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Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

I am sorry, but based on the provided document, there is no information about the acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) summary for the Synthes (USA) Craniofacial Plate and Screw System. It primarily focuses on demonstrating substantial equivalence to predicate devices, the intended use, and the regulatory classification.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a study.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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