(368 days)
Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include ternoral, titbial and patellar replacement in a wide size range of patients who require implantation due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, pseudo-gout or complications from a falled prosthesis.
The Kirschner Knee Modified encompasses the Kirschner Performance Total Knee System, Kirschner TC-IV Total Condylar Knee System and Kirschner HybridFit Total Knee.
Kirschner Performance Total Knee System features an anatomically designed cast cobalt chromium femoral component whose geometry allows for maximum range of motion and size interchangeability. It comes with a non-porous coated proximal supracondylar flange and two non-porous coated fixation pegs to minimize stress shielding and permit compression between the porous coated surface and bone. Five sizes in left/right anatomic configurations are available to better match the patient's anatomy. The modular titanium tibial component has four screw holes and comes with either a cruciate or round Available is an all polv tibial component. There are femoral and tibial stem. augmentations to fill cavitary defects.
Kirschner TC-IV Total Condylar Knee Svstem features a cobalt chromium femoral component with a "waffled" non-porous coated proximal flange and two non-porous fixation peas. The one-piece cobalt chromium tibled component has a posterior recess allowing for the retention of the posterior cruciate ligament.
The UHMWPE patellar component for both the Performance and TC-IV knee systems come in porous-coated metal-backed or all UHMWPE options.
The HybridFit cobalt chrome tibial tray accepts the TC-IV or Performance bearing inserts and can be used with either the Performance or the TC-IV femoral component.
These knee devices are intended for use with bone cement.
The major changes are in material and method of the porous coating and in the manufacturing process of the Ultra High Molecular Weight Polyethylene.
Porous coated Kirschner Knees Modified features plasma spray coating of titanium alloy powder. The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure.
The polyethylene components are of ArCom UHMWPE, Biomet's improved polyethylene components.
This document describes a medical device, the Kirschner® Knee Modified, which is a total knee replacement system. It details the device's components, indications for use, and potential risks, as well as asserting its substantial equivalence to other legally marketed devices.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/ML medical device would. The information is typical of a 510(k) submission for a traditional, non-software medical device.
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.
The closest relevant statements are:
- "The integrity of this coating has been proven in the performance of many Biomet joint prosthesis previously reviewed by the FDA. There have been no reported incidents of coating failure." This refers to previous FDA reviews and lack of reported incidents, but not a specific, controlled study with defined acceptance criteria and performance metrics for this specific modified device.
- The comparison to other "substantially equivalent" devices (Maxim Total Knee System, AGC 2000 Total Knee Prosthesis) is a regulatory pathway, not a performance study against acceptance criteria.
In summary, the provided text does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested.
§ 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.