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Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.

Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Far-East Shoe Covers." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market, but it does not detail any performance studies conducted by the manufacturer.

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