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The EVOLUTION® Cement Keel is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

2. Inflammatory degenerative joint disease, including rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques

The EVOLUTION® Cement Keels are for cemented use only.

MicroPort Orthopedics Inc. is seeking clearance to introduce the subject device, the EVOLUTION® Cement Keel, a line extension to the predicate EVOLUTION® Revision Tibial System cleared in K162026. It is a smaller, lower-profile size compared to the existing predicate Modular Keels, is manufactured from Ti6Al4V alloy conforming to ASTM F136, and is compatible with the same tapers as the predicate. The intended use of the subject modular keel is identical to the predicate, which is to provide optional rotational stability and added fixation to the compatible tibial bases.

The provided text is a U.S. FDA 510(k) summary for a medical device called the "EVOLUTION® Cement Keel." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/software devices.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable (N/A) because this submission is for a physical orthopedic implant seeking equivalence based on design, materials, and non-clinical testing, not a de novo or AI/ML-based device that requires extensive clinical validation against specific performance metrics using human experts and large datasets.

Here's the breakdown of the information provided in the context of your questions:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The core "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (EVOLUTION® Revision Tibial System, K162026) regarding indicators for use, technological characteristics, and safety/effectiveness. There are no quantitative performance metrics for the device itself listed as acceptance criteria in the way you might see for a diagnostic AI.
• Reported Device Performance: The "performance" is demonstrated through:
  • Dimensional comparison analysis: The subject device is a smaller, lower-profile size compared to the predicate modular keels.
  • Leveraging predicate test data: Axial and rotational distraction testing data from the predicate (K162026) were leveraged due to dimensional equivalency.
  • Material equivalency: Manufactured from Ti6Al4V alloy conforming to ASTM F136, which is equivalent to the predicate.
  • MRI safety evaluation: Per various ASTM standards and FDA guidances (ASTM F2182-19, F2182-11a, F2181-11, F2052-15, F2213-17, F2119-07, and FDA guidances on MR environment safety).
  • Biocompatibility, sterility, and shelf life: Justified based on equivalency to the predicate, as the subject implant materials are identical, and overall geometry/site of application are the same.

Table (Conceptual - as actual metrics are not provided in this type of submission):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (dimensional analysis) and leveraging previous test data from the predicate device, not a distinct "test set" of patient data or a clinical study for the new device.
• Data Provenance: Not applicable for a new clinical data set. The data leveraged is from non-clinical mechanical testing and material evaluations of previous iterations or the predicate device.

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. Ground truth as understood in the context of AI/ML or diagnostic device validation (e.g., expert consensus on medical images) is not relevant for this type of implant submission, which relies on engineering and materials science principles, and equivalency to previously cleared devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no clinical "test set" requiring adjudication of findings.

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. An MRMC study is relevant for AI-assisted diagnostic tools, not for a knee implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in the context of clinical ground truth for diagnostic purposes. The "ground truth" for this device's acceptance is its compliance with engineering standards, material specifications, and its demonstrated substantial equivalence through non-clinical testing and comparison to the predicate device.

8. The sample size for the training set

• Not applicable. No training set is involved as this is not an AI/ML or data-driven device.

9. How the ground truth for the training set was established

• Not applicable.

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