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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 procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.

The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView Core 100Pro-US includes the following major components: touch-screen control display, and an imaging cabinet. This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding.

The provided FDA submission for the TrueView Core 100Pro-US Core Specimen Radiography System is not an AI/ML device. It is a cabinet X-ray system used for digital X-ray imaging of surgical and core biopsy specimens. Therefore, the specific criteria requested for AI/ML devices regarding acceptance criteria, study details, human reader improvement, and ground truth establishment (for training/test sets) are not applicable to this submission.

The document discusses performance data related to the device's electrical safety, mechanical hazards, and electromagnetic compatibility, as shown by compliance with IEC 61010 standards and various functional and usability tests.

Here is a summary of the information that is applicable and found in the document:

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

The document primarily focuses on compliance with standards rather than specific acceptance criteria in the context of diagnostic accuracy for AI/ML.

2. Sample sized used for the test set and the data provenance: Not applicable as this is not an AI/ML device with a diagnostic algorithm. Performance testing focused on hardware safety and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, the document describes a traditional medical device (an X-ray system) and details its compliance with relevant safety and performance standards through bench testing, rather than an AI/ML diagnostic system that would require a test set, ground truth, and expert evaluations.

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