(94 days)
The ASK System 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 arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The ASK System is designed for cemented use only.
The ASK System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a patellofemorotibial, polymer/metal/ polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray, and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the 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 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.
This document does not contain information about an AI/ML medical device. The submitted text is a 510(k) premarket notification for "The ASK System," which is a knee joint prosthesis. As such, it describes the physical and mechanical testing of the prosthesis, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text pertains to a traditional medical device (knee implant).
§ 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.