(122 days)
MicroPort Total Knee Systems are in knee arthroplasty in skeletally mature patients with the following conditions:
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noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis:
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inflammatory degenerative joint disease including rheumatoid arthritis;
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correction of functional deformity:
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revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
Non-porous MicroPort total knee replacement implants are for cemented use only.
The EVOLUTION® Stemmed CS Femur is a line extension of the EVOLUTION® revision knee system product line. The device is a stemmed distal femoral knee joint replacement implant design to address bone-on-bone bearing conditions in a patient's knee where there is also a lack of bone stock or quality, but intact and sufficient collateral ligaments. An optional polyethylene stem cap designed to obstruct bone cement migration into the trunnion is packaged with the subject femoral component in the event no stem extension or adapter is used. The design features are summarized below:
- o Manufactured from Cobalt Chrome Alloy
- o CS design, sizes 1-8, left and right
- Compatible with 510(k) cleared EVOLUTION® Revision Stem Extensions, ● EVOLUTION® Revision Offset Adapters, EVOLUTION® Stem Adapters, EVOLUTION® Revision Femoral Augments, EVOLUTION® MP CS Tibial Inserts, EVOLUTION® Adaptive CS Tibial Inserts, and ADVANCE® Patella Components.
The provided document (K182125) is a 510(k) Premarket Notification for a medical device called the "EVOLUTION® Stemmed CS Femur," which is a component of a knee replacement system. This document does not describe acceptance criteria for an AI/ML medical device, nor does it detail a study proving such a device meets acceptance criteria.
The document discusses the substantial equivalence of a physical medical implant (a stemmed femoral component for knee arthroplasty) to existing predicate devices. It relies on non-clinical testing (e.g., range of motion, stress analysis) of the predicate devices and material equivalence to demonstrate safety and effectiveness.
Therefore, I cannot provide the requested information for acceptance criteria and study proof for an AI/ML medical device based on the given input. The categories in the request (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth) are relevant to the evaluation of AI/ML software as a medical device (SaMD), but they are not applicable to the premarket notification for a physical knee implant as described in K182125.
§ 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.