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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

• · Dislocation risks (when used with SignaSure range)
  Signature Orthopaedics' Origin. Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade 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 Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at 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 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

The SignaSure Dual Mobility System is available in two configurations, a Monobloc configuration and a Modular configuration. The Monobloc configuration is a Dual Mobility acetabular system consisting of a metallic shell, cemented, and a mobile polyethylene insert to articulate within the shell as a femoral head. The Modular configuration (subject device) is a dual mobility acetabular system consisting of 2 components; a mobile polyethylene component and a metallic insert which can be used with interfacing cemented or cementless cups.

The SignaSure Poly, used in both configurations, is manufactured from highly crosslinked polyethylene (as per ASTM F648) and is spherical in geometry with outer and inner spherical conforming articular surfaces. The inner articular surface mates and retains a femoral head. The outer articular surface articulates within the highly polished inner diameter of the SignaSure Cementless or Cemented Cup to be used, or the metallic insert. The SignaSure Poly components are available in size 37 to 41 mm (outer diameter) allowing use with 22 mm and 39 to 59 mm femoral heads.

The SignaSure Logical Insert is manufactured from Cobalt Chrome (CoCr) alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedics' Logical Shell to be implanted without bone cement and the SignaSure World Insert is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and mates with Signature Orthopaedic's World Cup to be implant without bone cement. The SignaSure Logical Insert is available in 34 to 48 mm sizes whereas the SignaSure World Insert is available in 38 to 46 mm (internal diameter) sizes.

The SignaSure Cementless Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is sequentially plasma sprayed with titanium coating (as per ASTM F1580) and hydroxyapatite (as per ISO 13779-1 and ISO 13779-2) to gain cementless fixation. The SignaSure Cemented Cup is manufactured from CoCr alloy (as per ASTM F1537 and ISO 5832-12) and is grit blasted and macro textured to aid in fixation via bone cement. These cups, as from K211742, underwent no changes and were included in this submission as they interact with the subject SignaSure Poly devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "SignaSure Dual Mobility System." It is a notification of the agency's substantial equivalence determination for the device, and it details the device description, indications for use, and a summary of performance testing to support the claim of substantial equivalence to predicate devices.

Acceptance Criteria and Study for the SignaSure Dual Mobility System

The provided document describes the "SignaSure Dual Mobility System" and demonstrates its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI or diagnostic device. The acceptance criteria in this context refer to the performance benchmarks used to determine that the new device is as safe and effective as existing legally marketed predicate devices.

The information provided does not relate to an AI or diagnostic device, therefore, many of the requested fields (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set, and ground truth type) are not applicable.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" are typically related to meeting established standards and demonstrating performance comparable to predicate devices in terms of mechanical, material, and functional characteristics. The "reported device performance" in this context refers to the results of the non-clinical tests and engineering evaluations.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as this is a non-clinical, engineering testing summary, not a human clinical trial. The "test set" would refer to the number of physical device units or components subjected to each specific test. This information is typically detailed in the full test reports, not in the 510(k) summary.
• Data Provenance: Not applicable in the context of human data. The tests are non-clinical, conducted in a laboratory setting to evaluate material and mechanical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. "Ground truth" in this context would refer to established engineering standards (ASTM, ISO), and the experts would be the engineers and technicians performing and verifying the tests, who are qualified in biomechanics, materials science, and medical device testing. Their qualifications are not specified in this summary.

4. Adjudication method for the test set

• Not applicable. Performance against engineering standards is typically determined by measurements and comparison to defined limits, not through a human adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a hip replacement prosthesis, not an AI or diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a hip replacement prosthesis, not an AI or algorithm.

7. The type of ground truth used

• Ground Truth: Established international and national standards for medical device materials and mechanical performance (e.g., ASTM F648, F1537, F1580, F1820, F1875, F2582-14, ISO 5832-12, ISO 13779-1, ISO 13779-2, ISO 21535:2007). These standards define the acceptable performance characteristics. The predicate devices also serve as a comparative "ground truth" for substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a physical hip implant seeking 510(k) clearance based on non-clinical testing.

9. How the ground truth for the training set was established

• 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 treat, 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, reconstruction, hemiatthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, World and Encore 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 the 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 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

The SignaSure Dual Mobility System consists of cementless and cemented shells, and a poly component. The SignaSure Poly is manufactured from crosslinked polyethylene and is spherical in geometry with outer and inner spherical conforming articular surfaces. The inner articular surface mates and retains a femoral head. The outer articular surface articulates within the highly polished inner diameter of the SignaSure Cementless or Cemented Cup. The SignaSure Cementless Cup is manufactured from CoCr alloy and is sequentially plasma sprayed with titanium coating and hydroxyapatite to gain cementless fixation. The SignaSure Cemented Cup is manufactured from CoCr alloy and is grit blasted and macro textured to aid in fixation via bone cement.

This document is a 510(k) premarket notification for a medical device called the SignaSure Dual Mobility System, which is a hip replacement prosthesis. The document does not describe specific acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm or a diagnostic device.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway for medical devices. The performance testing mentioned is for the physical device itself (a hip implant), not for an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes, ground truth establishment, or human reader effectiveness improvement, as these concepts are not applicable to the content of the provided document.

The document does mention:

1. Performance Testing: Non-clinical testing and engineering evaluations were conducted to verify that the performance of the SignaSure Dual Mobility System is adequate for anticipated in-vivo use. The specific tests performed were:
   • Head assembly/disassembly/lever out testing
   • Range of motion analysis
   • Coating adhesion
   • Articular surface wear
   • Impingement testing
   • Post impingement lever out testing
     These tests are typical for mechanical hip implants to assess their durability, functionality, and structural integrity. The document states that these results support the substantial equivalence claim, meaning the device's performance is comparable to marketed predicate devices.

However, none of the other requested information (related to AI acceptance criteria, clinical study design for AI, training/test sets, expert adjudication, MRMC studies) is present in this FDA 510(k) document.

Ask a specific question about this device

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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