Search Results

Logical Liner and World Liner: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are intended for:
· Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
· Inflammatory joint disease including rheumatoid arthritis
· Correction of functional deformity including congenital hip dysplasia
· Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
· Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

World Knee System: Patients should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. · Inflammatory degenerative joint disease including rheumatoid arthritis. - · Functional deformity such as varus, valgus or flexion deformities. - · Revision procedures where other treatments or devices have failed. - · Fractures that are unmanageable using other techniques. Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the Logical Cup, World Hip, and World Knee System, is to notify the FDA of the the change in materials used to manufacture the polyethylene components (Logical Liner, World Liners and World Knee Patella) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE) that is the subject of Masterfile MAF 2795. This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments. The Logical Acetabular System consists of an Acetabular Shell and a highly cross-linked polyethylene Acetabular Liner that is available in neutral, hooded and lateralized variants. The liner is designed to sit within an acetabular shell and articulate with a femoral head. The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head. The World Knee Patella is available in symmetrical and asymmetrical variants, with pegs. It is part of the World Knee System, which is a modular knee system consisting of a femoral component, meniscal inert, a patella and a tibial component.

The provided text does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification for orthopedic implants (hip and knee replacement components).

Therefore, I cannot provide a response with the requested information as it is not present in the input.

Reasoning for the absence of requested information:

• Device Type: The 510(k) is for physical orthopedic implants (Logical Liner, World Liner, World Knee Patella), not an AI/ML software device.
• Performance Metrics: The performance testing described focuses on material properties, mechanical integrity, and wear resistance relevant to physical implants (e.g., density, mechanical properties, melting point, fatigue crack propagation, oxidation challenge, ESR testing, wear for 5 million cycles). These are not the types of metrics typically associated with AI/ML diagnostic or prognostic performance (e.g., sensitivity, specificity, AUC).
• No AI/ML Components: There is no mention of algorithms, machine learning models, training data, ground truth establishment by experts, or any other elements common to AI/ML device evaluations.

Since the input is not about an AI/ML device, the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for AI models are not applicable.

Ask a specific question about this device