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The MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.

The MiniCAT 2D is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence and produces two dimensional views. MiniCAT 2D provide immediate access to images at the patient's point-of-care resulting in faster diagnosis and treatment. The MiniCAT 2D system consists of a high voltage x-ray generator, 360-degree rotational overhead gantry, x-ray tube assembly, x-ray controller, fixed detector panel, and x-ray controls containing a "power distribution unit and operator PC (user interface)."

This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria for a new AI/algorithm feature. Instead, it is a 510(k) summary for a general X-ray system (MiniCAT 2D) seeking substantial equivalence to a predicate device (Carestream DRX-Evolution).

The document details the device description, indications for use, and a comparison of technological characteristics to the predicate device to demonstrate substantial equivalence, rather than providing performance data for a specific algorithm or AI component.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

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