(23 days)
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 Legion Porous Primary femoral components are indicated for use without bone cement and are single use devices.
Subject of this premarket notification are the Legion Porous Primary femoral components, which are intended for uncemented applications. The Legion Porous Primary femoral components are offered in cruciate retaining (C/R) and posterior stabilizing (P/S) designs, both manufactured from Cobalt Chrome alloy material. The femoral components are available in sizes 1 through 8 in right and left configurations. The femoral components will porous coated using a -45/+60 titanjum bead layer conforming to ASTM F67.
This document is a 510(k) summary for the Smith & Nephew Legion Porous Primary Femoral Component. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission does not typically include detailed studies with acceptance criteria and device performance metrics in the same way a PMA (Premarket Approval) application would.
Instead, substantial equivalence is generally established through comparisons to legally marketed predicate devices, focusing on design, materials, indications for use, and technological characteristics. Performance data, if included, is often limited to bench testing or material property comparisons rather than clinical studies with human readers or specific performance metrics like sensitivity/specificity.
Therefore, many of the requested categories in your prompt will not be found in this 510(k) submission.
Here's an analysis based on the provided text, indicating where information is present or not applicable (N/A) for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable to a 510(k) summary in the way described. A 510(k) aims to demonstrate substantial equivalence to a predicate device, rather than meeting specific performance acceptance criteria from a clinical trial. The "performance" here refers to demonstrating that the new device is as safe and effective as existing models through design similarities, material properties, and intended use.
The document states: "The overall design of the Legion Porous Primary Femoral Component is based on the existing Genesis II Knee System femoral components cleared under the premarket notifications listed below". This indicates that the established performance of the predicate devices implicitly serves as the "acceptance criteria" for the new device – if it's substantially equivalent in design and materials, it's assumed to perform similarly.
The document mentions that the femoral components will be "porous coated using a -45/+60 titanium bead layer conforming to ASTM F67". This is a material specification used to demonstrate equivalence in manufacturing and material properties, rather than a clinical performance metric.
2. Sample Size Used for the Test Set and Data Provenance
N/A. This 510(k) summary does not describe a clinical test set or study with human subjects for performance evaluation. It relies on demonstrating substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
N/A. As there is no clinical test set described in this 510(k) summary, there were no experts used to establish ground truth for such a set.
4. Adjudication Method for the Test Set
N/A. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This submission does not describe an MRMC comparative effectiveness study to assess improvement with AI assistance (as this is not an AI device).
6. Standalone Performance Study (Algorithm Only)
N/A. This is a medical device (knee implant), not an algorithm or AI system.
7. Type of Ground Truth Used
N/A. No clinical study for performance evaluation described. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices to which it is compared.
8. Sample Size for the Training Set
N/A. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
N/A. No training set as it is not an AI/ML algorithm.
Summary of 510(k) Approach for this Device:
The core of this 510(k) submission is to establish Substantial Equivalence (SE) to legally marketed predicate devices. The document directly states: "The overall design of the Legion Porous Primary Femoral Component is based on the existing Genesis II Knee System femoral components cleared under the premarket notifications listed below".
The predicate devices mentioned are:
- Genesis II Knee System (cemented use)
- Genesis II Knee System (uncemented use)
The demonstration of substantial equivalence is likely achieved through:
- Comparison of Indications for Use: The current device's indications are consistent with the predicate devices.
- Comparison of Technological Characteristics: This includes material (Cobalt Chrome alloy, porous coated with titanium bead layer conforming to ASTM F67), design (CR and PS designs, sizes 1-8), and overall function.
- Non-clinical (bench) testing: While not detailed in this summary, such submissions typically include non-clinical performance data (e.g., mechanical testing, wear testing, fatigue testing) to demonstrate that the new device performs as intended and is comparable to the predicate devices under simulated use conditions.
Conclusion:
This 510(k) summary for the Legion Porous Primary Femoral Component does not contain the detailed information about acceptance criteria, clinical study designs, human reader performance, or ground truth establishment that would be found in a Premarket Approval (PMA) application or a submission for an AI-powered diagnostic device. Its purpose is to demonstrate substantial equivalence to existing, legally marketed knee prosthesis systems, rather than to prove performance against novel acceptance criteria from a clinical trial.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.