(84 days)
"A&E Zirconia Blanks" are pre-sintered metal-free ZrO2 ceramic blanks (Y-TZP). They are specifically designed for fabrication of sub-frames for the construction of dental prosthetics (e.g. crowns and bridges restorations etc.) with the aid of manual copy-milling machines and CAD/CAM systems.
"A&E Zirconia Blanks" are pre-sintered metal-free ZrO2 ceramic blanks (Y-TZP).
I'm sorry, but this document is a 510(k) clearance letter for the Zirconia Blanks device. It explicitly states that the device is a "pre-sintered metal-free ZrO2 ceramic blanks (Y-TZP)" for the "fabrication of sub-frames for the construction of dental prosthetics."
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be relevant to answering your request regarding the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered medical device.
Therefore, I cannot fulfill your request based on the provided text.
§ 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.