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This device is used in the general management of fractures and reconstructive surgery.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Helical Compression Anchor System, Cannulated, Model 7.3mm". This document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and provides contact information for further assistance.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, not in the FDA's decision letter.

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