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A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

The TrueView 100 Pro is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The TrueView 100 Pro includes the following major components: a system monitor, touch-screen display, a touchpad, and an imaging cabinet. The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.

This document, a 510(k) Premarket Notification Summary for the TrueView 100 Pro Specimen Radiography System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable metrics.

The information provided does not include:

• A table of acceptance criteria with reported device performance.
• Specific sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
• Information on the number or qualifications of experts, or adjudication methods for ground truth in a test set.
• Details of a multireader multicase (MRMC) comparative effectiveness study or standalone algorithm performance.
• Sample size for a training set or how ground truth for a training set was established.

Instead, the submission relies on comparing the technical specifications and performance characteristics of the TrueView 100 Pro to its predicate device, the Trident® HD Specimen Radiography System (K182727), to argue for substantial equivalence.

Here's an analysis of the information available in the provided text:

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

The document provides a comparative table between the TrueView 100 Pro and the predicate device. While this table lists various technical specifications and operational parameters, it does not explicitly define acceptance criteria for each parameter and then report the TrueView 100 Pro's performance against those criteria. Instead, it compares the TrueView 100 Pro's specifications directly to the predicate's specifications to demonstrate "similarity" or "improvement."

Here's a summary of the technical comparison presented in the document, which can be interpreted as the basis for performance claims relative to the predicate:

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

The document explicitly states: "No clinical studies have been performed." Therefore, there is no test set in the sense of a clinical study, and no associated sample size or data provenance information. The testing performed was "non-clinical."

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):

Since no clinical studies were performed and no clinical test set was used, there were no experts used to establish ground truth for a clinical test set.

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

As no clinical test set was used, there was no adjudication method for a clinical test set.

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:

The document states: "No clinical studies have been performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human reader improvement with AI assistance is reported. The TrueView 100 Pro is a specimen radiography system, not explicitly an AI-assisted diagnostic device, though "CompAI Healthcare" suggests AI may be part of their general portfolio. The current submission, however, focuses on the physical radiography system.

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

The device is a "Specimen Radiography System," which produces images for human review. The submission does not describe an AI algorithm or a standalone performance evaluation of such an algorithm. The assessment is on the system's ability to produce images that are "equivalent performance and equivalent safety and effectiveness as the predicate."

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

Given the absence of clinical studies, there is no mention of "ground truth" established through expert consensus, pathology, or outcomes data. The "ground truth" for the non-clinical tests would be the established engineering and performance specifications of the device and its compliance with relevant standards (e.g., IEC 61010) via bench testing.

8. The sample size for the training set:

The document does not describe any training set as it pertains to a machine learning or AI algorithm. The device is an imaging system designed to capture X-ray images, not an AI model requiring a training set in the typical sense.

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

As no training set (for an AI algorithm) is mentioned, there is no information on how its ground truth would have been established.

Summary of the Study and Conclusion:

The "study" described is a non-clinical bench testing and verification/validation process to demonstrate substantial equivalence to a legally marketed predicate device (Trident® HD Specimen Radiography System, K182727).

The document highlights the following non-clinical tests:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

These tests were performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (given a moderate level of concern). The TrueView 100 Pro also complies with IEC 61010 standards, validated by the third-party test house Intertek.

The conclusion relies entirely on these non-clinical tests: "The comparative and other performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate Trident® HD system (K182727)." The submission asserts that the "design, operation, basic construction, and materials used are substantially equivalent to the predicate device," leading to the conclusion that the TrueView 100 Pro is "as safe, as effective, and with performance substantially equivalent to the predicate device(s)."

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