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The Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

The Synthes Sterile Mandible External Fixator Kit consist of a 4.0 mm Titanium Straight Rod and a bending template to be used in conjunction with the Synthes Mandible External Fixator.

The provided text pertains to the FDA 510(k) submission for the "Synthes Sterile Mandible External Fixator Kit" and its predicate device, the "Synthes Mandible External Fixator." This document is a regulatory approval summary and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Identifying the sponsor, device name, classification, and predicate device.
• Describing the device and its intended use.
• Stating that information presented supports substantial equivalence to the predicate device.
• Providing the FDA's decision regarding substantial equivalence for marketing the device.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) from this document. This kind of information would typically be found in a separate clinical or performance study report or detailed validation documentation submitted as part of the 510(k), which is not present here.

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