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The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.

The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.

The Acumed Congruent Bone Plate System is a medical device and the provided 510(k) summary explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."

Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The device obtained substantial equivalence based on its technological characteristics and intended use being similar to legally marketed predicate devices, not on specific performance data or a study demonstrating meeting acceptance criteria.

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