the radiologist with SecondLook Digital e Section 5 provides a summary of the radiologist use of SecondLook Digital e Section 6 provides a list of clinical references 2 1 Indications for Use The S
7. this analysis all Fuji CRm images were assumed not to contain a mammographically visible cancer and therefore all CAD marks were considered false positive marks The false marker rate was calculated per case i e per patient and per image e per mammographic view separately Associated 95 Cl were estimated assuming an exponential distribution Per case false marker rate calculation is simply the total number of false positive marks for the case Per image false marker rate calculation is the total number of false positive marks divided by the total number of mammographic views The results for the false marker rate are summarized in Tables 6 and 7 Table 6 Case Based False Marker Rate Calculations for SecondLook Digital on Fuji CRm Digital Images Cases Enrolled Total 157 Contained Standard 4 Views All Non cancers 155 Contained Standard 4 Views BIRADS 1 Only 36 Scoring Results All Non cancer Cases Average CAD Marks per case 95 Confidence Interval 3 48 2 99 4 10 BIRADS 1 Only Cases Average CAD Marks per case 95 Confidence Interval 2 50 1 85 3 57 Table 7 Image Based False Marker Rate Calculations for SecondLook Digital on Fuji CRm Digital Images Images Enrolled Total 624 DTM042 iCAD Inc Page 15 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Contained Standard 4 Views All Non ca
8. 6 Dean JC Ilvento CC Improved cancer detection using computer aided detection with diagnostic and screening mammography prospective study of 104 cancers AJR 2006 187 20 28 DTM042 iCAD Inc Page 27 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E 17 18 19 20 21 22 23 24 25 26 27 Ko JM Nicholas MJ Mendel JB Slanetz PJ Prospective assessment of computer aided detection in interpretation of screening mammography AJR 2006 187 1483 1491 Fenton JJ Taplin SH Carney PA et al Influence of computer aided detection on performance of screening mammography NEJM 2007 356 1399 1409 Georgian Smith D Moore RH Halpern E et al Blinded comparison of computer aided detection with human second reading in screening mammography AJR 2007 189 1135 1141 Gromet M Comparison of computer aided detection to double reading of screening mammograms reivew of 231 221 mammograms AJR 2008 to appear in April issue Brem RF Baum J Lechner M et al Improvement in sensitivity of screening mammography with computer aided detection a multiinstitutional trial AJR 2003 181 687 693 Destounis SV DiNitto P Logan Young W et al Can computer aided detection with double reading of screening mammograms help decrease the false negative rate Initial experience Radiology 2004 232 578 584 Gilbert FJ Astley SM McGee MA et al Single Reading with Computer Aided Detection and Double Reading o
9. Digital CAD marks with the softcopy review workstation after determining whether or not a work up is indicated from her or his initial review of the patient mammograms The radiologist will take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist determines if any additional work up is required If there are no CAD marks no re evaluation of the mammograms is necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist Areas of concern marked by SecondLook Digital include suspicious clusters of microcalcifications spiculated and non spiculated masses architectural distortions and focal asymmetric densities Below is the recommended case review process with SecondLook Digital 1 Review patient history and evaluate Fuji CR mammograms prior to turning on and viewing CAD marks with softcopy review workstation 2 Make initial interpretation 3 Turn on and view CAD marks with softcopy review workstation and identify potential areas of concern 4 Review mammograms re evaluating areas of concern highlighted by CAD marks with softcopy review workstation 5 Render decision It is very important to remember that it is the radiologist who makes the final decision about a case When a radiologist decides to work up a case the CAD
10. G THE SOFTCOPY eee REVIEW WORKSTATION FROM THIS RE EVALUATION OF THE ante TT MAMMOGRAMS THE RADIOLOGIST MAKES THE FINAL WORK UP G TT DECISION GE DTM042 iCAD Inc Page 24 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Case Summary Case 1 History 62 yo female with palpable mass in upper outer quadrant of right breast No family history of breast cancer Mammographic findings 3 cm circumscribed mass with partially obscured borders in the right breast at 10 o clock shown to be a cyst on ultrasound Linear distribution of pleomorphic calcifications in the right breast at 2 o clock posteriorly Pathology Ductal carcinoma in situ arrows show location DTM042 iCAD Inc Page 25 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E The radiologist uses the SecondLook Digital CAD marks with mammography according to the following steps 1 2 3 The radiologist first reviews the Fuji CR mammograms without viewing the CAD marks following her or his existing procedures of clinical practice The radiologist will make an initial determination if a work up is indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation The radiologist turns on and views the CAD marks with the softcopy review workstation after determining whether or not a work up is indicated from her or his initial review of the patient mammograms The radio
11. ass P ZZ Figure 2 Densities Detected by SecondLook Further analysis of detected areas is accomplished by clustering individual microcalcifications and region growing densities Clusters include 3 or more individual microcalcifications that are each no more than 4 1 millimeters apart Figure 3 depicts portions of three different mammography images showing how the SecondLook system would highlight microcalcifications clusters in these examples These examples use CAD marks that are rectangular and correspond to the approximate size of the microcalcifications Region growing determines the shape of potential densities as shown in Figure 4 DTM042 iCAD Inc Page 18 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Figure 3 CalcMarks Highlighting Microcalcifications Clusters with a The minimum number of calcifications b The extent of the CalcMark enclosing all calcifications considered as part of the cluster c Overlapping CalcMarks are distinctly highlighted even when clusters are close to each other After clustering for microcalcifications analysis and region growing for density analysis clinically relevant and mathematical features are then computed to describe each detected cluster of microcalcifications and density For example the variability in size and shape of the calcifications in a cluster are good features to describe clusters of microcalcifications These features are used by microcalcif
12. econdLook Computer Aided Detection system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from Fujifilm Medical Systems Computed Radiography system Fuji CRm to bring them to the attention of the radiologist after an initial reading has been completed Thus the system prompts the radiologist to areas on Fuji CRm mammograms for second review only 2 2 Brief Device Description SecondLook is a mammographic computer aided detection CAD system that prompts radiologists to areas on Fuji CRM mammogram for a second review only The original CAD algorithm version 6 0 includes image processing feature computations and pattern recognition technology to detect regions of interest The algorithm was trained on digitized film screen mammograms and intended to more specifically identify potential breast lesions appearing as clusters of microcalcifications and or masses The CAD system was adapted to run on Fuji images but the CAD algorithm design remained unchanged and was not otherwise retrained on the Fuji CRm mammograms DTM042 iCAD Inc Page 7 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E For hardcopy reading the SecondLook output can be presented on a paper printout showing the CAD marks within the mammogram How to Use the CAD SecondLook with the Fuji CRm is intended to be used by a radiologist as follows The radiologist must always first perform a full conventio
13. eports and the CAD marks A CAD mark was assessed as a true positive detection by subjective visual assessment of whether the lesion overlaps at least 50 of the CAD mark Sensitivity is a count of the true positive detection divided by the total number of cases with mammographically visible cancer and was calculated separately on a per case i e per patient and per images i e mammographic view basis True positive detection was defined as follows For each scoring method if any lesion on an image was scored as a hit answered Yes then the image was scored as a true positive and the case was scored as a true positive Per case sensitivity was computed as the number of true positive cases divided by the total number of cases with mammographically visible cancer with 95 confidence intervals The 95 Cl were all computed assuming a normal distribution Per image sensitivity was computed as the number of true positive images divided by the total number of images with mammographically visible cancer with 95 Cl The 95 Cl were all computed assuming a normal distribution Results of the sensitivity analysis are summarized in Tables 4 and 5 Table 4 Case Based Sensitivity Results for SecondLook Digital on Fuji CRm Digital Images Total Cases Enrolled 53 Cases with Clearly Identifiable Lesion s 51 Predominant Type of Most Suspicious Lesion Cases with Masses 38 Cases with Microcalcifications 13 Scori
14. f Screening Mammograms in the United Kingdom National Breast Screening Program Radiology 241 pp 47 53 2006 Balleyguier C Kinkel K Fermanian J et al Computer aided detection CAD in mammography does it help the junior or the senior radiologist European Journal of Radiology 2005 54 90 96 Marx C Malich A Facius M et al Are unnecessary follow up procedures induced by computer aided diagnosis CAD in mammography Comparison of mammographic diagnosis with and without use of CAD European Journal of Radiology 2004 51 66 72 Hukkinen K Vehmas T Pamilo M Kivisaari L Effect of computer aided detection on mammographic performance experimental study on readers with different levels of experience Acta Radiologica 2006 47 257 263 Taplin SH Rutter CM Lehman CD Testing the effect of computer assisted detection on interpretive performance in screening mammography AJR 2006 187 1475 1482 DTM042 iCAD Inc Page 28 of 28
15. h other devices in the vicinity If the SecondLook system appears to cause or be subject to harmful interference try the following steps to correct the problem o Reorient or relocate the SecondLook system or the interface device o Increase the separation between the SecondLook system and the interfering device o Plug the SecondLook system into an outlet on a different circuit from the interfering device e Temperature and Humidity Warning SecondLook system operations must be performed within the following temperature and humidity ranges o Temperature 50 95 Fahrenheit 10 35 Celsius o Humidity 20 80 DTM042 iCAD Inc Page 9 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E 2 4 Precautions Precautions System Operation e To prevent damage to the system maintain equipment in a well ventilated air conditioned environment e Effectiveness and safety in patients with breast implants has not been established for views that include the implant When implant displaced views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient e Effectiveness and safety have not been established for non standard mammographic views e g magnification compression views When these views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient Precautions Installation and Maintenance e This
16. ications and density classifiers which are specifically designed to select the areas most likely to have features that may be seen with cancer Further analysis uses the context of all areas selected for the patient For example there is a maximum total number of SecondLook CAD marks each 4 image case can_ include Simultaneous analysis of all areas of concern detected in the patient allows the locations most likely to be cancer to be highlighted by the CAD marks DTM042 iCAD Inc Page 19 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Figure 4 Region Growing to Determine Shape of Density 2 8 Conformance to Standards Refer to the SecondLook Digital Service Manual for the CE Declaration of Conformity DTBO60 2 9 How Supplied The SecondLook system includes the following components e Uninterruptible Power Supply e Computer DTM042 iCAD Inc Page 20 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E 3 1 3 2 Radiologist Review Prior to Viewing CAD Marks The radiologist first reviews the Fuji CR mammograms without viewing the SecondLook Digital CAD marks following her or his existing procedures of clinical practice The radiologist will make an initial determination if a work up is indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation Radiologist Review with CAD Marks The radiologist turns on and views the SecondLook
17. ion Areas of Concern Highlighted by CAD Marks Figure 1 SecondLook CAD Algorithms Overview The CAD algorithms begin with image enhancement of the digitized mammographic images to accentuate all areas that could be individual microcalcifications and densities In the case of directly acquired images the digital images are first transformed into images that resemble digitized film in order to accommodate variations in inter pixel spacing gray level mapping and bit depth It should be noted that the Modulation Transfer Function MTF for Fuji images deviates from the MTF specified for SecondLook in the high frequency range While the MTF is not directly used in the calculations performed by SecondLook this deviation may impact the calculation of subtle features along the margins of lesions The microcalcification and density detectors then identify the areas that are most likely to be individual microcalcifications and densities based on an initial analysis of morphological and intensity measurements The types of densities detected are depicted in Figure 2 and include spiculated and non spiculated masses architectural distortions and focal densities DTM042 iCAD Inc Page 17 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Circumscribed Masses Round Oval Lobular Irregular Mass with Indistinct Margins S T wa Spiculated Mass Architectural Distortion Microlobulated Mass Obscured M
18. logist will take a SecondLook at the mammograms corresponding to any CAD marks From this re evaluation of the mammograms the radiologist determines if any additional work up is required If there are no CAD marks no re evaluation of the mammograms is necessary Work up decisions are not based solely upon the CAD marks All work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist DTM042 iCAD Inc Page 26 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E 1 Bird RE Wallace TW Yankaskas BC Analysis of Cancers Missed at Screening Mammography Radiology 184 pp 613 617 1992 2 Sickles EA Auditing Your Practice RSNA Categorical Course in Breast Imaging 1995 pp 81 91 3 Harvey JA Fajardo LL Innis CA Previous Mammograms in Patients with Impalpable Breast Carcinoma Retrospective vs Blinded Interpretation AJR 161 pp 1167 1172 1993 4 Martin JE Moskowitz M Milbrath JR Breast Cancer Missed by Mammography AJR 132 pp 737 739 1979 5 Schmidt RA Nishikawa RM Digital Screening Mammography PPO Updates 8 7 pp 1 16 1994 6 Thurfjell EL Lernevall KA Taube AAS Benefit of Independent Double Reading in a Population based Mammography Screening Program Radiology 191 pp 241 244 1994 7 Economic Impact Analysis of Regulations Under the Mammography Quality Standards Act of 1992 U S Food and D
19. marks must not change the decision however the CAD marks can identify locations for further work up that were initially undetected by the radiologist DTM042 iCAD Inc Page 21 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E 4 1 Training Instructions One sample case demonstrates the use of SecondLook Digital for the radiologist prior to clinical use This case is intended to familiarize the radiologist with the procedures for using the SecondLook Digital CAD marks The case review procedures are emphasized Therefore the training is accomplished by following the case presentation in Section 4 2 of this manual without requiring use of the softcopy review station For the example case in the manual the procedures for using SecondLook Digital CAD marks are demonstrated to the radiologist with the following steps 1 The first page will provide the case history and printed versions of the Fuji CR mammograms without CAD marks During clinical use the radiologist would first review the mammograms without viewing the CAD marks following her or his existing procedures of clinical practice The radiologist would make an initial determination if a work up were indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation The second page contains printed versions of the mammograms with CAD marks turned on During clinical use the radiologist would take a SecondLook
20. measure the effect of the device on radiologist performance and cannot measure or predict any change in radiologist s cancer detection rates when using the device as intended Fuji CRm Database Description Tables 1 3 provide the mammographic and pathologic characteristics on the Fuji CRm cases This database included 51 cases with cancer and 155 free of cancer Of the cancer cases there were 13 microcalcification cases 3 gt 2 0 cm and 34 mass cases 17 gt 2 0 cm 3 architectural distortion cases 1 gt 2 0cm and 1 focal asymmetric density case Table 1 Fuji CRm Database Demographics Cancers TOTAL NUMBER OF CANCER CASES Number of Primarily mass cases percentage 38 75 3 Number of Primarily microcalcification ycalc cases 13 25 percentage Mammography Mass Lesion size cm 1 9 1 32 9 Median 1 75 Range Minimum Maximum 0 5 7 5 Number of BI RADS breast density 1 cases percentage i Number of BI RADS breast density 2 cases percentage 24 45 S i 32 9 4 Number of BI RADS breast density 4 cases percentage Table 2 Fuji CRm Database Demographics Non Cancers BIRADS 1 Only DTM042 iCAD Inc Page 11 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E DESCRIPTION BI RADS 1 ONLY Number of Cases 36 Number of BI RADS breast density 1 cases percentage Number of BI RADS breast density 2 cases percentage 14 39 Number of BI RADS breast density 3
21. nal read of the mammogram and only after completing the conventional read the radiologist may choose to display the CAD marks which may prompt to areas that were or were not examined during the first read It is crucial to understand that 99 6 of all CAD marks will be placed over areas that are normal breast tissue or benign findings Be aware that the SecondLook is not a diagnostic device as the CAD marks are intended to be used to assist only in detection and not to assist with interpretation 2 3 Warnings Warnings Radiological Interpretation e The radiologist must always first perform a full conventional read of the mammogram and only after completing the conventional read the radiologist may choose to display the CAD marks which may prompt to areas that were or were not examined during the first read e The presence or absence of a CAD mark should not in any manner influence your diagnostic decision as to the nature of a mammographic finding i e normal vs benign vs malignant or the clinical action to be taken e g additional imaging or biopsy e Do not rely on the size or shape of the CAD mark as it may not be representative of the actual extent or shape of the breast lesion e Upon re evaluation for the original mammogram at the locations indicated by SecondLook the radiologist must use their interpretative skills to determine if the area should be worked up based on its mammographic appearance e SecondLook is neither
22. ncers 620 Contained Standard 4 Views BIRADS 1 Only 144 Scoring Results All Non cancer Cases Average CAD Marks per image 95 Confidence Interval 0 87 0 81 0 94 BIRADS 1 Only Cases Average CAD Marks per image 95 Confidence Interval 0 62 0 53 0 74 2 7 Detailed Device Description SecondLook uses computer aided detection CAD algorithms to identify regions of interest on mammograms that may contain suspicious finding The CAD algorithms use advanced image processing feature computations and pattern recognition technology to analyze the images for potential areas of concern These potential areas of concern are displayed for the radiologist by overlaying CAD marks at the appropriate locations of the mammography images within the softcopy review workstation or on a paper printout The CAD marks are used by the radiologist as an additional tool in breast cancer detection An overview of the SecondLook CAD algorithms is shown in Figure 1 DTM042 iCAD Inc Page 16 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Standard MicroCalc Density Algorithm Algorithm Calc Image Density Image Enhancement Enhancement MicroCalc Density Detector Detector 1 z Region Clustering Growing L L MicroCalc Density Classifier Classifier l Context Based Patient Evaluat
23. ng Results True Positive Cases With Masses Percentage Detected 95 Confidence Interval 87 76 98 With Microcalcifications DTM042 iCAD Inc Page 13 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E Percentage Detected 95 Confidence Interval 92 78 100 Overall Percentage Detected 95 Confidence Interval 88 79 97 Table 5 Image Based Sensitivity Results for SecondLook Digital on Fuji CRm Digital Images Total Images Enrolled 100 Images with Clearly Identifiable Lesion s 95 Predominant Type of Most Suspicious Lesion Images with Masses 71 Images with Microcalcifications 24 Scoring Results True Positive Images With Masses Percentage Detected 95 Confidence Interval 72 61 82 With Microcalcifications Percentage Detected 95 Confidence Interval 92 81 100 Overall Percentage Detected 95 Confidence Interval 77 68 85 False Marker Rate Analysis The false marker rate analysis of the SecondLook version 6 0 with Fuji CRm images was measured in two separate ways 1 Averaging the number of marks in all 4 views of BI RADS 1 cases and 2 By averaging the number of marks in all 4 views of cases without proven cancers BI RADS 2 5 DTM042 iCAD Inc Page 14 of 28 SecondLook Digital for Fuji Labeling and User Manual Rev E For
24. rug Administration and Eastern Research Group Inc Task Order No 1 Contract No 223 94 8031 October 7 1997 8 Quality Determinants of Mammography Clinical Practice Guideline Number 13 Agency for Health Care Policy and Research Publication No 95 0632 October 1994 9 Warren Burhenne LJ Wood SA D Orsi CJ et al Potential contribution of computer aided detection to the sensitivity of screening mammography Radiology 2000 215 554 562 10 Freer TW Ulissey MJ Screening mammography with computer aided detection prospective study of 12 860 patients in a community breast center Radiology 2001 220 781 786 11 Gur D Sumkin JH Rockette HE et al Changes in breast cancer detection and mammography recall rates after the introduction of a computer aided detection system JNCI 2004 96 3 185 190 12 Birdwell RL Bandodkar P Ikeda DM Computer aided detection with screening mammography in a university hospital setting Radiology 2005 236 451 457 13 Cupples TE Cunningham JE Reynolds JC Impact of computer aided detection in a regional screening mammography program AJR 2005 185 944 950 14 Khoo LAL Taylor P Given Wilson RM Computer aided detection in the United Kingdom National Breast Screening Programme prospective study Radiology 2005 237 444 449 15 Morton MJ Whaley DH Brandt KR et al Screening mammograms interpretation with computer aided detection prospective evaluation Radiology 2006 239 375 383 1
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