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The Synthes MatrixORTHOGNATHIC Plating 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, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use: Fractures of the midface and craniofacial skeleton . LeFort I osteotomies, sagittal split ostcotomies and . genioplasties Orthognathic surgery including reconstructive procedures

The Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

The provided text is related to a 510(k) summary for a medical device called the "Synthes MatrixORTHOGNATHIC Plating System." It outlines the device description, intended use, and substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

Therefore, I cannot provide the requested information based solely on the input provided. The 510(k) summary focuses on regulatory approval based on equivalence to existing devices, not on a detailed performance study with specific acceptance criteria and outcome measurements.

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