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Normed Titanium Calcaneus Plating with Locking Screw System intended for use in Intra and extra -artcular fractures, joint depression, non-displaced and tonque type, multifragmentary fractures, stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of calcaneus bones. The system can be used in both adult and pediatric patients.

Normed Titanium Calcaneus Plating with Locking Screw System consists of a series of plates in varying length; small, medium, long which are attached to the calcaneus bone using screw fixation. The plates are available in 1.3 mm plate thickness and have fourteen threaded holes and can be contoured as needed to fit the specific anatomy. The plates can be used on both the right and left of the calcaneus. The selftapping 3.5 mm screw diameters will be available in two designs, standard screw without threaded head and screw with threaded head.

The provided text is a 510(k) summary for the Normed Titanium Calcaneus Plating with Locking Screw System. It describes the device, its intended use, and the FDA's determination of substantial equivalence. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details regarding studies proving device performance. The document focuses solely on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study data.

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