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Cases of fracture of the long leg bones are not uncommon and are usually caused by trauma. The surgical re-construction of either the tibia or femur is necessary to restore the patient back their natural alignment and gait. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections in alignment until natural healing occurs. The nails creates a sound foundation for the partial, then when healed full load bearing.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Omni-Fix, Nail System." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the FDA determined the new device is as safe and effective as a legally marketed predicate device, rather than requiring the submission of a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text.

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