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The Telegraph® Humeral Nail is indicated for proximal and/or diaphyseal fractures of the humerus.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Telegraph® Humeral Nail." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document is a regulatory clearance letter and does NOT contain the details of acceptance criteria, study design, or performance data that you've requested.

Regulatory submissions like 510(k)s often include such information, but this specific public letter only confirms the clearance and states the indications for use. To get the information you asked for, one would typically need access to the full 510(k) submission and supporting scientific data, which is usually proprietary and not publicly disclosed in this format.

Therefore, I cannot provide the requested information based on the input text.

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