(116 days)
Joint replacement is indicated for patients suffering from disability due to:
· degenerative, post-traumatic or rheumatoid arthritis;
· 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;
· treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS Tibia which are intended for cementless applications. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
EMPOWR Revision Knee™ is intended for total knee prosthesis. The system consists of the sterile implants; EMPOWR Revision Femur, EMPOWR Stem Extender, and EMPOWR Femoral Augments (Distal and Posterior)- Universal. Non-sterile reusable instruments and trials are included as accessories.
The femur component can optionally be used with a stem extender and/or augments to suit a variety of surgeon preferences and patient anatomies.
This FDA 510(k) submission for the EMPOWR Revision Knee™ does not involve an AI/ML device. It is for a traditional medical device, specifically a knee replacement prosthesis.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details in the context of AI/ML is not applicable to this document.
The document describes material and mechanical performance testing for the knee prosthesis against recognized FDA standards and internal protocols to demonstrate substantial equivalence to predicate devices, as specified in Section VII (Performance Testing) on page 4. However, these are not AI/ML performance metrics.
In summary, the provided document does not contain information about an AI/ML device, its acceptance criteria, or the studies proving it meets those criteria.
§ 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.