(84 days)
The Hybrid Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- post-traumatic arthritis; .
- degenerative arthritis; and ●
- failed osteotomies, hemiarthroplasties; and unicompartmental replacement .
These indications will be used for the Hybrid Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Hybrid Knee Femoral Components are single use only and are intended for implantation only with bone cement.
The Smith & Nephew Hybrid Knee Femoral Components are designed for use with tibial components of the Genesis I Unicondylar Knee System and patellar components of the Genesis II Total Knee System. The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint.
Acceptance Criteria and Study for Smith & Nephew Hybrid Knee Femoral Components
Based on the provided document, the Smith & Nephew Hybrid Knee Femoral Components were cleared through a 510(k) premarket notification process, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria against a defined clinical outcome. Therefore, the "acceptance criteria" here refers to the demonstration of equivalence through mechanical testing and comparison of design, indications, and materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Capability of withstanding expected in vivo loading without failure. Assessed against "devices currently used clinically." | "A review of the mechanical test data indicated that the Smith & Nephew Hybrid Knee Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." |
| Design Features | Similarities in design features to existing components of the Genesis I Unicondylar Knee System, Genesis II Total Knee System, and other commercially available patellofemoral joint prostheses. | "The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in design features... as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses." |
| Overall Indications | Similarities in overall indications to existing components of the Genesis I Unicondylar Knee System, Genesis II Total Knee System, and other commercially available patellofemoral joint prostheses. Also, specific indications for use as listed. | "The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in... overall indications... as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses." |
Specific Indications for Use listed: post-traumatic arthritis; degenerative arthritis; failed osteotomies, hemiarthroplasties; and unicompartmental replacement, affecting the medial condyle and patellofemoral regions. |
| Material Composition | Similarities in material composition to existing components of the Genesis I Unicondylar Knee System, Genesis II Total Knee System, and other commercially available patellofemoral joint prostheses. | "The substantial equivalence of the Smith & Nephew Hybrid Knee Femoral Components is substantiated by its similarities in... material composition as existing components of the Genesis I Unicondylar Knee System and Genesis II Total Knee Systems distributed by Smith & Nephew, Inc., as well as other commercially available patellofemoral joint prostheses." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for evaluating device performance. The assessment relies on mechanical test data and a comparison to existing devices. Therefore:
- Sample size for test set: Not explicitly stated for mechanical testing, but general practice for such devices would involve multiple samples for various mechanical tests (e.g., fatigue, static strength).
- Data provenance: Mechanical test data would typically be generated in a laboratory setting. Clinical "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable here as a clinical study was not conducted to establish performance for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes a 510(k) submission relying on substantial equivalence, not a clinical study requiring expert ground truth establishment for a test set. The "ground truth" for mechanical performance is based on established engineering principles and benchmarks from predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not conducted or mentioned in the provided document. The submission relies on mechanical equivalence and comparison to predicate devices, not on a study demonstrating improved human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable as the device is a physical knee femoral component, not an algorithm or AI system.
7. Type of Ground Truth Used
For the mechanical performance, the "ground truth" can be considered as:
- Established engineering standards and biomechanical principles: For evaluating the ability to withstand expected in vivo loading.
- Performance of predicate legally marketed devices: The document states the mechanical data indicated equivalence to "devices currently used clinically," implying comparison to the established performance of existing predicate devices.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical implant, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical implant, not a machine learning model requiring a training set.
§ 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.