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The EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, 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® BIOFOAM® Tibial System implants are for cementless use only.

The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are for cemented use only.

A labeling change is taking place to include MR Conditional language and symbols to the implant components of the predicate device systems identified above. The changes only apply to the device labeling; therefore, the subject devices are identical to the predicate devices.

The non-clinical testing provided establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices include the following components and basic design features:

• . Metal femoral components manufactured from cobalt chrome alloy
• . Femoral revision accessories, including augments, manufactured from titanium alloy
• . CCK tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy
• . Tibial bases manufactured from titanium alloy available in porous and non-porous versions
• Tibial revision accessories, including keels, augments, stem extensions, and adapters, . manufactured from titanium alloy.
• . Patellae manufactured from UHMWPE and cobalt chrome alloy

The provided text is a 510(k) Summary for a medical device (EVOLUTION® Knee Systems – MR Labeling) and outlines nonclinical testing conducted to establish the device's conditional safety and compatibility in a magnetic resonance (MR) environment. It does not describe a study involving device performance against acceptance criteria in the usual sense of diagnostic accuracy or clinical outcomes, but rather safety and compatibility within an MR environment.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical or diagnostic performance are not applicable to this document. I will focus on what is provided regarding the MR safety testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria in a table format for MR safety. Instead, it refers to industry standards that define safe limits. The reported "performance" is that the device met these standards and showed no safety issues.

2. Sample size used for the test set and the data provenance

The document states, "The tests evaluated the worst case components and constructs for RF heating, field interactions, and image artifacts." It refers to "passive implants" but does not specify the exact number of components or constructs tested.

• Test set sample size: Not explicitly stated as a numerical count of individual devices, but "worst case components and constructs" were tested.
• Data provenance: Nonclinical testing performed according to U.S. FDA guidance and international standards (NEMA, ASTM). The location of the testing laboratory is not specified (e.g., country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The testing was nonclinical (MR safety testing), not involving human diagnostic interpretation or ground truth establishment by medical experts.

4. Adjudication method for the test set

This question is not applicable, as it was nonclinical testing, not involving human readers or interpretation requiring 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

There was no MRMC comparative effectiveness study described, as this document concerns the MR safety labeling of knee implant systems, not an AI-assisted diagnostic device.

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

This question is not applicable. The device is a knee implant system, not an algorithm.

7. The type of ground truth used

For an MR safety study, "ground truth" typically refers to the physical properties of the materials and their behavior in an MR field as measured by calibrated equipment following established standards. It's not expert consensus, pathology, or outcomes data in the clinical diagnostic sense. The ground truth is the quantitative measurements against the physical laws and established safety thresholds described by the ASTM and NEMA standards.

8. The sample size for the training set

This question is not applicable. This is not a machine learning or AI device that requires a training set.

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

This question is not applicable as there was no training set.

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