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PL8 Wrist Reconstruction Plate is indicated for the treatment of intra-articular and extra-articular fractures and osteotomies of the distal radius.

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I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "PL8 Wrist Reconstruction Plate". This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or any other details related to the evaluation of a device's performance through a study.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...".

This means the device was cleared based on its substantial equivalence to a predicate device, not through a performance study that would typically involve acceptance criteria and data analysis as described in your request. Therefore, I cannot extract the requested information from this document.

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