(30 days)
The Columbus Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
The Columbus Knee is designed for use with bone cement.
The Columbus Total Knee System AS includes both CR and PS variants of the femoral and tibial components for cemented use with the previously cleared UHMWPE Columbus tibial inserts. The Zirconium Nitrate ZrN coating is the only change to the previously cleared Columbus Total Knee System. The coated components are still made from Cobalt Chrome alloy (CoCrMo).
The provided document is a 510(k) summary and FDA clearance letter for the Columbus Total Knee System AS. It describes a medical device, a knee implant, and its substantial equivalence to previously cleared devices.
However, this document does not contain any information about a study involving acceptance criteria for device performance based on AI/algorithm performance. The "PERFORMANCE DATA" section states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications All roquired (50.mg per or Orthopedic Devices-The Basic Elements' were done where applicable." This refers to standard engineering and biocompatibility testing for orthopedic implants, not an AI-based performance study.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria, reported device performance, sample sizes, ground truth establishment, or AI-related effectiveness studies, as this information is not present in the provided text.
§ 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.