(90 days)
The porous components of the Genesis II Total Knee System are single use devices for use without cement. The devices are indicated for:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- 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 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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Capable of withstanding expected in vivo loading without failure. | "A review of the mechanical test data indicated that the porous components of the Genesis II Total Knee System are equivalent to devices currently available and are capable of withstanding expected in vivo loading without failure." |
| Design Features, Overall Indications, and Material Composition Equivalence: Similarity to existing components of Total Knee Systems distributed by Smith & Nephew. | "The substantial equivalence of the porous components of the Genesis II Total Knee System is substantiated by their similarities in design features, overall indications, and material composition as existing components of Total Knee Systems distributed by Smith & Nephew." |
| Safety and Effectiveness: Demonstrated by substantial equivalence to predicate devices (which are assumed to be safe and effective). | The FDA's substantial equivalence determination implies that the device is considered safe and effective for its stated indications for use, based on its similarity to legally marketed predicate devices. (This is a regulatory "acceptance" rather than a performance metric.) |
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).
§ 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.