(50 days)
The Second Look® Viewer is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions-ofinterest or pre-computed CAD marks.
The Second Look® Viewer is composed of three primary components. The major component is the computer (1), which is supported by a touchscreen monitor (2) and a barcode reader (3). The computer is a conventional Intel based computer that is connected to the Second Look® CAD processing unit via a network. The Second Look Viewer serves no other purpose than viewer support. The physician interfaces to the software using the touch screen or barcode reader. The physician first barcodes a given patient whose mammography case has already been processed by the Second Look CAD processing unit. The viewer displays the Mammagraph™s with the pre-computed CAD marks overlayed. Second Look Viewer allows a radiologist to review Second Look® Analog CAD output, in softcopy format. The physician may touch any of the small images and see a higher resolution, magnified image along with characterization information for that image. After viewing the mammography case, the radiologist may use the Second Look® Viewer to review pre-computed ultrasound results, such as CADStream® output, if such results already exist for the case under review.
The provided text is a 510(k) summary for the Second Look® Viewer and related FDA correspondence. It describes the device, its intended use, and states that performance and validation testing indicate substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts, their qualifications, or adjudication methods for ground truth.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Details about the type of ground truth used (e.g., pathology, outcomes).
- Sample size for the training set or how ground truth was established for the training set.
The document states, "Results of performance and validation testing indicate that the Second Look® Viewer is substantially equivalent to the predicate device." This is a high-level conclusion required for 510(k) clearance, but the specific data and methodology of those tests are not included in this summary.
Therefore, given the provided text, I can only provide the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. The overarching acceptance criterion for 510(k) clearance is "substantial equivalence" to a predicate device for its intended use.
- Reported Device Performance: "Results of performance and validation testing indicate that the Second Look® Viewer is substantially equivalent to the predicate device." No specific performance metrics (e.g., sensitivity, specificity, accuracy, display quality, latency) are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not specified. The device is a "Viewer" for pre-computed CAD marks; it is not described as an AI algorithm itself for diagnosis or detection. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely to be directly relevant to the Viewer's specific function as described, though it would be relevant to the CAD system that generates the marks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a "Viewer," which by definition is a human-in-the-loop device (displaying information to a physician). It is not an algorithm that performs a diagnostic task independently.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not specified.
8. The sample size for the training set
- Not specified.
9. How the ground truth for the training set was established
- Not specified.
Conclusion from the provided text:
The provided 510(k) summary focuses on the administrative aspects of regulatory clearance based on substantial equivalence. It describes the device, its intended use (displaying low-resolution, non-diagnostic images with annotations/CAD marks), and states that performance and validation testing were conducted, the results of which supported the substantial equivalence claim. However, it does not disclose the detailed results, methodologies, sample sizes, or ground truth establishment processes from those underlying tests.
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510(k) Summary
NOV 1 9 2004
iCAD, Inc. Submitter: 2689 Commons Blvd., Suite 100 Beavercreek, OH 45431
John Rosenstengel Contact Person:
November 18, 2004 Date Prepared:
Device Trade Name: Second Look® Viewer
System, Image Processing, Radiological Common Name:
Classification Name: Picture archiving and communications system (21 CFR 892.2050)
Predicate Device(s): Consultiva™ Report Station (RS) by MiraMedica, Inc.
Device Description: The Second Look® Viewer is composed of three primary components. The major component is the computer (1), which is supported by a touchscreen monitor (2) and a barcode reader (3). The computer is a conventional Intel based computer that is connected to the Second Look® CAD processing unit via a network. The Second Look Viewer serves no other purpose than viewer support. The physician interfaces to the software using the touch screen or barcode reader. The physician first barcodes a given patient whose mammography case has already been processed by the Second Look CAD processing unit. The viewer displays the Mammagraph™s with the pre-computed CAD marks overlayed. Second Look Viewer allows a radiologist to review Second Look® Analog CAD output, in softcopy format. The physician may touch any of the small images and see a higher resolution, magnified image along with characterization information for that image. After viewing the mammography case, the radiologist may use the Second Look® Viewer to review pre-computed ultrasound results, such as CADStream® output, if such results already exist for the case under review.
Indication for Use: The Second Look® Viewer is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.
Technological Characteristics and Testing:
Conclusion:
Results of performance and validation testing indicate that the Second Look® Viewer is substantially equivalent to the predicate device
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing left, and the text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Mr. John E. Rosenstengel "Director. Quality & Regulatory Affairs ICAD, Inc. · 2689 Commons Blvd., Suite 100 BEAVERCREEK OH 45431
Re: K042697
Trade/Device Name: Second Look® Viewer Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: September 30, 2004 Received: September 30, 2004
· Dear Mr. Rosenstengel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Àct's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will and wyour your e FDA finding of substantial equivalence of your device to a legally premaince notification - wesults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dostre of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K042697
Device Name: Second Look® Viewer
Indications for Use:
The Second Look® Viewer is intended to be used to display low resolution, nondiagnostic medical images with annotations such as pre-computed regions-ofinterest or pre-computed CAD marks.
Prescription Use__X_ (Part 21 CFR 801 Subpart D) ANDYOR
Over-The-Counter Use_ (21 CFR 807 Part C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Legum
lominal, 510kl N
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).