Search Results

The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

The Synthes MatrixMANDIBLE Plate and Screw System is the next generation of Synthes (USA) fixation systems for the mandible. The system incorporates small, medium, and large plates designed so that all plates accept all system screws. The plates are available in various shapes and thicknesses, and accept self-tapping cortex and locking screws. The implants are manufactured from CP titanium and titanium alloy.

The provided text describes a medical device submission (K063790) for "The Synthes MatrixMANDIBLE Plate and Screw System". This document is a 510(k) summary and the FDA's clearance letter.

Based on the provided text, there is no information available about acceptance criteria, detailed device performance studies, sample sizes for testing or training, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) studies.

The document does state that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. This equivalence is typically established through a comparison of technological characteristics, intended use, and performance data if applicable, but the specifics of how performance was evaluated are not detailed in this summary.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided input.

The information you are requesting would typically be found in a more comprehensive clinical or non-clinical performance study report, which is not part of this 510(k) summary.

Ask a specific question about this device