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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  This device is intended for cemented use only.

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

This document describes the non-clinical performance testing for the Zimmer® Persona™ Personalized Knee System, a semi-constrained modular knee prosthesis. Since this is a medical device (knee implant) rather than an AI/software device, many of the requested fields (multi-reader multi-case study, ground truth establishment, training set details) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly demonstrating "sufficient" or "adequate" strength/wear/constraint, or being "comparable" to predicate devices. The "Test Results" column describes how the device performance met these implicit criteria.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for each mechanical test. These "tests" are non-clinical (laboratory-based mechanical and wear simulations) rather than using patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as these are not studies involving human subjects or patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a medical device, not an AI/software device that requires expert ground truth for its performance evaluation. The "ground truth" for these tests is based on established engineering principles, industry standards (e.g., ISO 14243), and comparison to predicate devices, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical mechanical testing, not a clinical study requiring human adjudication.

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 physical medical device (knee implant), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. As this is not an AI/software device, the concept of a "standalone algorithm" is not relevant. The device itself (the knee implant) is the "standalone" item being tested in these non-clinical performance studies.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance tests is based on:

• Industry Standards: For instance, wear testing was conducted "Under Load and Motion Curves From the ISO 14243 Standard."
• Established Engineering Principles: Tests like fatigue, static shear strength, and contact mechanics rely on well-known engineering material and biomechanical principles.
• Predicate Device Performance: Many tests established comparability to existing, legally marketed predicate devices (e.g., NexGen articular surfaces, NexGen predicate devices). The performance of these predicate devices, which have a history of safe and effective use, serves as a benchmark or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device (knee implant), not a machine learning or AI algorithm. There is no concept of a "training set" for the device itself.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• B. Failed osteotomy or unicompartmental replacements.
• C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• D. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since the mid-1990's.

The CKS has been designed to replicate the natural anatomy of the knee in order to restore knee function. It has been developed to preserve and utilize healthy ligamentous structures. For cases where the soft tissues are not functional, the PCL substituting tibial inserts or the posterior stabilized system are available for increased stability.

The CKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The CKS can be used for total knee replacement with posterior cruciate ligament (PCL) retaining or substituting.

The femoral components are provided in left and right side versions and are designed to replicate natural kinematic motion between the femur, tibia and patella. The Consensus femoral component is designed to provide uniform contact zones in the coronal plane throughout the range of motion when the knee is properly aligned. The femoral component is also designed with a large distal radius to optimize contact areas and reduce contact stress. The trochlear groove in the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint.

The CKS metallic components are available in non-porous and porous coated variants for cemented use and in a porous coated (CoCr beads with Titanium) version for uncemented use.

This document describes the non-clinical performance data for the Consensus® Knee System Line Extensions. The data focuses on material properties and mechanical performance rather than AI or human reader studies.

Here's the breakdown of the requested information based on the provided text, with an emphasis on addressing the relevant sections and noting where information is not applicable:

1. A table of acceptance criteria and the reported device performance

The remaining information requested is largely not applicable (N/A) to this specific type of device and study. The provided document describes a 510(k) submission for line extensions of a knee prosthetic system, focusing on non-clinical performance data related to material properties, mechanical strength, and design conformity. It does not involve any AI, diagnostic imaging, or human reader performance studies.

Here's an explanation for each point:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a "sample size" in the context of clinical trials or data sets for an AI model. For mechanical testing, the number of samples tested for each specification is not explicitly stated, although it's implied that multiple samples were tested to achieve "Avg. mass loss," etc.
• Data Provenance: N/A. This is non-clinical mechanical and material testing, not data collected from human subjects or from a specific geographical origin. It's likely laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A. This study does not involve expert evaluation for establishing ground truth as it's not a diagnostic or AI-based device. The "ground truth" here refers to the physical properties and performance metrics measured in a lab setting according to established standards.

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

• N/A. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the case here.

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

• N/A. This is not an AI-assisted diagnostic or interpretation device.

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

• N/A. This device does not involve any algorithm or AI requiring standalone performance evaluation.

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

• The "ground truth" for this device's performance is based on objective engineering and material science standards and measurements. This includes:
  • ASTM standards (e.g., F746 & G61 for corrosion).
  • Pre-defined mechanical thresholds (e.g., static tensile strength > 20 MPa, fatigue strength > 10 million cycles).
  • Physical design specifications (e.g., "Identical articulating surface," "Insert thickness must be >6mm").

8. The sample size for the training set

• N/A. There is no AI or machine learning model, so no training set is applicable.

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

• N/A. As there is no training set, this question is not applicable.

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The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• B. Failed osteotomy or unicompartmental replacements.
• C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

The Consensus Total Knee System (CKS) is a primary fixed-bearing total knee system that has been on the market since 1990's.

The CKS has been designed to replicate the natural anatomy of the knee in order to restore knee function. It has been developed to preserve and utilize healthy ligamentous structures. For cases where the soft tissues are not functional, the PCL substituting tibial inserts or the posterior stabilized system are available for increased stability.

The CKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The CKS can be used for total knee replacement with posterior cruciate ligament (PCL) retaining or substituting.

The femoral components are provided in left and right side versions and are designed to replicate natural kinematic motion between the femur, tibia and patella. The Consensus femoral component is designed to provide uniform contact zones in the coronal plane throughout the range of motion when the knee is properly aligned. The femoral component is also designed with a large distal radius to optimize contact areas and reduce contact stress. The trochlear groove in the femur is designed to allow the load from the patella to be evenly distributed on the femur with adequate lateral constraint.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

Acceptance Criteria and Device Performance for Consensus® Knee System (K102927)

This submission (K102927) is primarily to expand the indications for the already cleared Consensus® Knee System (CKS) porous-coated components to allow for uncemented use. The non-clinical performance data provided specifically addresses the porous coating's mechanical and chemical properties, demonstrating its suitability for this expanded use.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes a clear table outlining the specifications, acceptance criteria, and verification results for the modified surface (porous CoCr bead with Ti coating).

Note: For microstructure and abrasion, the "Acceptance Criteria" are listed as "N/A" in the table, indicating these are descriptive measurements rather than pass/fail thresholds in this summary. However, the reported values are provided as verification results. For corrosion, the results for both CoCr beads and Ti Coated CoCr Beads demonstrate a comparable or improved resistance against the breakdown potential.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance data which typically involves laboratory testing of materials and components, not clinical data from patients. Therefore, terms like "test set" in the context of patient data, "country of origin of the data," or "retrospective/prospective" studies are not applicable here.

The sample sizes for the mechanical and corrosion tests are not explicitly stated in this summary. It's common in such submissions for the detailed test reports (which would include sample sizes, testing methodologies, and raw data) to be referenced but not fully reproduced in the 510(k) summary. These tests are performed on material coupons or device components in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to this submission. The "test set" here refers to material samples or device components tested in a lab. The "ground truth" is established by direct physical and chemical measurements (e.g., measuring dimensions, applying forces, assessing corrosion) using standardized test methods (like ASTM standards mentioned). Therefore, human expert consensus on image interpretation or clinical outcomes is not relevant for this type of non-clinical data.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth, typically in clinical studies or image review. Since this involves non-clinical laboratory testing, there is no human adjudication process of this nature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study assesses how human readers' diagnostic performance changes with and without AI assistance, which is irrelevant for a submission concerning the material properties and expanded uncemented use of a knee implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm performance study was done. This typically refers to the performance of an AI algorithm on its own. The Consensus® Knee System is a medical device (a knee implant), not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this non-clinical performance data is direct physical and chemical measurement against predefined specifications and ASTM standards. This includes:

• Physical dimensions and morphology (e.g., bead neck diameter, pore size, coating thickness).
• Electrochemical properties (e.g., critical potential, breakdown potential for corrosion resistance).
• Mechanical properties (e.g., static tensile strength, static shear strength, shear fatigue strength, rotating beam fatigue strength, mass and thickness loss from abrasion).

8. Sample Size for the Training Set

This question is not applicable. There is no AI model or algorithm being trained within the scope of this 510(k) submission. The data presented are for validating the material properties of the porous coating.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set mentioned or implied in the context of this device submission.

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Gender Solutions" Natural-Knee® Flex System:

• Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
• Components without CST are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

The Gender Solutions Natural-Knee Flex (N-K Flex) components are semiconstrained, nonlinked condylar knee prosthesis that are designed to have a maximum active flexion of 155 degrees. The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.

The provided text describes a 510(k) premarket notification for a medical device, the Gender Solutions™ Natural-Knee® Flex System. This is a type of knee replacement prosthesis. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than conducting a de novo study involving novel performance evaluation criteria for an AI/ML powered device.

Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

This submission is for a knee prosthesis, not an AI/ML powered diagnostic or prognostic device. As such, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or AUC, but rather the demonstration of substantial equivalence to existing, legally marketed predicate devices.

The primary "performance" assessed is mechanical equivalence to the predicate device.

Study Details (Applicability to AI/ML Device Evaluation)

Given that this is a 510(k) submission for a traditional medical device (knee prosthesis), the following points related to AI/ML device evaluation are not applicable and are not discussed in the provided text:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The study involves mechanical testing of physical implants, not a "test set" of data for algorithm evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of a "ground truth" derived from expert consensus in the context of mechanical testing for a knee prosthesis.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic or prognostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth for this device is its mechanical properties matching a predicate device.
7. The sample size for the training set: Not applicable. No "training set" in the AI/ML sense.
8. How the ground truth for the training set was established: Not applicable.

Summary of Performance Data from the Submission

The document states:

• Non-Clinical Performance and Conclusions: "Mechanical testing of the subject devices demonstrates that they are substantially equivalent to the predicate devices."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for these devices."

This indicates that the safety and effectiveness of the Gender Solutions™ Natural-Knee® Flex System were established through non-clinical mechanical testing, demonstrating its equivalence to predicate devices that have already established safety and efficacy. No human clinical trials or data interpretation studies were required or performed for this particular 510(k) submission. The modifications from the predicate device were described as "dimensional and material modifications," which implies that the fundamental design and function were maintained, justifying the reliance on mechanical testing for substantial equivalence.

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.

The Smith & Nephew, Inc. Gender Knee Systems are the existing Smith & Nephew, Inc. Genesis II, Legion, and Journey BCS Knee Systems. This premarket notification seeks only to add gender-related claims for these existing total knee systems previously cleared by FDA marketed by Smith & Nephew. No new total knee components being introduced as a result of this premarket notification.

This document is a 510(k) Pre-market Notification for the Smith & Nephew, Inc. Gender Knee Systems. It is a regulatory submission to the FDA seeking to add gender-related claims to existing total knee replacement systems.

Based on the provided text, the device is being cleared based on substantial equivalence to previously marketed predicate devices, not on a new study demonstrating its efficacy or performance against specific acceptance criteria. This type of submission (510(k)) does not typically involve the rigorous clinical trial evidence that would include specific acceptance criteria and a detailed study report as requested in your prompt.

Therefore, many of the requested elements are not present in this type of regulatory document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document does not describe specific performance-based acceptance criteria for the "Gender Knee Systems" or report performance results against such criteria. The submission is for "gender-related claims" for existing devices, relying on substantial equivalence to predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No new clinical testing or "test set" is described for this 510(k) submission. The clearance is based on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No "test set" requiring ground truth establishment by experts is described in this regulatory submission.

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

• Cannot be provided. No "test set" and thus no adjudication method is described.

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

• Cannot be provided. This document is about a knee implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable or mentioned.

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

• Cannot be provided. This document is about a knee implant, not an algorithm, so this concept is not applicable.

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

• Cannot be provided. As there's no new study or "test set" described, there's no mention of ground truth types.

8. The sample size for the training set

• Cannot be provided. This is not a machine learning/AI device, and no "training set" is relevant or mentioned.

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

• Cannot be provided. As above, a training set and its ground truth establishment are not applicable to this device or its regulatory pathway.

Summary of what is known based on the provided text:

• Device Name: Smith & Nephew, Inc. Gender Knee Systems (based on existing Genesis II, Legion, and Journey BCS Knee Systems)
• Regulatory Pathway: 510(k) Premarket Notification
• Purpose of Submission: To add "gender-related claims" to existing, previously cleared total knee systems.
• Basis for Clearance: Substantial Equivalence to predicate devices, specifically:
  • Zimmer NexGen Knee Gender Solutions Female (GSF) Femoral Components (K060370)
  • Zimmer Gender Solutions Natural-Knee Flex System (K070214)
  • Stryker Triathlon Total Knee System (K053514)
• Intended Use: Standard total knee replacement indications for rheumatoid arthritis, post-traumatic arthritis, degenerative arthritis, and failed previous surgeries, tailored to posterior stabilized or constrained knee systems, in cemented or uncemented applications.

In essence, this document demonstrates that the FDA reviewed the application and determined that the "Gender Knee Systems" with the added gender-related claims are substantially equivalent to other legally marketed predicate devices, meaning no new performance acceptance criteria or detailed study results are included within this specific 510(k) summary.

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