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The SCT-6800TH is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TH is basically similar in design , composition and function to the SCT-7000TH(K955253). Therefore, the intended use of the SCT-6800TH is the same as that of the predicate device SCT-7000TH(K955253).

The SCT-6800TH is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TH is basically similar in design , composition and function to the SCT-7000TH(K955253).

The provided text is a 510(k) submission document for a medical device: the Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TH. This document is a regulatory approval letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) summary typically includes a declaration of substantial equivalence to a predicate device based on similar design, composition, and function, or performance data demonstrating equivalence. However, the provided text only states that the SCT-6800TH is "basically similar in design, composition and function to the SCT-7000TH (K955253)" and that "the intended use of the SCT-6800TH is the same as that of the predicate device SCT-7000TH (K955253)."

Therefore, I cannot extract the requested information as it is not present in the provided document. The document essentially confirms that the FDA reviewed the information provided by Shimadzu Medical Systems and determined the device to be substantially equivalent to a previously marketed device (SCT-7000TH), allowing it to be marketed. Performance studies, if conducted, would have been part of the full 510(k) submission, not typically detailed in this introductory letter.

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