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The OptiLock® VL Distal Radius Plating System consists of a series of plates, screws and locking pegs that are intended for the fixation of intra-articular and extra-articular fractures involving the distal radius, ulna (and other small bones). This system is also intended for use in osteopenic bone. Specific indications include:

1. Fixation of intra-articular and extra-articular fractures
2. Treatment of mal-unions
3. Treatment of non-unions
4. Osteotomies
5. Wrist arthrodesis

The OptiLock® VL Distal Radius Plating System is comprised of a series of anatomically contoured plates, and locking, variable angle locking and non-locking screws, as well as locking pegs intended to be used in the distal radius, ulna (and other small bones). This system may also be used in osteopenic bone. The plates are available in several styles to address the anatomy of the distal radius/ulna. The screws are available in two diameters, in locking, non-locking and variable angle locking styles. Locking pegs are also available as an option for stabilizing the plate to the bone.

The plates and screws of the OptiLock® VL Distal Radius Plating System are fabricated from titanium alloy (Ti-6Al-4V), which conforms to ASTM specification F-136, or stainless steel alloy which conforms to ASTM specification F-138 or F-139. Plates and screws fabricated from titanium alloy are anodized to color-code the different sizes to assist the surgeon with size selection.

The provided text is a 510(k) Summary for the Biomet Trauma OptiLock® VL Distal Radius Plating System. This type of submission is for medical devices, specifically orthopedic implants, which are typically evaluated based on substantial equivalence to existing legally marketed predicate devices, rather than through studies involving AI or diagnostic performance metrics.

Therefore, the document does not contain the information requested in the prompt, such as acceptance criteria based on device performance metrics (like accuracy, sensitivity, specificity), details of a study proving such performance, sample sizes for test or training sets, data provenance, expert ground truthing, adjudication methods, or MRMC studies.

Instead, the document focuses on:

• Device Description: What the device is made of and its components.
• Indications for Use: What the device is intended to treat.
• Summary of Technologies: Stating that the technology is similar to other legally marketed devices.
• Substantial Equivalence: Arguing that the device is as safe and effective as predicate devices already on the market, primarily based on engineering analysis rather than clinical performance studies against specific criteria.

Therefore, I cannot fulfill the request as the essential information related to performance criteria and a study proving device performance (as would be applicable for diagnostic or AI-driven devices) is not present in the provided text.

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