(90 days)
The Active Unicompartmental Knee System is a modular unicompartmental system that is intended to resurface one diseased or damaged condyle of a knee where the other condyle remains intact. It is intended to be used only with bone cement in patients suffering from the following conditions:
- . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- Inflammatory degenerative joint disease excluding rheumatoid arthritis .
- Correction of functional deformity such as varus or valgus deformities. .
The Active Unicompartmental Knee System is a modular re-surfacing unicompartmental knee implant system, consisting of a metallic femoral component and a UHMWPE partial tibial component.
The provided text describes a 510(k) premarket notification for the "Active Unicompartmental Knee System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and material descriptions, rather than detailing a study that meets specific acceptance criteria for diagnostic or AI-driven performance.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text, as they pertain to clinical studies or performance evaluation of a diagnostic/AI device, which is not the subject of this 510(k) summary.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Mechanical Testing | FEA (Stress Testing) | Demonstrated similar performance characteristics to other unicompartmental knee designs. |
| Fatigue Testing (femoral component) | Demonstrated similar performance characteristics to other unicompartmental knee designs. | |
| Adhesion Testing (tibial component) | Demonstrated similar performance characteristics to other unicompartmental knee designs. | |
| Microstructural evaluation (femoral component) | Conducted and part of the overall demonstration of similar performance. | |
| Influence of heat treatment on CoCrMo components | Testing conducted to demonstrate similar performance. | |
| Effect of varying web height | Testing conducted to demonstrate similar performance. | |
| Material Conformance | Femoral Component Material | Cast cobalt/chrome/molybdenum alloy conforming to ASTM F75. |
| Tibial Component Material | Ultra High Molecular Weight Polyethylene meeting ASTM F468. Materials designed and used for surgical implant applications. | |
| Sterilization | Metal Components (gamma radiation) | 25 to 42 kGy (2.5 to 4.2 Mrad) gamma radiation per ISO 11137. |
| Polyethylene Components (Ethylene Oxide) | Ethylene Oxide per EN 550. | |
| Risk Analysis | Manufacturing Process Impact | Risk analysis and an independent report indicated the process is unlikely to impact the safety of the materials used. |
2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device (knee implant) submission, not a study involving a test set of data for a diagnostic device. The "testing" refers to mechanical and material property testing of the physical components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is compliance with material standards, successful mechanical testing, and demonstrating substantial equivalence to a predicate device.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.