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The STATIS dental handpieces and drives are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth.

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This document is a 510(k) clearance letter from the FDA for a dental handpiece. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does NOT contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The classification of the device (Class I).
• Applicable regulations for the device.
• The intended use of the device ("removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth").

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as that information is not present in the provided text.

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