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The VersaVision is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

The Faxitron VersaVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 8X) from the <15 micron focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 15 x 24 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 15 x 24 cm in size through the use an integrated detector and Faxitron Vision Specimen Radiography software.

The provided text is a 510(k) premarket notification for the Faxitron VersaVision device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria in the context of clinical performance (e.g., diagnostic accuracy for an AI/CAD system).

Instead, the document details the technical specifications, intended use, and nonclinical performance data testing against regulatory standards for an X-ray system. It does not describe a study involving specific acceptance criteria for diagnostic performance, sample sizes for test sets, ground truth establishment, or human reader performance.

Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of submission presented.

However, I can extract information related to the device's technical specifications and compliance with regulatory standards.

Here's the closest interpretation of your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't define "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) for a diagnostic study. Instead, it refers to compliance with performance standards for X-ray systems.

2. Sample size used for the test set and the data provenance

This information is not provided because the document describes testing against regulatory performance standards for an X-ray system, not a clinical study involving a "test set" of patient data for diagnostic evaluation. The testing would involve engineering and physics measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of diagnostic accuracy, is not mentioned as this is a submission for an X-ray system's technical and safety performance, not a diagnostic algorithm.

4. Adjudication method for the test set

Not applicable for the same reasons as above.

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 applicable. The device is a specimen X-ray system, not an AI or CAD system designed to assist human readers, and no MRMC study is mentioned.

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

Not applicable. The device is an X-ray imaging system, not a standalone algorithm.

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

Not applicable. For this type of device submission, the "ground truth" relates to physical measurements and technical specifications, not clinical diagnoses.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable.

Summary of what the document does provide:

The document concerns the Faxitron VersaVision, a Cabinet X-ray system for imaging excised specimens. The "study" referenced is the nonclinical performance data testing and review to demonstrate compliance with established regulatory standards for X-ray systems. This includes:

• Compliance with 21 CFR 1020.40 (Cabinet X-ray Systems)
• Compliance with Laser performance standards 21 CFR 1040.10 and 21 CFR 1040.11 (if applicable, though not explicitly stated as applying beyond the X-ray system itself)
• Compliance with European EMC Directive
• Compliance with Safety testing to IEC 61010

The document concludes that based on this documentation and testing, the VersaVision is safe, effective, and substantially equivalent to its predicate devices.

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