(80 days)
The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.
The product is a titanium endodontic point having the same intended use as endodontic silver points; i.e. to be used during endodontic therapy to fill permanently the root canal of a tooth. The device is fabricated in various endodontic point sizes of titanium CP meeting the ASTM F 67 standard specification for unalloyed titanium for surgical implant applications.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental device (Pacific Implant Titanium Endodontic Point) and a letter from the FDA determining its substantial equivalence to previously marketed devices. It focuses on regulatory approval and classification rather than performance studies or acceptance criteria for a specific device feature or function.
Therefore, I cannot provide the requested table or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details. This information is simply not present in the given text.
§ 872.3840 Endodontic silver point.
(a)
Identification. An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal of a tooth.(b)
Classification. Class I (general 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.