(87 days)
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- Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
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- Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
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- For cemented use only.
Not Found
This FDA 510(k) clearance letter for the "Proven Knee System High Flexion Tibial Insert" does not contain information about acceptance criteria and a study proving a device meets those criteria, as typically seen for AI/ML-driven diagnostics or imaging devices.
This document pertains to a traditional medical device (a knee implant) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving performance against specific quantitative metrics that an AI algorithm would require.
Therefore, I cannot extract the requested information (points 1-9) from the provided text. The document is a regulatory clearance for a physical medical implant, not a study report for an AI-powered device.
§ 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.