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For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis by using ceramic press technique.

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The provided text is a 510(k) premarket notification letter for a dental porcelain powder, "Super Porcelain EX-3 Press." This document does not describe acceptance criteria or a study proving device performance against such criteria.

The letter is a regulatory approval document from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It confirms that the device can be marketed subject to general controls and other FDA regulations.

Therefore, I cannot provide the requested information based on the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes or data provenance for any test set.
3. Information on the number or qualifications of experts for establishing ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. The sample size for any training set.
9. How ground truth for any training set was established.

This document is solely an FDA clearance letter and does not delve into the technical study details that would typically be found in a 510(k) submission's performance data section.

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