(89 days)
The DePuy Biax A.F. Wrist System is intended to give patients limited wrist mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the wrist joint.
The DePuy Biax A.F. Wrist System is indicated for use as a replacement of wrist joints disabled by rheumatoid arthritis with pain, deformity and/or limited motion, degenerative or post-traumatic arthrosis, ankylosis of the wrist in malposition and advanced instability with carpal destruction
The DePuy Biax A.F. Wrist System is also indicated for revision of a failed previous wrist surgery.
CAUTION: The DePuy Biax A.F. Wrist System is for cemented use only.
The Biax A.F. Wrist System is a cemented, multiple component system to be used for the treatment, and revision, of wrist joints:
• The radial implant stem is made of ASTM F-75 Orthochrome with an articulating surface of UHWMPe. It is available in small, medium and large sizes.
• The 5-piece metacarpal implant is manufactured from F-75 Orthochrome and Titanium (Ti-6Al-4V ELI). It consists of a fixation plate, cemented and held in place with a central stem and two peripheral screws, and attached to an articulating head. All parts are available in a variety of sizes.
The provided text is a 510(k) summary for a medical device called the "Biax A.F. Wrist System", a wrist prosthesis. This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI would.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, as it relates to a diagnostic AI device.
Specifically, it lacks details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how ground truth for the training set was established.
Instead, the document primarily discusses the device's indications for use, its components, and its substantial equivalence to previously cleared predicate devices based on identical intended use, materials, sterilization, packaging, and design features.
§ 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.