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Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations.

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The provided document is a 510(k) premarket notification letter from the FDA for a device named "Zirkonzahn Ice," which is classified as "Porcelain Powder for Clinical Use." This document primarily deals with the administrative notification and clearance process rather than detailed study results or acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from this document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not necessarily a demonstration of meeting specific performance criteria through a new study.

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number or qualifications of experts used to establish ground truth.
• Adjudication method for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results from a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

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