(88 days)
Relief of pain and restoration of knee function following the effects of osteo, rheumatoid and inflammatory arthritis, post-trauma disease effects, avascular necrosis, and total knee revision with or without varus, valgus or flexion deformity.
The tibial and femoral components are intended for use with bone cement.
The Posterior Stabilised Total Knee Replacement System is a line extension of the previously cleared Nuffield Total Knee System which has been on the market since 1989.
The device is used to restore knee function in patients with degenerative rheumatoid or osteoarthritis in cases where the degenerative process has led to non or inadequate function of the posterior cruciate ligament.
The device incorporates cobalt-chrome alloy femoral and tibial components and a UHMWPE tibial insert. Alternatively, an all-polyethylene tibial component may be implanted.
The provided text describes a 510(k) premarket notification for the "Posterior Stabilised Nuffield Total Knee System." It establishes its substantial equivalence to previously marketed devices and mentions mechanical test data and clinical use outside the US. However, it does not contain the specific information required to answer your questions about acceptance criteria or a study proving the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a detailed performance study against specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions because the necessary details are not present in the provided document.
Summary of missing information:
- Acceptance Criteria: The document does not explicitly state quantitative or qualitative acceptance criteria for the device's performance.
- Reported Device Performance: While it mentions "extensive mechanical test data confirming the devices' safety and effectiveness" and "no significant post-operative problems have been reported" from clinical use outside the US, it doesn't provide the specific results or metrics of these tests or clinical observations.
- Study Details: There's no detailed study described (sample size, data provenance, ground truth establishment, expert involvement, adjudication, MRMC study, standalone performance, training set details).
§ 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.