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The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.

The Precimed Hip Screw System is a compression fixation system used for the treatment of femoral neck and distal femoral fractures. It consists of compression plates, lag screws, compression screws, bone screws and angled blade plates.

I am sorry, but the provided text only contains an FDA 510(k) summary for the "Precimed Hip Screw System" and related correspondence. This type of document is for a medical device (an implantable screw system), not an AI or software-based device that would have performance acceptance criteria, a test set, expert ground truth, or an MRMC study.

Therefore, I cannot extract the information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods as these are not relevant to this type of device and are not present in the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

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