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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 indicated for:

· Non-inflammatory degenerative ioint 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

Signature Orthopaedics' World Cup components are intended for cementless fixation only.

The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the World Cup System (K201278 and K241690) is to notify the FDA of additional geometrical variants of the World liner available in crosslinked UHMWPE (XLPE) and Vitamin-E Stabilized, 100kGy crosslinked UHMWPE (Vit-E HXLPE) material options.

The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded, lateralised, high wall, face changing and eccentric variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head.

The provided document is an FDA 510(k) clearance letter for a medical device called "World Liner," which is a component of a hip replacement system. It primarily details the regulatory clearance process, the device's indications for use, and a comparison to predicate devices, emphasizing that the new "World Liner" variants are substantially equivalent to previously cleared versions.

However, this document does not contain any information about acceptance criteria, specific study designs (like MRMC or standalone performance studies), sample sizes for test or training sets, expert qualifications, or ground truth establishment methods as would be expected for an AI/ML-based device submission.

The "Performance Testing" section is extremely brief and only mentions "Engineering evaluations" and "Range of Motion assessment per ISO 21535." These are typical for mechanical devices to demonstrate physical performance and compatibility, not for evaluating the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present.
• Sample sizes used for the test set and data provenance: Not mentioned.
• Number of experts used to establish ground truth and qualifications: Not mentioned, as there is no apparent AI/ML ground truth evaluation.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study details: Not mentioned.
• Standalone performance details: Not mentioned.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not mentioned.
• How ground truth for the training set was established: Not mentioned.

This document is for a mechanical medical device (hip liner), not an AI/ML-driven device. As such, the type of performance data and evaluation criteria you are asking about (which are relevant for AI/ML) are not applicable or present in this context.

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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.

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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 indicated 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

Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, and World Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve. Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture .
• Fracture dislocation of the hip .
• . Avascular necrosis of the femoral head
• . Non-union of femoral neck fractures
• . Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

Signature Orthopaedics' World™ Hip Stem is a circular tapered stem with longitudinal ribs intended for single use and cementless fixation in total hip arthroplasty. The stem is manufactured from forged Ti6Al4V alloy as per ASTM F136. It features a grit blasted body and a 12/14 taper connection with the trunnion surface roughness as Rz 2.5, which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.

Signature Orthopaedics' World™ Acetabular Cups are metal backed cementless acetabular cups with highly cross-linked polyethylene liner intended for use in total hip arthroplasty. The shells are available in a three hole configuration, which allows use of supplemental bone screws for supplemental fixation. The World™ Acetabular Cups are compatible with WorldTM Liners.

Signature Orthopaedics' World™ Liners are designed to articulate with a femoral head of appropriate diameter. The liners are available in neutral, 10° hooded and 20° hooded, allowing the option to address potential joint stability concerns.

The provided text is a 510(k) summary for a medical device (World™ Hip System), not an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies for an AI/ML model. The document describes pre-clinical testing for a hip replacement system, focusing on mechanical properties and material characteristics to demonstrate substantial equivalence to predicate devices.

Specifically, the document does not provide any information about:

• Acceptance criteria table for an AI/ML model.
• Performance of an AI/ML device (sensitivity, specificity, AUROC, etc.).
• Sample sizes for test or training sets for an AI/ML model.
• Data provenance (country, retrospective/prospective) for AI/ML data.
• Number/qualifications of experts for AI/ML ground truth establishment.
• Adjudication methods for an AI/ML test set.
• Multi-reader multi-case (MRMC) studies for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML (e.g., pathology, outcomes data).
• How ground truth was established for an AI/ML training set.

The document is solely focused on the mechanical and material testing required for a traditional hip implant device, such as range of motion, fatigue, and wear testing, to support its 510(k) clearance based on substantial equivalence to existing devices.

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