(137 days)
The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION™ Total Knee System is for cemented use only.
The subject of this Special 510(k)-Premarket Notification is to request a performance specification modification to increase the functional range of motion for the Wright Medical Technology, Inc. EVOLUTION™ MP Total Knee System. The EVOLUTION™ MP Total Knee System consists of existing total knee implant devices. No new total knee components are being introduced as a result of this Special 510(k) premarket notification.
The EVOLUTION™ MP Total Knee System was evaluated via mechanical testing and engineering analyses; including static stability and contact area testing. A review of these results indicates that the EVOLUTION™ MP Total Knee System is equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
The provided text is for a 510(k) premarket notification for a knee system, and it does not contain any information about acceptance criteria or a study proving device performance against such criteria for an AI/ML device.
The document states that the "EVOLUTION™ MP Total Knee System was evaluated via mechanical testing and engineering analyses; including static stability and contact area testing." However, this refers to the physical knee system, not an AI/ML device.
Therefore, I cannot provide the requested information for an AI/ML device based on the given text.
If you have a document related to an AI/ML device with acceptance criteria and performance study details, please provide that.
§ 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.