(222 days)
The EVOLUTION® Revision Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.
The EVOLUTION® Revision Tibial System is being introduced to supplement MicroPort Orthopedics' knee product lines to provide revision surgery options with a cemented tibial base. The design features are summarized below:
- Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) .
- Available in 8 standard sizes, left and right ●
- . Available in 3 plus sizes, left and right
- Tibial base has holes for augment attachment screws
- System includes tibial base, modular keels, block augments, stem adapters (offset & extension), stem extensions (cemented & canal-filling cementless) and stem caps (metallic and poly)
The provided text is a 510(k) Summary for a medical device called the "EVOLUTION® Revision Tibial System." This document is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how training set ground truth was established) are not applicable or provided in this document as it pertains to a mechanical orthopedic implant, not an AI/software device that would involve such testing.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Evaluation Method) | Reported Device Performance |
|---|---|
| Bacterial Endotoxins (USP endotoxin limit of 20 EU/device) | Found to be less than the USP endotoxin limit of 20 EU/device (non-pyrogenicity established). |
| Fatigue Strength (Cantilever fatigue per ASTM F1800) | Concluded that the subject tibial base will have fatigue properties substantially equivalent to the predicate and is expected to perform as well or better than the predicate device in fatigue loading. |
| Fatigue Strength (3-point fatigue) | Concluded that the subject tibial base will have fatigue properties substantially equivalent to the predicate and is expected to perform as well or better than the predicate device in fatigue loading. |
| Static Evaluation (Axial distraction per ASTM F2009) | Concluded that the subject tibial base will perform as intended. |
| Static Evaluation (Rotational distraction) | Concluded that the subject tibial base will perform as intended. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing described is non-clinical (laboratory/mechanical testing of the implant itself) and does not involve human sample sizes or data provenance in the context of clinical trials or AI model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for mechanical device performance is established by engineering standards (e.g., ASTM F1800, ASTM F2009) and the physical properties of the materials and design, not by expert human interpretation in a medical imaging context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human-interpreted medical data, not for mechanical device testing.
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 algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing is based on established engineering standards and specifications (e.g., ASTM standards for fatigue and static evaluation), and the physical test results compared against those standards or the predicate device's established performance.
8. The sample size for the training set
Not applicable. This is a physical orthopedic implant, not a software/AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.