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The Tornier Calcaneal Fracture Plate System is indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue-type and severely comminuted fractures.

The Tornier Calcaneal Fracture Plate System is a low profile, anatomical plate designed for the fixation of Calcaneal fractures. The plate has 7 screw holes, which accept 4mm diameter screws. The plates are 2.0 to 3mm thick, comes in 3 sizes (Large, Medium and Small) for optimal anatomic fit and are available for right and left placements. The Tornier Calcaneal Fracture Plate System is made out of 316L Stainless Steel material per ASTM F138.

The provided text describes a medical device, the Calcaneal Fracture Plate System, for which Tornier, Inc. is seeking 510(k) clearance. However, the document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document is a 510(k) summary and the FDA's response letter, which primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. There is no mention of performance metrics, clinical trials, or any study involving human or computational analysis to establish acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table or describe a study, as the input material does not contain this data.

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