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For use in the fixation of distal fractures of the upper extremity. External fixation systems allow control of bone segments including angulation, rotation and displacement.

Commuted, intra-articular distal radius fractures (Frykman-Classification III-VIII), Bilateral Colles' fracture, failed closed reduction with casting.

The Colles C Series Frame Sterile Pack is an external fixation device used in the treatment of fractures of the wrist. The system is comprised of half pins that are implanted through the skin attached to adjustable connecting rods that can apply traction. The kit also includes instrumentation required for the surgery. The change to the device is to manufacture part of the clamp from Radel instead of Celcon material.

The provided document is a 510(k) summary for the "Sterile Colles Classic Fixator" by DePuy Orthopaedics, Inc. This document describes a medical device modification (changing a clamp material from Celcon to Radel) and asserts substantial equivalence to a previously cleared predicate device (K003397). It is not a document that describes the development or validation of an AI/ML-driven medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and MRMC studies for an AI/ML device is not present in the provided text.

The document discusses:

• Device Name: Sterile Colles Classic Fixator
• Intended Use: Fixation of distal fractures of the upper extremity.
• Indications for Use: Commuted, intra-articular distal radius fractures (Frykman-Classification III-VIII), Bilateral Colles' fracture, failed closed reduction with casting.
• Change: Manufacture part of the clamp from Radel instead of Celcon material.
• Substantial Equivalence: Claimed based on the predicate device K003397, with the only change being the clamp material.

Since this 510(k) is for a material change in a mechanical orthopedic device, the concepts of "acceptance criteria" and "studies" as they relate to AI/ML device performance (e.g., accuracy, sensitivity, specificity, reader studies) are not applicable and are not mentioned.

Conclusion: The provided text does not contain the information required to answer the prompt, as it pertains to a mechanical device modification rather than an AI/ML device.

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