(87 days)
Zirprime is intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.
The document is primarily a letter from the FDA to Noritake Company, Incorporated, confirming the substantial equivalence of their device, Zirprime, a porcelain powder for clinical use (Product Code: EIH, Regulation Number: 21 CFR 872.6660). It outlines regulatory compliance requirements but does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Information about training sets.
To obtain this kind of information, you would typically need to consult a more detailed submission document, such as the full 510(k) submission, if it were publicly available and contained performance data. The provided document is a notification of clearance, not a technical report on performance.
§ 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.