Search Results

CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require low fusing porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.

CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy.

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental casting alloy, "Concord 72." It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

While the document includes the device name, regulation number, product code, and indications for use, it does not detail:

1. Acceptance criteria for performance.
2. Reported device performance against any criteria.
3. Sample sizes for test sets or training sets.
4. Data provenance (country of origin, retrospective/prospective).
5. Number or qualifications of experts for ground truth.
6. Adjudication method.
7. Multi-reader multi-case (MRMC) comparative effectiveness study details.
8. Standalone (algorithm only) performance.
9. Type of ground truth used.
10. How ground truth for the training set was established.

Therefore, I cannot provide the requested table or study details based on the given input.

Ask a specific question about this device