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The Swissray Tellerav AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipuroose or dedicatedapplications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position.

The major system components include: an optional floating table, x-ray generator, x-ray tube, digital AddOn Bucky: CCD camera, monitors and an image processor.

This document is a 510(k) clearance letter from the FDA for a device called "Digital Addon Multi System, Stationary X-Ray System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, the provided text DOES NOT contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory approval letter, not a scientific study report. It mentions the "indications for use" of the device, but it does not detail any performance metrics, studies, or criteria for acceptance that were tested.

Therefore, I cannot provide a response filling in the requested table and details because that information is not present in the given input.

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