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The ClearView™ Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use:

• fractures of the wrist with ligamentous instability .
• comminuted intra-articular radius fractures
• post-traumatic reconstruction for joint stiffness .
• Colles Fracture .
• distal radius fractures (Types B and C) .
• Frykman Type III, IV, VII and VIII radius fractures
• any wrist fracture requiring distraction

The device is a preassembled, mechanically adjustable external fixator and is available in three sizes (small, medium, and large). It is a four-piece construct consisting of a radiolucent polycarbonate plastic and applied to the bone with 2 pairs, with the option of a third pair, of self-drilling half-pins measuring 3mm x 110mm both cancellous and cortical. The half pins are used as bone anchors and are manufactured from medical grade stainless steel (316LVM).

The provided text is a 510(k) premarket notification for the ClearView™ Wrist Fixator, a medical device. It describes the device, its intended use, and indicates its substantial equivalence to predicate devices already on the market.

However, the document does not contain any information regarding acceptance criteria, study design, reported device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study results (such as MRMC studies or standalone performance).

Therefore, I cannot provide the requested table and information based on the given input. The 510(k) summary focuses on demonstrating substantial equivalence to already approved devices, which often relies on comparison of technical specifications and intended use rather than new clinical effectiveness studies with specific performance metrics and ground truth evaluations.

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