CereMetrix Silver by CereMetrix Corp

The CereMetrix Silver software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical image modalities include SPECT, PET, MRI and CT as supported by ACR/NEMA DICOM 3.0. CereMetrix Silver assists in the following indications:

· Receive, transmit, store, retrieve, display, print, and process brain images and DICOM objects derived from radiological diagnostic systems, and processing workstations, among others.

· Create, display and print reports from medical images.

· Registration and review of brain images for diagnosis, treatment evaluation, and treatment planning.

· Localization and definition of objects and the differentiation between hyper or hypo perfused tissue, as compared to a composite average, in medical images.

· Creation of clusters for applications including quantitative analysis and archiving clusters for patient follow-up and management.

· CereMetrix Silver is capable of processing and displaying the brain image data in traditional formats, as well as pseudo three-dimensional renderings.

· CereMetrix Silver provides manual and automatic report creation plus the ability to view these reports remotely.

· CereMetrix Silver allows for quantitative and statistical analysis of SPECT brain scans by comparing to a composite average.

When used for diagnostic purposes, the mobile web client is not intended to replace a fill workstation and should only be used when there is no access to a workstation.

The software is not to be used for computer aided diagnostic purposes, including mammography CAD.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the CereMetrix Silver device, which is a Picture Archiving And Communications System (PACS), does not contain the detailed information requested regarding acceptance criteria and the specific study that proves the device meets those criteria.

510(k) clearances typically establish substantial equivalence to a predicate device. While they involve performance testing, the full details of the validation studies (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) are usually found in the original 510(k) submission documentation, which is not fully included here.

Based on the provided text, I can extract only very limited information related to the device's function and indications for use. The document explicitly states: "The software is not to be used for computer aided diagnostic purposes, including mammography CAD." This means it is a tool for viewing and processing images, not for making automated diagnoses or assisting in diagnostic interpretations in a way that would require specific AI-based performance metrics beyond basic PACS functionality.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, expert ground truth establishment, or advanced study designs like MRMC, because these details are not present in this document.

Here's what can be inferred or explicitly stated from the document, but it does NOT fulfill the request for acceptance criteria and a study proving their fulfillment:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided. This document details the FDA's clearance of the device as substantially equivalent to a predicate, but does not list specific performance acceptance criteria or report performance metrics from a validation study. The device is a PACS system for image management and basic processing, not a diagnostic AI tool requiring specific sensitivity/specificity metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available in the provided text.

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 available in the provided text. Given the device's indicated use as a PACS for viewing and processing, and not for computer-aided diagnosis, the type of "ground truth" typically associated with AI diagnostic devices (e.g., expert consensus on lesions) would not be directly applicable in the same way. Performance would likely be related to image fidelity, display accuracy, and functionality.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not available in the provided text.

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 available in the provided text. An MRMC study would typically be conducted for diagnostic AI tools where human reader performance is being evaluated with and without AI assistance. This device is explicitly stated as not for computer-aided diagnostic purposes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not available. The device's primary function is image management and processing. As it states, "The CereMetrix Silver software is used by trained medical professionals as a tool to aid in evaluation and information management..." and explicitly not for CAD, a standalone performance study in the context of diagnostic accuracy would not be relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not available in the provided text. For a PACS system, "ground truth" would likely involve ensuring accurate display of DICOM data, correct registration (as indicated in its functions), and accurate quantitative analysis results as compared to established methods or specifications.

8. The sample size for the training set:

Not available in the provided text.

9. How the ground truth for the training set was established:

Not available in the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CereMetrix Corp John Kelley President 991 Southpark Drive . Suite 200 Littleton, Colorado 80120

February 28, 2018

Re: K173145

Trade/Device Name: CereMetrix Silver Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: February 26, 2018 Received: February 27, 2018

Dear John Kelley:

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 requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173145/S003

Device Name CereMetrix Silver