(28 days)
The DePuy Attune Total Knee System is intended for cemented use as a total knee replacement system.
Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
The subject device is a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components
The provided text does not describe an AI medical device or a study involving AI. It is a 510(k) submission for a Total Knee System and specifically concerns an extension of the product's shelf life (from 5 years to 8 years) for certain components made from AOX Polyethylene that are gamma irradiated.
Therefore, I cannot extract information related to:
- Acceptance criteria for an AI device.
- Sample size for a test set or data provenance for an AI study.
- Number of experts for ground truth establishment for an AI study.
- Adjudication method for an AI study.
- Multi-reader multi-case (MRMC) comparative effectiveness study for AI.
- Standalone performance for an AI algorithm.
- Type of ground truth for an AI study.
- Sample size for a training set for AI.
- How ground truth for a training set was established for AI.
The document discusses non-clinical testing to support the shelf-life extension, specifically:
- Material Oxidation Index/Resistance Testing (ASTM F2102-17, ASTM F2003)
- Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3, ASTM F1877-05)
It explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella components and the predicate devices."
In summary, the provided text does not contain the information requested as it pertains to a mechanical medical device (knee implant) and a shelf-life extension, not an AI device or an AI study.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.