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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 & fracture non-union or mal-union
• 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, hemiarthroplasty, surface replacement, or total hip replacement
• Dislocation risks (when used with SignaSure Dual Mobility System)

Signature Orthopaedics' Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only.

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

The Longboard Revision Stem is a femoral stem and a partially threaded distal locking screw intended for single use and cementless fixation for revision hip arthroplasties. The components are manufactured from titanium alloy as per ISO 5832-3 and ASTM F136 and the stem has a titanium alloy grit blast along the body. The Longboard Revision Stem is a symmetrical with a neck angle of 135°. The stem body is tapered and finned, while the distal tip is finless to allow for initial version adjustments. The stem neck features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.

This FDA 510(k) Clearance Letter for the Longboard Revision Hip Stem describes a medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions regarding acceptance criteria and study design for performance evaluation of algorithms and AI/ML systems (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing for mechanical properties and material characteristics, as is standard for orthopedic implants.

Here's an analysis of the provided information relevant to the device's acceptance criteria and the study that proves it meets them, framed within the context of a physical medical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

For physical medical devices like the Longboard Revision Hip Stem, acceptance criteria primarily revolve around:

1. Safety and Effectiveness: Ensuring the device is safe for its intended use and performs as expected.
2. Biocompatibility: Materials used must be compatible with the human body.
3. Mechanical Performance: The device must withstand anticipated physiological loads and stresses without failure for its expected lifespan.
4. Conformity to Standards: Compliance with established industry and regulatory standards.
5. Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study described to prove the device meets these criteria is the non-clinical performance testing and engineering evaluations.

1. Table of Acceptance Criteria and the Reported Device Performance

The document doesn't provide a precise "table" of numerical acceptance criteria in the format typically seen for AI/ML performance (e.g., "Sensitivity >= X%"). Instead, acceptance is inferred from the successful completion of specified engineering tests and adherence to industry standards, followed by a conclusion of substantial equivalence.

Information Not Applicable/Provided for a Physical Device:

The following points are primarily relevant to software, AI/ML, or diagnostic devices, and therefore are not applicable to this 510(k) for a physical orthopedic implant:

2. Sample size used for the test set and the data provenance: Not applicable. Testing is primarily mechanical/physical on device samples, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is its physical behavior under load, measured by engineering methods, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 for diagnostic interpretation, not an implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of image interpretation. Ground truth for this device is mechanical integrity, material properties, and functionality under specified conditions, verified by laboratory testing.
8. The sample size for the training set: Not applicable as there is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

In summary: The clearance of the Longboard Revision Hip Stem relies on non-clinical, laboratory-based mechanical and materials testing of physical device samples against established industry standards and comparison to predicate devices, to demonstrate its safety and effectiveness for its intended use, rather than on clinical data or AI/ML performance metrics.

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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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The patient 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 Orthopaedic's World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intended for cemented or cementless use by checking the package label.

The intended use of the World Total Knee System is for total knee replacement procedures in skeletally mature patients with structural joint damage. This is the same intended use as previously cleared devices for the World Total Knee System, K181530.

The World Total Knee System is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and tibial baseplate components are intended for use with or without bone cement. The femoral component, meniscal inserts and all polyethylene tibias are available as posterior stabilised or cruciate retaining variants. The femoral components are also available as anatomic asymmetrical and symmetrical design variants. The femoral component may be used with modular pegs.

The primary purpose of this Special 510(k) Device Modification to the World Knee System is to notify the FDA of the addition of titanium nitride (TiN) material coating to the femoral components (posterior stabilised{PS}, cruciate retaining{CR}) of the cemented variant. This 510(k) also notifies the FDA of minor design update to the femoral component implant.

Materials: Cast Cobalt Chromium (CoCr) alloy (ASTM F75 and ISO 5832-4) for the femoral component and tibial baseplate, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for the femoral peg component and tibial baseplate variant, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for all variants of the patellar implants, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the All-poly tibial baseplate components and modular meniscal tibial inserts, and titanium nitride (TiN) for coating cemented femoral components.

The provided text describes a 510(k) premarket notification for a medical device, the "World Total Knee System," seeking clearance for a modification. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study for an AI/algorithm-based diagnostic or assistive device that would involve a test set, ground truth, and human reader performance.

Therefore, the input document does not contain the information necessary to describe acceptance criteria and a study that proves a device meets them in the context of an AI/algorithm-based diagnostic or assistive device.

The document outlines performance testing for implant components, such as:

• Cytotoxicity testing of TiN coating
• Bioburden testing of TiN coated implant
• Verification of coating pullout strength
• Wear testing for 5 million cycles
• Overlay analysis of femoral component dimensions
• Risk Analysis and Design Control Review

These tests are related to the material properties, manufacturing processes, and mechanical performance of the knee implant, not the diagnostic accuracy or effectiveness of an AI system.

Therefore, I cannot populate the requested table and answer the specific questions about an AI/algorithm study as the provided text pertains to a different type of medical device submission (a knee prosthesis with a material coating modification).

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The patient 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, 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.

Signature Orthopaedics' TriVerse Total Knee Replacement System components are indication only.

The TriVerse Total Knee System is a modular total knee replacement (TKR) system consisting of a femoral component, meniscal inserts, a locking bar for the meniscal insert, a patella and a tibial baseplate with a tibial post and bolt. The femoral component and meniscal insert locking bar is manufactured from cobalt chrome. The femoral component are available as posterior stabilise and cruciate retaining variants, while meniscal inserts are available as posterior stabilised, posterior stabilised plus, cruciate retaining and anterior stabilised variants. All variants of the meniscal inserts as well as the patella components are manufactured from Vitamin-E Stabilized UHMWPE (HXLPE). The tibial post component is available as an I-Beam or Finned keel variant. The tibial base plate, bolt and post components are manufactured from titanium alloy.

This document is a 510(k) premarket notification for a medical device called the "TriVerse Total Knee Replacement System." It is a submission to the FDA seeking clearance for market because the manufacturer believes it is substantially equivalent to legally marketed predicate devices.

The document does not describe AI/ML device performance or the study that proves an AI/ML meets acceptance criteria. Instead, it focuses on the substantial equivalence of materials, design, and performance testing for a physical orthopedic implant (knee replacement system) compared to existing predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The provided text does not contain information about:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes or data provenance for an AI/ML test set.
3. Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
4. Adjudication methods for an AI/ML test set.
5. MRMC comparative effectiveness studies for an AI/ML device, or human reader improvement with AI assistance.
6. Standalone performance of an AI/ML algorithm.
7. Types of ground truth used for AI/ML (expert consensus, pathology, outcomes data).
8. Sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

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The Signature Orthopaedics' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The TLC Unicompartmental Knee system is a modular knee system consisting of a femoral component, meniscal insert and a tibial baseplate. The femoral component is manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The tibial baseplate component is manufactured from titanium alloy and intended for use with bone cement. The meniscal insert is manufactured from UHMWPE.

This document is an FDA 510(k) clearance letter for a medical device (TLC Unicompartmental Knee System). It grants the manufacturer permission to market the device based on its substantial equivalence to previously cleared predicate devices.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria (e.g., performance metrics, sample sizes, ground truth establishment, or multi-reader studies).

The "Performance Testing" section lists the types of non-clinical tests performed (e.g., Range of motion analysis, Tibial plate fatigue testing), but it does not provide any specific acceptance criteria or the results of these tests. It merely states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the TLC UniKnee system is adequate for anticipated in-vivo use."

Therefore, I cannot extract the information required to populate the requested table and answer the questions directly from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed clinical or performance study demonstrating specific achievement of acceptance criteria.

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The patient 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 Orthopaedic's World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intented for cementless use by checking the package label.

The World Knee Total Knee System is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and meniscal inserts are available as posterior Stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. The tibial baseplate components covered in this 510(k) is made of Titanium as part of the cemented version. The patella components are available in a spherical or non-symmetrical designs.

The primary purpose of this Special 510(k) Device Modification to the World Knee System is to notify the FDA of the change in materials used to manufacture the tibial inserts (all variants (CR, PS and UC) of modular meniscal insert and all-poly tibial baseplate components) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE). This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537-11) for the femoral component, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for the tibial baseplate components, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for all variants of the patellar implants, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the Allpoly tibial baseplate components and modular meniscal tibial inserts.

This document is a 510(k) premarket notification from the FDA, approving the "World Knee Total Knee System". It primarily discusses the substantial equivalence of a modified device (incorporating Vitamin-E Stabilized, crosslinked UHMWPE for tibial inserts) to its previously cleared predicate devices.

Crucially, this document focuses on mechanical and material engineering evaluations, not on clinical performance studies involving human subjects or AI algorithms. Therefore, it does not contain information related to the acceptance criteria and study designs that would be relevant for devices that perform functions like image analysis or diagnostic assistance (e.g., AI-powered medical devices).

The acceptance criteria mentioned in this document are entirely related to the physical and material properties of the knee implant. The "study" proving the device meets these criteria is a series of engineering evaluations and material testing, performed in a lab setting, not a clinical trial with human subjects.

Therefore, many of the requested categories for AI/clinical study information (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, effect size, training set details) are not applicable to this type of device submission.

Here's an attempt to fill in the table and address the questions based solely on the provided text, recognizing that most of the requested information (especially for AI/clinical studies) is absent:

Acceptance Criteria and Device Performance (Based on Engineering Evaluations)

Study Details and Ground Truth Establishment

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of human clinical data or images. The "test set" here refers to material samples or components tested in a lab for physical and mechanical properties. The specific number of samples tested for each engineering evaluation (e.g., number of fatigue specimens, wear resistance samples) is not provided in this summary.
   • Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data collection. The data comes from laboratory testing and engineering evaluations performed by the manufacturer (Signature Orthopaedics Pty Ltd, Australia and Ireland).

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

   • Not applicable. Ground truth for material and mechanical properties is established through adherence to international and industry standards (e.g., ASTM, ISO) and the results of validated engineering tests. This is not a diagnostic device where human experts establish ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a study requiring adjudication of expert opinions. The "results" are quantitative measurements from standardized laboratory tests.

4. 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:

   • No. An MRMC study is completely irrelevant for this device. This is a knee implant, not a diagnostic imaging device or an AI application.

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

   • No. This is not an algorithm or AI device. "Performance" here refers to the device's physical and material integrity, not its diagnostic accuracy.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance is established by validated engineering and material testing standards (e.g., ASTM, ISO standards). These standards define the methodologies and acceptable ranges for properties like density, mechanical strength, wear resistance, and oxidation. The goal is to demonstrate that the new material/design is "substantially equivalent" or superior to existing, legally marketed predicates in terms of these physical characteristics.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

In summary, this FDA 510(k) approval document is focused on demonstrating the physical and mechanical equivalence of a new knee implant material and minor design updates to a previously cleared device, based on established engineering and material science principles, not on clinical performance or AI/diagnostic evaluation.

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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.

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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, World and Encore 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' Encore Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Encore Stem is straight and tapered with a rectangular cross-section. The stem has a polished distal tip to reduce fixation leading to proximal stress shielding. It features a titanium and hydroxyapatite plasma spray proximal coating below its resection line.

The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Encore Hip Stem." It concerns the regulatory approval process for a new hip implant. The document does not contain information about software or AI-based devices; therefore, it does not include acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set information as requested in the prompt.

The document discusses the substantial equivalence of the Encore Hip Stem to previously cleared predicate devices based on non-clinical performance testing and engineering evaluations. These tests are related to the mechanical properties and design of the physical implant, not the performance of an AI algorithm.

Specifically, the "Performance Testing" section states:
"Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Encore Hip Stem is adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:

• Range of Motion Testing
• Stem and Neck Fatigue FEA
• Stem and Neck Fatigue Testing
• Rim Impingement Analysis"

Therefore, I cannot provide the requested information from the given text as it pertains to a physical medical device, not an AI or software device.

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Signature Orthopaedics' Fusion Taper System is 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, hemi-arthroplasty, surface replacement, or total replacement
  Signature Orthopaedics' Fusion Taper System is intended for cementless fixation only.

The Fusion Taper System consists of modular femoral heads and taper sleeves. The Fusion Taper Sleeve is manufactured from Ti6Al4V as per ISO 5832-3. The Fusion Ceramic Head is manufactured from an alumina matrix as per ISO 6474-2. All Fusion Heads are intended for total hip arthroplasty. The Fusion Heads connect to the femoral stem via a Fusion Taper Sleeve which has a 12/14 inner taper and 16/18 outer taper. Signature Orthopaedics Fusion Taper System is indicated for use with Signature Ti6A14V femoral stems: TSI Stem (K102172), Origin Stem (K121297. K161155), Aria Stem (K121297), Remedy Stem (K133370), Spartan Stem (K192883), World Stem (K201278), and acetabular components: Logical Cup (K121297, K153131), Logical Liners (K121297), Logical 20deg Hooded Liners including lateralised variants (K153131), World Cup (K201278), and World Liner (K201278).

This document is a 510(k) summary for the Signature Orthopaedics Fusion Taper System, a hip replacement prosthesis. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not describe an AI/ML device or a study proving that such a device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to an AI/ML device from this document. The document describes a physical medical device (hip implant components) and its non-clinical testing for regulatory clearance.

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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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