(63 days)
The GMK Knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- Avascular necrosis of femoral condyle
- Post traumatic loss of joint configuration
- Primary implantation failure
Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semiconstrained liner is used, an extension stem must be implanted both on the fibial and on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.
The GMK Sphere CR Tibial Inserts are a line extension to the GMK Sphere Total Knee System and are comprised of the following products:
- Tibial insert fixed CR: Left and Right, Sizes 1-6, Thicknesses 10-11-12-13-14 mm, UHMWPE (ISO 5834-2) Type 1.
The purpose of this submission is to introduce a new GMK Sphere insert design that does not require Posterior Cruciate Ligament (PCL) release. The introduction of the subject items does not require additional instrumentation needed during the surgical procedure (with exception of the specific CR trial tibial inserts) and does not alter the intended use or outcomes.
The provided text is a 510(k) summary for a medical device (GMK Sphere CR Tibial Inserts). It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, or training set information. This document pertains to the regulatory clearance of a physical medical implant (a knee replacement component) through a substantial equivalence pathway, not the evaluation of an AI-powered diagnostic or predictive tool.
The "Performance Data" section mentions mechanical data, constraint measurements, contact pressures, dynamic physiological loads, and range of motion, but these are related to the physical properties and biomechanical function of the implant, not the performance of an algorithm.
§ 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.