(79 days)
For use in prosthetic dentistry to create an all-ceramic prosthesis.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental ceramic product called "Grand Ceram." This document does not contain information related to the acceptance criteria, study details, or performance metrics of a device as typically found in a clinical or performance study report for AI/ML-based medical devices.
The letter confirms that "Grand Ceram" is substantially equivalent to a legally marketed predicate device, indicating it's a conventional material rather than a software-as-a-medical-device (SaMD) or an AI-enabled device that would require the kind of detailed performance study you're asking about.
Therefore, I cannot extract the requested information (acceptance criteria, sample sizes, ground truth establishment, MRMC study details, etc.) from this document. The document primarily focuses on regulatory clearance for a dental material based on substantial equivalence.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.