(97 days)
This device is indicated for patients with severe knee pain and disability due to:
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Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
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Collagen disorders, and/or avascular necrosis of the femoral condyle.
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Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
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Moderate valgus, varus, or flexion deformities.
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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 (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.
This FDA 510(k) summary for the "Persona Revision Knee System" does not describe a study involving an AI/ML device or its performance criteria. It pertains to a physical medical device (a knee prosthesis) and the tests conducted are primarily mechanical and material property assessments, not related to AI/ML performance metrics like sensitivity, specificity, or reader studies.
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study proving an AI/ML device meets them from the provided text. The document focuses on showing substantial equivalence of a knee implant to existing devices through non-clinical (mechanical, material, design) testing and intended use comparisons.
§ 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.