(184 days)
Joint replacement is indicated for patients suffering from disability due to:
degenerative, post-traumatic or rheumatoid arthritis;
avascular necrosis of the femoral condyle;
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
moderate valgus, varus or flexion deformities;
treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used for cemented applications.
The REBEL™ 3DKNEE SYSTEM is a line extension to the current 3DKNEE system. It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75, tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE, and tibial base implants made from cast CoCr alloy per ASTM F75.
The provided document is a 510(k) summary for the Rebel 3DKNEE System, which is a total knee replacement system. It does not describe a study involving an algorithm or AI, nor does it present acceptance criteria or performance data in the context of an AI device. Instead, it focuses on the substantial equivalence of this knee implant system to predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance from this document. The document explicitly states "Clinical Testing: None provided."
The information requested is primarily relevant for studies evaluating the performance of AI/Machine Learning-enabled medical devices, which this document does not pertain to.
§ 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.