(146 days)
The A200 Knee System is intended for use in total knee arthroplasty for the following indications:
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is for cemented use only.
The Renovis A200 PS Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained prosthesis intended to be implanted to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement.
The subject of this 510k Premarket Notification are additional offerings to the Renovis A200 Knee System (K120038) resulting from customer requests to better meet patient need (anatomy and surgical technique). The additional offerings are part of the FDA cleared A200 Knee System and are called the A200 PS Knee System. The PS Knee System is a primary, posterior stabilized (PS), tri-compartmental knee replacement system to treat knee disorders resulting from degenerative diseases where the posterior cruciate ligament is absent.
The new A200 PS Knee System includes:
- Femoral components in nine (9) sizes (1, 2, 3, 3N, 4, 4N, 5, 6, and 7) in a posterior stabilized (PS) design, each for left and right sides, manufactured from CoCrMo in compliance with ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
- Tibial insert components in three (3) footprint sizes; each for the left and right sides; with articulating thicknesses ranging from 10 mm to 23 mm; in two levels of constraint - PS and PS Plus. The tibial inserts have a mechanical lock to the tray (snap mechanism). Tibial inserts are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
- Patellar components in five (5) sizes in sombrero and five (5) sizes in domed design. Patellar components are manufactured from highly cross-linked UHMWPE (with and without 0.1% by wt Vit E), and 1020 UHMWPE in compliance with ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants and ASTM F2695 -12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
- FDA cleared (K120038) Tibial tray (baseplate) components in (9) sizes, each for the left and right sides, and in each in two designs, a conical design (CoCrMo) and a keeled design (Ti6A14V)
The system also includes reusable instrumentation.
The provided text is a 510(k) Premarket Notification for the Renovis A200 PS Knee System. This document focuses on demonstrating substantial equivalence to a predicate device and provides details on the device description, indications for use, and performance testing. However, it does not include information about user studies or clinical trials with human participants, which would be necessary to derive acceptance criteria and performance data for AI-assisted human reading or standalone AI performance.
Therefore, I cannot fulfill the request as the information regarding acceptance criteria, reported device performance (in the context of AI), sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI device is not present in the provided document.
The document discusses bench testing of the physical knee implant components, such as fatigue strength and locking mechanisms, to ensure the device performs as expected. This type of testing is relevant to the mechanical integrity and functionality of the surgical implant itself, not to the performance of an AI diagnostic/assistive tool.
In summary, the provided content is for a knee implant device and does not contain the information requested about the acceptance criteria and study proving an AI device's performance.
§ 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.