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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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The porous components of the Genesis II Total Knee System are single use devices for use without cement. The devices are indicated for:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The porous coated components of the Genesis II Total Knee System are designed for use with existing tibial and patellar components and accessories of the Genesis II Total Knee Systems cleared via K951987 and K953274. The subject components are porous coated metal alloy devices.

The provided document is a 510(k) premarket notification for the Smith & Nephew, Inc. Genesis II Total Knee System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria for device performance.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document.

Here's a breakdown based on the information provided and the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of this 510(k) submission. Mechanical testing was performed, but specific sample sizes and data provenance for these internal tests are not detailed. The submission relies on a comparison to existing devices, not a new clinical trial with a "test set" of patients.

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

Not applicable. Ground truth in a clinical sense (e.g., diagnosis, outcome) is not established within this 510(k) submission. The "ground truth" for the submission is the regulatory acceptance of existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe any MRMC comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this 510(k) submission is the regulatory acceptance and established safety/effectiveness profile of predicate devices that were already legally marketed. The submission demonstrates that the new device is "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not a machine learning model. There is no "training set" in this context.

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

Not applicable (as above).

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Ask a specific question about this device