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510(k) Data Aggregation
(29 days)
Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicoment, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery. where the anterior cruciate ligaments are 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 incompetent.
The Smith & Nephew LEGION Inserts with JRNY Lock are single use devices.
The subject devices of this Special 510(k) are the LEGION Inserts with JRNY Lock. The subject LEGION Inserts with JRNY Lock are tibia insert components, and a line extension of the LEGION Articular Inserts cleared under premarket notification K071071 (S.E. 09/16/2007). The subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the LEGION CR High Flex and CR Deep Dish Inserts with JRNY Lock, cleared under premarket notifications K200407 (S.E. 3/13/2020) respectively.
The subject LEGION Inserts with JRNY Lock have a size range of 1-2, 3-4, 5-6, 7-8 with thicknesses of 9, 10, 11, 12, 13, 15, 18, 21, 25, 30mm, and come in cruciate-retaining standard (CR STD), posterior-stabilizing standard (PS STD), posterior-stabilizing high flexion (PS HF) and posterior-stabilizing Constrained (PS Constrained) varieties.
The subject LEGION PS Constrained, LEGION PS STD, and LEGION CR STD Inserts with JRNY Lock are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE) and the subject LEGION PS HF Inserts with JRNY Lock are manufactured from 7.5MRad Crosslinked Polyethylene (XLPE) conforming to ASTM F648 (FDA Recognition Number 8-569) and ISO 5834-2 (FDA Recognition Number 8-514).
This FDA 510(k) premarket notification describes a medical device, specifically knee joint components (LEGION Inserts with JRNY Lock), and as such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance is not applicable to this document.
This document outlines the regulatory pathway for a conventional medical device modification, demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing and a review of technological characteristics, rather than AI/ML algorithm performance.
Therefore, many of the requested fields for AI/ML performance evaluation are not present or relevant in the provided text. I will address the relevant sections based on the information available and indicate where information is not applicable.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document describes a Special 510(k) submission for a modified medical device, the LEGION Inserts with JRNY Lock. The "acceptance criteria" in this context refer to demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical performance and a review of technological characteristics, rather than the performance metrics of an AI/ML algorithm.
The "study that proves the device meets the acceptance criteria" for this conventional device involves performance testing to show that the modified device's mechanical characteristics are equivalent to the predicate devices and that the modification does not raise new safety or effectiveness concerns.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a mechanical device, not an AI/ML algorithm, the acceptance criteria are not in the form of sensitivity, specificity, or AUC. Instead, they relate to mechanical properties. The document states a "review of the leveraged mechanical data indicates that the subject LEGION Inserts with JRNY Lock are substantially equivalent to one or more of the previously cleared predicate devices."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | Subject devices are substantially equivalent to predicate devices based on a review of leveraged mechanical data. No new issues related to safety and effectiveness identified. |
| Range of Motion and Constraint | Reviewed and found to be substantially equivalent to predicate devices. |
| Tibiofemoral Contact Area Analysis | Reviewed and found to be substantially equivalent to predicate devices. |
| Component Interlock Strength Testing | Reviewed and found to be substantially equivalent to predicate devices. |
| Bacterial Endotoxin | Testing completed and met acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated numerically. The "test set" refers to the specific LEGION Inserts with JRNY Lock samples that underwent mechanical and endotoxin testing. This would typically involve a statistically relevant number of samples for each test, but the exact count is not detailed in the summary.
- Data Provenance: The document implies the data was generated internally by Smith & Nephew, Inc. as part of their premarket notification. This would be prospective data generation for the purpose of regulatory submission. The country of origin for the testing itself is not specified but is presumably conducted at facilities associated with the submitter, Smith & Nephew, Inc. (Cordova, Tennessee, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. For a mechanical device, "ground truth" established by experts in the context of test set labeling (e.g., radiologists for images) is not relevant. The "ground truth" for mechanical testing would be defined by established engineering standards and physical measurements. The evaluation of test results would be conducted by qualified engineers and scientists.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of data, which is not relevant for mechanical performance testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is for evaluating human performance with and without AI assistance, which is not relevant for this mechanical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This device is a physical knee implant component, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Standards and Physical Measurements: For mechanical performance tests (Range of Motion, Constraint, Tibiofemoral Contact Area Analysis, Component Interlock Strength Testing), the "ground truth" is based on established engineering principles, material properties, and relevant ASTM/ISO standards. For bacterial endotoxin testing, the "ground truth" is defined by the acceptable limits set in FDA guidance and ANSI/AAMI ST72.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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