(26 days)
The OvertureTi Knee Resurfacing System"is intended to be used in the partial replacement of the articulating surfaces of the knee in instances where, due to compartmental degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or previous arthroplasty, only the one side of the joint is affected. This device is intended to be used with bone cement.
The OvertureTi Knee Resurfacing System™ is comprised of femoral implants, and a set of ancillary instruments. The femoral implants are titanium and feature a spherical polished articulating surface with a titanium nitride (TiN) coating. The tibial implants are comprised of a titanium tibial tray with an integrated ultra-high molecular weight polyethylene (UHMWPE) tibial insert. The UHMVPE has Vitamin-E infused (0.1% by weight). The femoral implants and tibial trays utilize cemented pegs and porous titanium bone-contacting surfaces to allow for fixation. The femoral implant articulates against the tibial insert in a non-constrained manner.
The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. Femoral implants are offered in oblong and round configurations. The oblong femoral implants are offered in lengths ranging 25-40mm and diameters ranging 17.5-27.5mm, and the round femoral implants are offered in diameters ranging 17.5-27.5mm. The tibial implants are offered in diameters ranging 17.5-22.5mm. The implants are provided gamma sterilized and individually packaged.
The provided text is a 510(k) Premarket Notification from the FDA for the "OvertureTi Knee Resurfacing System™." This document is a regulatory approval letter and does not contain information about a study proving the device meets acceptance criteria related to AI/ML or diagnostic performance. Instead, it focuses on the device's substantial equivalence to a predicate device for its intended use as a knee resurfacing system.
Therefore, I cannot extract the requested information about acceptance criteria for device performance in the context of an AI/ML study, nor details about sample sizes, expert involvement, or MRMC studies, as these elements are not present in this type of submission.
The "Testing" section mentions:
- "Vitamin-E UHMWPE Rationale"
- "Characterization of Vit-E UHMWPE"
- "Vitamin-E Tibial Alignment Feature Test Report"
These are related to material characterization and mechanical/design features of the implant, not to diagnostic or AI/ML performance. The conclusion states that "rationales and testing... indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." This refers to the mechanical and biological safety of the implant itself, not its diagnostic accuracy or AI assistance.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.