(239 days)
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.
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.