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Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extraarticular, intra-articular, joint depression, tongue type and severely comminuted fractures.

Synthes LCPs are designed to address complex fractures of the calcaneus and are applied to the lateral side. The plate has 15 threaded screw holes, which accept 2.7 mm and 3.5 mm cortex screws, as well as 3.0 mm locking screws. The plates are 2.0 mm thick, 69 mm and 76 mm in length, and are available for right and left placements.

I am sorry to inform you that the provided text does not contain the information requested about acceptance criteria and a study proving a device meets them.

The document is a 510(k) summary for Synthes Locking Calcaneal Plates, primarily focused on regulatory submission details. It includes:

• Device name and classification
• Predicate device
• Device description
• Intended use
• Material
• A letter from the FDA confirming substantial equivalence
• Indications for Use statement

There is no mention of:

• Acceptance criteria for performance
• Any specific study that evaluated device performance against acceptance criteria
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study results.

This document is a regulatory filing for market clearance based on substantial equivalence to a predicate device, not a performance study report.

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