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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, 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. Smith & Nephew, Inc. Journey BCS Knee components are indicated for use only with cement and are single use devices.

This premarket notification seeks only to add kinematics claims for the existing Journey BCS Knee System cleared via K042515. No new total knee components being introduced as a result of this premarket notification.

The provided 510(k) summary for the Smith & Nephew JOURNEY BCS Knee System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/algorithm performance.

This document is a 510(k) premarket notification for a traditional medical device (knee implant), not an AI/ML-driven device. The focus of this submission is to add kinematics claims for an existing device, establishing substantial equivalence to a predicate device based on its physical properties and intended use, rather than algorithmic performance.

Therefore, the specific information about AI/algorithm acceptance criteria, performance studies, sample sizes, ground truth, and expert involvement for AI adjudication is not applicable and cannot be extracted from this document.

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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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