(239 days)
The Unicompartmental Knee Resurfacing Prosthesis (UniCAP ™) is indicated for use as a partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.
The Unicompartmental Knee Resurfacing Prosthesis (UniCAP™) incorporates a low-profile femoral articular component that mates to a taper post via a taper interlock. The femoral resurfacing component articulates against an allpolyethylene tibial resurfacing component. The UniCAP™ implants allow resurfacing of the compartment utilizing the undisturbed compartmental structures and soft-tissues. The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The femoral articular component has a bone contact surface that is coated with a spray-applied CP Titanium coating (identical to sponsor's previously approved devices) and a xpolished articular bearing surface. The taper post component is a cylindrical threaded stem 20mm in length, manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The post has a tapering major and minor diameter, a full-length cannulation, and a proximal female taper bore. The tibial resurfacing component is comprised of ultra high molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM D 648. The tibial component is offered in a range of thickness ( 6.0 mm, 6.5 mm, 7.0 mm and 7.5 mm) accommodate a variety of tibial surface conditions. The components have been designed to allow a minimum amount of bone and soft tissue resection. The UniCAP™ system offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular components to the existing anatomy.
The provided document is a 510(k) summary for a medical device called the "Unicompartmental Knee Resurfacing Prosthesis (UniCAP™)". This type of document is filed with the FDA to demonstrate substantial equivalence to an already legally marketed device, not to present a study proving a device meets specific acceptance criteria in the way a clinical trial would for performance metrics.
Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/ML device performance or clinical outcomes.
Instead, this document focuses on:
- Substantial Equivalence: Comparing the UniCAP™ device to existing, legally marketed unicompartmental knee systems. The acceptance criteria here are that the new device is as safe and effective as the predicate devices, which is assessed through design, materials, and intended use comparison.
- Device Description: Detailing the materials, components, and design of the UniCAP™ device.
- Indications for Use: Defining the specific conditions and patient populations for which the device is intended.
Since the document is a 510(k) summary for a physical orthopedic implant, it would not include information relevant to AI/ML device testing criteria such as:
- A table of acceptance criteria and the reported device performance: Not applicable for this type of submission. Performance is implied through substantial equivalence to predicate devices, not specific performance metrics against defined acceptance criteria in a study.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML device.
- Number of experts used to establish the ground truth and their qualifications: Not applicable. There is no ground truth concept for this type of device in this document.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance (algorithm only): Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a regulatory filing for an orthopedic implant seeking marketing clearance through substantial equivalence, not a clinical study report or a technical performance evaluation against specific acceptance criteria for an AI/ML device.
§ 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.