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The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.

This document is a 510(k) premarket notification for a medical device called the "Total Wrist Arthroplasty System (TWA)." It is a submission to the FDA seeking clearance to market this device, demonstrating its substantial equivalence to a previously cleared predicate device.

The provided text does not describe:

• Acceptance criteria for an AI/software device.
• A study proving a device meets acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).
• Any details about sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment for AI.

Instead, this document is a regulatory submission for a physical medical implant (a wrist joint replacement system). The "Performance Testing" section refers to sterilization validation and material testing (CoCr, CPTi, UHMWPE, Ti 6AL-4V ELI) as per ISO standards (ANSI/AAMI/ISO 11135 and ISO10993-7), not AI/algorithm performance.

Therefore, I cannot fulfill your request using the provided input as it pertains to an AI/software device's acceptance criteria and study data. The document describes a traditional medical device (implant) and its manufacturing/sterilization validation.

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