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510(k) Data Aggregation
(89 days)
The EVOLUTION® Revision CCK 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.
EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:
- Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
- . Available in 8 standard sizes, left and right
- Available in 2 plus sizes, left and right
- . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap
The provided text describes the MicroPort Orthopedics EVOLUTION® Revision CCK System, a knee joint prosthesis. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a diagnostic or AI/software device.
Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design features, materials, and non-clinical performance testing. The information provided is primarily related to mechanical and material performance rather than diagnostic accuracy or human performance with or without AI.
Therefore, I cannot fulfill all parts of your request as posed because the document is not an "acceptance criteria study" in the sense you are asking for. It is a regulatory submission demonstrating substantial equivalence.
Based on the provided text, I can extract information relevant to non-clinical performance testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for each test in a pass/fail format alongside numerical performance values. Instead, it describes comparative performance against a predicate device. The general "acceptance criteria" can be inferred as performing "as well as" or "greater than" the predicate device for various mechanical properties to demonstrate substantial equivalence.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Bacterial Endotoxin Limit (< 20 EU/device) | Less than the USP endotoxin limit of 20 EU/device. |
| Patellofemoral Contact Area (Perform as well as predicate) | Performed as well as the predicate K990030 implants. |
| Tibiofemoral Contact Area (Perform as well as predicate) | Possessed greater maximum contact area than the predicate K990030 implants. |
| Tibial Post Shear Fatigue (Perform as well as predicate) | Demonstrated greater fatigue resistance than the predicate K990030. |
| Taper Disassembly (Withstand typical in vivo forces) | Withstand typical in vivo disassociation forces as reported in peer-reviewed literature. |
| Taper Fatigue (Achieve values greater than predicate) | Achieved taper disassembly values greater than those of the predicate K162026 for Femoral constructs. |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical (laboratory) testing, not a test set derived from patient data. The "samples" would be the manufactured device components themselves, tested in a lab setting. The provenance is internal laboratory testing by MicroPort Orthopedics Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth.
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. This device is a physical knee prosthesis, not an AI/software device for interpretation.
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 "truth" for these non-clinical tests would be the measurement results against established engineering and material standards or comparisons to predicate devices' performance.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.
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