Search Results

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.

The provided text is a 510(k) summary for the Skeletal Dynamics Total Wrist Arthroplasty System (TWA). It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, reported device performance metrics (numerical data for sensitivity, specificity, AUC, etc.), sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section lists various mechanical tests conducted according to ASTM and ISO standards, but these are for evaluating the physical properties and durability of the implant components, not for assessing the performance of a software or AI-driven diagnostic device against clinical outcomes or expert ground truth.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study design related to AI performance, as this information is not present in the provided document.

The document indicates a physical medical device (Total Wrist Arthroplasty System), not a software or AI-based diagnostic device. The "performance testing" refers to mechanical and material testing to ensure the safety and effectiveness of the implant itself, not to the performance of an algorithm against clinical data.

Ask a specific question about this device