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The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and 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.

The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and 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. The plates are available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.7 mm self-tapping screws, with a low plate/screw profile.

This document is a 510(k) summary for a medical device (Synthes Midfacial System) and does not describe a study involving an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device cannot be extracted from the provided text.

The document primarily focuses on:

• Device Description: The Synthes Midfacial System, a plate and screw system for midfacial and craniofacial surgery.
• Predicate Device Comparison: It compares the Synthes system to the Howmedica Luhr Pan Fixation System.
• Basis for Equivalence: It states that equivalence is "Based on mechanical test results," implying physical/mechanical testing, not a clinical study involving AI.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, human reader studies, or ground truth establishment.

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