(230 days)
The Synthes 90 ° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.
The Synthes 90 ° Screwdriver consists of a screwdriver handle, shaft, screw holder, screw holder insert and a variety of attachments such as drill bits and screwdriver blades for manual and powered right angled pre-drilling and insertion of screws.
This looks like a 510(k) summary for a medical device (Synthes 90° Screwdriver), and not a study report that details acceptance criteria and device performance. The given document describes the device, its intended use, classification, and substantial equivalence to a predicate device, but it does not contain the kind of detailed performance study information typically requested for AI/software-as-a-medical-device (SaMD) clearances.
Therefore, I cannot provide the requested information about acceptance criteria and study details because the provided text does not contain this information. This document is a regulatory submission summary, not a clinical or performance study report.
If you have a different document or a study report, I would be happy to analyze it for the requested details.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.