(194 days)
Build-up porcelain for fabrication of metal bonded ceramic restorations
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I am sorry, but the provided text is an FDA 510(k) clearance letter for a dental product called "Vintage Pro." It describes the regulatory classification, product code, and indications for use of this porcelain powder for clinical use.
This document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to an AI/device performance evaluation. Therefore, I cannot extract the requested information to fill in your table and answer your questions.
To help you, I would need a document that describes the clinical performance study of a device, particularly an AI-powered one, detailing its validation process.
§ 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.