(57 days)
The indications for use of this tibial insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic 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, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.
This component is available in seven sizes to fit into, and articulate with, the existing Foundation Baseplates and Femoral Components. This device is used in conjunction with the Foundation® Tibial Baseplates and Femurs. This insert is intended to provide more congruency between the insert and femur than is available with the primary insert. However, it will provide similar, or slightly more, congruency than the Foundation® Posterior Stabilized Knee. Anterior/posterior stability is greater than the primary insert because of the increased height of the anterior and posterior lips. Rotational stability is similar to the primary insert.
This document, K963028, describes a medical device called a "Tibial Insert." It is a summary of safety and effectiveness information for a 510(k) submission to the FDA.
The provided text does not contain any information related to acceptance criteria or studies that prove the device meets acceptance criteria in the context of AI/ML performance evaluation.
Therefore, I cannot fulfill your request for the tables and information outlined.
The document describes a mechanical implant (a tibial insert for knee replacement surgery) and discusses its design, indications for use, and comparison to predicate devices, but it contains no data on:
- Device performance metrics (e.g., accuracy, sensitivity, specificity for an AI model)
- Sample sizes for test or training sets
- Ground truth establishment
- Expert involvement or adjudication methods
- Comparative effectiveness studies with human readers
- Standalone algorithm performance
It appears the request is based on an assumption that the provided document is describing an AI/ML device, which it is not.
§ 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.