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The various clinical indications for wrist arthrodesis are at the discretion of the surgeon but in general include:

• rheumatoid wrist deformities requiring restoration of alignment and stability
• carpal instabilities
• severe unremitting wrist pain related to motion of the carpus
• other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.

Carpal Engaging Wrist Fusion Plate

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Terray Carpal Engaging Wrist Fusion Plate). It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs typically associated with AI/ML device evaluations.

Therefore, I cannot extract the requested information to fill in the table and answer the questions about a study on device performance.

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