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The Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include:

• Diaphyseal fractures of the humeral shaft
• Fractures of the proximal humerus
• Proximal humeral fractures with diaphyseal extension
• Impending pathologic fractures
• Malunions and nonunions

The Synthes Titanium Cannulated Humeral Nail System consists of cannulated titanium intramedullary rods, and end caps in a variety of sizes designed for treatment of various humeral fractures. A 2.0mm guide wire is used with the system.

My apologies, but the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Synthes Titanium Cannulated Humeral Nail System), which primarily focuses on establishing substantial equivalence to a legally marketed predicate device.

Specifically, the document states: "Documentation is provided which demonstrated the Synthes Titanium Cannulated Humeral Nail System to be substantially equivalent to other legally marketed devices." This indicates that the regulatory pathway chosen was based on comparing the new device to existing ones rather than presenting performance data against pre-defined acceptance criteria from a specific study.

Therefore, I cannot provide the requested information, as it is not present in the given text.

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