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The Consultiva™ Report Station is a software application intended to be used to display low resolution, non-diagnostic medical images with annotations such as regions-of-interest or CAD marks.

The Consultiva™ Report Station (RS) is a Windows-based program that gathers digitized medical images from a specified location on hard disk, and displays those images on a monitor, with Computer Aided Detection (CAD) results (or other annotations) overlaid on top of the images. The RS provides a User Interface (UI) that allows the user to initiate the display of the images . The RS also provides the capability to print a CAD report. The primary data sources for this system include the low resolution digital images and the CAD results. The visualization of CAD and images requires no explicit requirements for user manipulation of the data (zoom, pan, window level, etc). The visualization features of the RS include: The ability to display medical images at a reduced resolution and fixed size. . . The ability to enlarge an image. The ability to display the CAD results as an overlay over the displayed digitized images. .

Here's a breakdown of the acceptance criteria and study information for the Consultiva™ Report Station (RS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Consultiva™ Report Station's performance, nor does it provide quantitative results of the device's performance against such criteria. The "Testing" section broadly mentions: "Various tests of the software will be done to verify system specifications are being performed. Verification procedures with pass/fail criteria were developed to ensure that the product met all the specified requirements." This indicates that internal testing was conducted, but the details of the criteria and results are not included in this summary.

Therefore, a table cannot be constructed from the given information in the requested format.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the documentation. The submission focuses on the functionality of the display software rather than the performance of a diagnostic algorithm based on a specific dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided. As the device is for displaying images and CAD results, and not itself a diagnostic algorithm, the concept of "ground truth for a test set" in the context of diagnostic accuracy is not directly applicable to its stated function in this submission.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in the provided document. The device is described as a display system for CAD results, not a CAD system itself, nor is it intended to directly improve human reader performance in a controlled study scenario as part of this submission. The submission is focused on the display capabilities of the software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was not performed or reported as the Consultiva™ Report Station (RS) is a software application intended to display medical images and annotations (including CAD marks), not to generate diagnostic interpretations independently. It acts as a viewer for outputs from other systems (like CAD results).

7. Type of Ground Truth Used

The concept of "ground truth" as it relates to diagnostic accuracy is not applicable to the Consultiva™ Report Station (RS) as presented in this document. Its purpose is to display images and existing CAD marks/annotations, not to make a diagnosis or directly generate those annotations. The "primary data sources" mentioned are "low resolution digital images and the CAD results," implying it relies on information from other sources.

8. Sample Size for the Training Set

This information is not provided. The device is a display software, not an AI/CAD algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the Consultiva™ Report Station (RS) is a display software and does not involve AI model training.

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