(79 days)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.
The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:
- Femoral components
- Articular surfaces
- Tibial components
- Stem extensions
- Femoral and tibial augments
- Femoral and tibial cones.
The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.
I'm sorry, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
The provided text is an FDA 510(k) clearance letter for a Persona Revision Knee System, which is a medical device (a knee prosthesis). This document primarily focuses on the regulatory clearance process, stating that the device is "substantially equivalent" to legally marketed predicate devices.
It does NOT contain information about:
- Specific acceptance criteria metrics (e.g., in terms of sensitivity, specificity, accuracy for an AI/algorithm-based device).
- Detailed performance study results for an AI/algorithm-based device.
- Sample sizes for test sets or training sets in the context of an AI/algorithm.
- Information about expert consensus, ground truth establishment methods, multi-reader multi-case studies, or standalone algorithm performance.
The document mentions "Non-Clinical Tests" and "Clinical Tests" but these refer to mechanical and sterility testing of the knee implant and associated instruments, not to the performance evaluation of an AI or algorithmic medical device. For example, "Stem housing cantilever fatigue" and "Cadaveric design validation" are relevant to a physical medical implant, not a software algorithm. The document explicitly states, "Clinical data was not deemed necessary for the subject device," further indicating that a a large-scale clinical performance study (as would be typical for an AI/ML device) was not conducted or required for this particular type of device clearance.
Therefore, your request, which is structured around the evaluation of an AI or algorithm-based medical device, cannot be answered using the provided text, as the text describes a hardware medical implant, not a software 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.