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The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece.

The device is a radiolucent external fixator capable of rotation and angulation.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the "Radiofix" device. The document is primarily a 510(k) summary and an FDA clearance letter, which focus on establishing substantial equivalence to a predicate device rather than detailing performance studies and acceptance criteria.

The information present in the text is:

• Device Name: Radiofix
• Manufacturer: Fixano S.A.
• Intended Use: "The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece."
• Device Description: "The device is a radiolucent external fixator capable of rotation and angulation."
• Substantial Equivalence: To predicate devices such as Orthopedic Innovations Cobra External Fixator (K983881) and Orthofix Non-bridging Pennig Wrist Fixator.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document.

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