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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.

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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.

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