(143 days)
The Global Resurfacing Unicompartmental (GRU) Knee System is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial conclyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant that is intended for use with bone cement.
The Global Resurfacing Unicompartmental Knee System consists of femoral and tibial components. The femoral component is anatomic in design, to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A central keel and post on the back of the femoral component assists in cement fixation and rotational stability. The device is manufactured from cobalt chrome alloy that conforms to ASTM F-75-01. The tibial component is semi-lunar in configuration and manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The tibial component is universal in geometry.
The provided text is related to a 510(k) premarket notification for a medical device: the Global Resurfacing Unicompartmental Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for a novel technology or AI algorithm.
Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, as typically found in AI/ML device submissions, is NOT present in this document.
The document primarily covers:
- Device Name: Global Resurfacing Unicompartmental (GRU) Knee System
- Sponsor: Global Orthopaedic Technology USA, Inc.
- Classification Name: Knee Joint, Femorotibial, Metal/Polymer, Semi-constrained, Cemented Prosthesis (21 CFR 888.3530)
- Intended Use: Partial replacement of articulating surfaces of the knee when only one side is affected due to various conditions (degenerative disease, fractures, deformity, revision arthroplasty). Single-use, intended for implantation with bone cement.
- Device Description: Consists of anatomic femoral component (cobalt chrome alloy ASTM F-75-01) and semi-lunar tibial component (UHMWPE ASTM F-648-00).
- Potential Risks: Standard risks associated with joint replacement devices (e.g., reaction to bone cement, loosening, infection, fracture, wear).
- FDA Decision: Substantial equivalence based on the 510(k) submission, allowing the device to be marketed.
In summary, the provided text does not contain the information required to populate the requested table and answer the specific questions related to acceptance criteria and performance studies for an AI/ML device.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.