Search Results

The RBK Patella Femoral Knee is intended for use in treating patients with osteoarthritis in the distal femur and patella, patients with a history of patellar fracture and those patients with failed previous surgery where pain, deformity or dysfunction persists. The device is a singleuse implant that is intended for use with bone cement.

The RBK Patella Femoral Knee System consists of femoral and patellar components.

The femoral component is anatomic in design, to provide coverage of the condyles from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A group of four pegs (posts) 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 patella components are offered in one configuration; circular, domed, all UHMWPE. The polymer components are manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The domed, all poly patella buttons are available in 5 diameters (24mm - 40mm).

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, ground truth, or adjudication methods.

The document is a 510(k) premarket notification letter from the FDA regarding the RBK Patella Femoral Knee System. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the sponsor must meet. It focuses on the regulatory approval process and the intended use of the device, rather than detailed study results or performance metrics.

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device