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TRON is a mobile X-Ray imaging system with fluoroscopy and tomography capability that is intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture (such as the head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot).

The TRON is a mobile fluoroscopy and cone-beam CT x-ray system for point-of-care (POC) imaging. The TRON system consists of a high voltage x-ray generator, 360-degree rotational open-bore gantry, x-ray tube assembly, x-ray controller, detector panel, and x-ray controls containing a power distribution unit, onboard PC and operator PC (user interface).

The provided text describes the regulatory clearance of Xoran Technologies LLC's TRON device, but it does not contain information about specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), or a study that evaluates such performance using a test set with ground truth established by experts.

The document focuses on demonstrating substantial equivalence to a predicate device (Medtronic O-arm™ 02 Imaging System) and a reference device (Xoran Technologies xCAT) based on technological characteristics and Indications for Use.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document states that "TRON meets all the evaluation criteria for Bench Testing, SW Validation, and Product Validation tests," but it does not specify what those criteria are or report quantitative performance metrics against them.

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

Not provided. The document states "N/A - No clinical testing was conducted for the TRON" and discusses "Bench Testing, SW Validation, and Product Validation testing" but offers no details about sample sizes or data provenance for these internal tests.

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

Not applicable/Not provided. Since no clinical testing was conducted and no test set with ground truth established by experts is mentioned for performance evaluation, this information is not available.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No test set requiring adjudication is described.

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/Not provided. The TRON device is an X-Ray imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/Not provided. The TRON is a hardware imaging system; the document does not describe an "algorithm only" component with standalone performance being evaluated independently of the system's operation. Its performance is inherent to its image acquisition capabilities.

7. The Type of Ground Truth Used

Not applicable/Not provided. As no clinical or performance study evaluating diagnostic accuracy against a ground truth is described, this information is not available. The testing performed focused on safety, effectiveness, and conformance to user needs, likely through engineering and design verification/validation rather than clinical diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable/Not provided. The TRON is an X-ray imaging system, not a device relying on machine learning or AI models that require a training set in the conventional sense.

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

Not applicable/Not provided. Similar to point 8, this is not relevant for the type of device described.

In summary, the provided FDA clearance letter and its associated documents (510(k) summary) do not detail performance acceptance criteria in terms of diagnostic accuracy or a study proving such criteria are met through evaluation against a ground truth. The submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use, as is common for many 510(k) submissions for imaging devices.

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