(365 days)
The device is intended to reduce or relieve pain and restore function and motion to the knee joint.
The NexGen™ Complete Knee Solution, 9 mm articular surfaces are made of molded ultra-high molecular-weight polyethylene (UHMWPE). As with the MG II Knee, each articular surface is snapped into one of a series of the NexGen Knee tibial plates. The components are curved in both the frontal and sagittal planes. The posterior stabilized version having slightly more curvature in the anterior portion of the sagittal plane.
This document describes a 510(k) summary for the NexGen™ Complete Knee Solution, 9 mm Tibial Articular Surfaces. It's a submission for a medical device (knee implant components), not an AI/ML device, and therefore the requested information fields related to AI/ML study methodologies (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, etc.) are not applicable.
The document primarily focuses on demonstrating substantial equivalence to predicate devices, which is the standard pathway for certain medical devices.
Here's a breakdown of the relevant available information based on your request, highlighting why some fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Basic Geometric Shape Equivalence: The 9 mm tibial articular surfaces should have a similar basic geometric shape to the predicate device. | The 9 mm tibial articular surfaces have the same basic geometric shape as the predicate device (MG II® Total Knee System and Insall/Burstein® II Modular Knee System). |
| Intended Use Equivalence: The device's intended use should be similar to the predicate device. | The 9 mm tibial articular surfaces have the same intended use (reduce or relieve pain and restore function and motion to the knee joint) as the predicate device. |
| Material Equivalence: The device's material should be similar to the predicate device. | The 9 mm tibial articular surfaces are made of molded ultra-high molecular-weight polyethylene (UHMWPE), consistent with the material of the predicate device (implied, as this is a standard material for such components). |
| Safety and Effectiveness (Clinical Equivalence): The device is expected to achieve satisfactory clinical results, comparable to the predicate device. | "Numerous studies reported in the literature for the predicate devices indicate that satisfactory results have been obtained through the use of 9 mm tibial articular surfaces." This implicitly supports the safety and effectiveness of the new device by demonstrating equivalence to a device with a known safety and effectiveness profile. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This is a medical device submission based on substantial equivalence to predicate devices, not an AI/ML algorithm requiring a specific test set for performance evaluation. The "studies" mentioned refer to existing literature on the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. Ground truth, in the context of AI/ML, is not relevant here. The "evidence" comes from long-standing clinical use of similar devices.
4. Adjudication Method for the Test Set
- Not Applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for this device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Clinical Outcomes/Established Performance of Predicate Devices (Implied): The "ground truth" or basis for acceptance is derived from the long-term, satisfactory clinical performance reported in the literature for the predicate MG II® Total Knee System and Insall/Burstein® II Modular Knee System, demonstrating the safety and effectiveness of similar 9 mm tibial articular surfaces.
8. The Sample Size for the Training Set
- Not Applicable. This conceptual framework of "training set" is for AI/ML algorithms, not for physical medical device submissions like this one.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.