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Dental porcelain used in the manufacture of porcelain-fused-to-metal restorations. Porcelain is sold in the powder form.

Dental Porcelain - various, sold in powder form.

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a dental porcelain product. It states that the device is "substantially equivalent" to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies of an AI/algorithmic device.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory clearance, not a technical report detailing performance studies.

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