(105 days)
The Progressive Orthopaedic Company Total Knee System II is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthrius, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The Progressive Orthopaedic Company Total Knee System II may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Company Total Knee System II is designed for cemented use only.
The Progressive Orthopaedic Company Total Knee System II is a fixed bearing implant available in posteriorstabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of The Progressive Orthopaedic Company Total Knee System II has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
The provided text is a 510(k) premarket notification and does not describe an AI medical device. It pertains to an orthopedic implant, specifically "The Progressive Orthopaedic Company Total Knee System II," a knee replacement prosthesis.
Therefore, the document does not contain the information needed to answer your questions about acceptance criteria for an AI device, including:
- A table of acceptance criteria and reported device performance for an AI model.
- Sample sizes for test and training sets, or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone AI performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for training data was established.
This document focuses on demonstrating substantial equivalence of a physical medical device (a knee implant) to a legally marketed predicate device, primarily through identical design features, materials, indications for use, and reliance on previously conducted preclinical performance testing of the predicate device (mechanical strength, fatigue, range of motion, etc.).
§ 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.