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Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

Synthes Tibial Nail System Ex is composed of cannulated tibial nails, 5.0 mm dual core locking screws and end caps. The 5.0 mm dual core locking screws, end caps, and Synthes commercially available locking screws and locking bolts are used to secure the nail in the bone, preventing rotation and axial compression.

This document describes a 510(k) submission for the Synthes (USA) Tibial Nail System EX, which is a medical device. The information provided is primarily for regulatory clearance and does not include details on acceptance criteria for device performance studies, nor does it present results from such studies.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this data is not present in the provided text. The document focuses on regulatory compliance, outlining the device description, indications for use, predicate device, and the FDA's decision regarding substantial equivalence.

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