(28 days)
General Indications:
The LinkSymphoKnee is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions.
This device is intended for cemented use only unless a cementless modular stem is indicated for use.
Indications:
- Primary degenerative arthritis / osteoarthritis
- Secondary arthritis resulting from rheumatoid arthritis
- Fracture
The LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is available in cPE and E-Dur. In cases of good joint stability, where the ligaments and capsule are intact the FB UC version is available. This configuration is provided for PCL retaining joint reconstruction or if the posterior cruciate ligament is sacrificed.
The Fixed Bearing Ultracongruent (FB UC) Articulating Surface is compatible with the already cleared LinkSymphoKnee (K202924). The LinkSymphoKnee is available in multiple versions with different applications, characteristics, and materials.
This document does not describe an AI/ML device but rather a knee joint prosthetic. Therefore, many of the requested fields and information are not relevant or present in the provided text.
Based on the information provided for the LinkSymphoKnee - Fixed Bearing Ultracongruent (FB UC) Articulating Surface:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (implied from testing) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Range of Motion (comparable to predicate) | Accepted (suitable for intended purpose) |
| Wear (meeting ISO 14243-1 standards) | Accepted (suitable for intended purpose) | |
| Particle analysis (meeting ISO 17853 and ASTM F1877 standards) | Accepted (suitable for intended purpose) | |
| Constraint (meeting ASTM F1223-20 standards) | Accepted (suitable for intended purpose) | |
| Contact area/stress (comparable to predicate) | Accepted (suitable for intended purpose) | |
| Design & Materials | Similar design to predicate devices | Similar to predicate devices |
| Similar materials to predicate devices | Similar to predicate devices | |
| Indications for Use | Similar indications to predicate devices | Similar to predicate devices |
| Safety | Mechanical safety comparable to predicate devices | Comparable to predicate devices |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable/Provided. The performance testing described is for a medical device (knee implant), not an AI/ML system. The testing likely involved mechanical testing of device samples.
- Data provenance: Not explicitly stated, but the testing was non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/ML system requiring expert-established ground truth. Performance was evaluated through non-clinical mechanical testing standards.
4. Adjudication method for the test set:
- Not applicable. Performance was evaluated through non-clinical mechanical testing standards, not expert adjudication.
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. This is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-driven algorithm.
7. The type of ground truth used:
- For mechanical performance testing, the "ground truth" would be established physical and engineering standards (e.g., ISO 14243-1, ISO 17853, ASTM F1877, ASTM F1223-20) and benchmark data from predicate devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML system, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. There is no 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.