(90 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. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, and EMPOWR POROUS Tibia which are intended for cementless applications.
The EMPOWR Universal Tibial Baseplate Implant is a line extension to the EMPOWR Knee platform to include a tibial baseplate implant with accessories (stem extensions and augments) and instruments, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.
This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the "EMPOWR Universal Tibial Baseplate." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document pertains to a traditional medical device (a knee implant) and focuses on demonstrating substantial equivalence to existing predicate devices. The "Non-Clinical Testing" section mentions engineering tests (fatigue, strength, etc.) typical for physical implants, but these are not related to AI/ML performance. The document explicitly states: "Clinical Testing: Clinical testing was not required / performed."
Therefore, I cannot extract the requested information about acceptance criteria and a study from the provided text for an AI/ML device. The questions you've posed (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth) are highly specific to the validation of AI/ML algorithms in medical imaging or diagnostics, which is not the subject of this FDA submission.
§ 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.