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The MAGELLAN™ Intramedullary Humeral Nail System is indicated for use in long bone shaft fractures of the humerus which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, non-unions and malunions.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Magellan Humeral Intramedullary Nail System." This type of document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device's performance evaluation.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on a detailed performance study against specific acceptance criteria like those described in the prompt. While some performance testing might be included in the 510(k) submission, the clearance letter itself doesn't typically detail it in the way requested.

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