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The DX-50 is a Cabinet x-ray system that is used to provide 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.

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I am sorry, but the provided text from the FDA 510(k) letter for the Faxitron X-ray Corporation's DX-50 Digital Radiography System does not contain the specific information you are requesting regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

This document is primarily an FDA clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device and outlining regulatory responsibilities. It includes the "Indications for Use" for the device, but it does not detail the technical performance studies and their results.

To answer your questions, I would need access to the full 510(k) submission or a performance study report for the device.

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