(77 days)
Synthes 1.3 mm Self-Drilling Screws are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Synthes 1.3 mm Self-Drilling Screws feature self-drilling self-tapping tips, stardrive recessed head, and are available in lengths ranging from 4 mm - 6 mm.
This document, a 510(k) summary, details the submission for the Synthes 1.3 mm Self-Drilling Screws. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
The provided text describes a medical device (bone screws) and its regulatory approval process, which is very different from the evaluation of an AI-powered diagnostic or therapeutic device. Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document because it does not pertain to an AI/ML device.
To answer your request, I would need a document describing the evaluation of an AI/ML device, typically found in a clinical study report or a 510(k) submission for an AI-powered product.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.