(66 days)
SR Phonares II denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.
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I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The provided text is an FDA 510(k) clearance letter for a device called "SR PHONARES® II," which is a "Plastic Denture Tooth." This document only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory compliance information. It does not contain any technical performance data, study results, or specific acceptance criteria.
To answer your request, I would need a document that describes the device's technical specifications, performance goals, and the results of a study designed to demonstrate those goals were met.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.