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The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, which includes the facial cranium, mid-face, maxilla and mandible.

The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System devices are the sterile, single-use bone plates, meshes and screws manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Plates, meshes and screws are provided with various shapes and sizes typical of other marketed fixation devices.

Used properly, in the presence of adequate immobilization, the OSTEOTRANSMAN Bioabsorbable Bone Fixation System devices maintain accurate alignment of bone fractures and osteotomies.

The provided text is a 510(k) summary for a medical device (OSTEOTRANS™-MX Bioabsorbable Bone Fixation System) and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, often through performance data on strength and degradation. It does not contain the kind of detailed information typically found in a clinical study report that would address the acceptance criteria for algorithm performance, sample sizes for test/training sets, expert qualifications, or MRMC studies for an AI/ML device.

Therefore, I cannot provide the requested information from the given text. The text does not describe an AI/ML device or a study involving acceptance criteria for its performance.

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