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Shade adjustment of ceramic restorations

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I am sorry, but the provided text from the FDA letter (K191794) for "Vintage Art Universal" does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) clearance letter for a dental porcelain powder, classifying it as a Class II device. It primarily discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• Regulatory requirements and general controls (registration, listing, GMP, labeling, adverse event reporting).
• The intended use of the device: "Shade adjustment of ceramic restorations."

There is no mention of:

• Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device).
• Details of a clinical study or performance study, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any information regarding AI/human reader performance or MRMC studies.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the provided text. This type of information is typically found in the 510(k) summary or the full submission, not in the clearance letter itself unless specifically highlighted for a novel device or testing paradigm.

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