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MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory 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.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement.

Porous-Coated Total Knee Replacement Components are for use without bone cement.

The EVOLUTION® Total Knee System is for cemented use only.

The subject devices for this submission are all the predicate devices listed above, which consists of implant components used in knee arthroplasty. The only changes to the subject devices are updates to their labeling. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates. Testing is provided in this Traditional 510(k) that establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The basic design features are the following:

• Metal Femoral component manufactured from cobalt chrome alloy ●
• Femoral components available in porous and non porous versions
• Tibial inserts manufactured from UHMWPE
• Tibial bases manufactured from cobalt chrome alloy or titanium alloy ●
• Tibial bases available in porous and non porous versions ●
• All-poly patellae manufactured from UHMWPE
• Metal portion of metal backed patellae manufactured from titanium allov .

The provided text describes a 510(k) premarket notification for "MPO Total Knee Systems MR Labeling." This submission is solely for updating the labeling of existing total knee systems to include "MR Conditional" language and symbols, indicating their safety and compatibility in a magnetic resonance (MR) environment under specific conditions.

Therefore, the "device" in this context is not a new medical device whose performance is being evaluated in a clinical setting against acceptance criteria for diagnostic accuracy or treatment efficacy. Instead, the "device" is the existing knee implant system, and the study is focused on its MR compatibility, not its clinical performance or diagnostic capabilities.

Given this, the questions about acceptance criteria for device performance, sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable in their usual sense for a typical AI/diagnostic device submission.

However, I can extract information related to the MR compatibility testing:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Compatibility)

Since the standard format of diagnostic accuracy or treatment efficacy performance is not relevant here, the acceptance criteria are related to meeting specific MR safety standards. The document doesn't explicitly list a "table" of acceptance criteria but states that testing was conducted according to specific ASTM standards. The "performance" is that the devices met these standards to be deemed "MR Conditional."

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

• Sample Size: The document mentions "the worst case components and constructs" were evaluated for RF Heating, field interactions, and image artifacts. It does not provide a specific numerical sample size (e.g., number of individual implants tested). This is typical for bench testing where representative "worst-case" configurations are chosen rather than a large statistical sample of every single variation.
• Data Provenance: The testing was non-clinical (bench testing) and performed to recognized ASTM standards and FDA guidance. The "country of origin of the data" is not explicitly stated, but it would have been conducted by the manufacturer or a contracted lab to meet US FDA requirements. It is a prospective test in the sense that it was specifically conducted for this submission.

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

• Not Applicable. For MR compatibility bench testing, "ground truth" in the clinical diagnostic sense established by human experts is not relevant. The "ground truth" is determined by the physical measurements and observations made according to the defined test methods of the ASTM standards.

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

• Not Applicable. Adjudication methods are for interpretation of clinical data or images, not for physical bench testing results. The results are objective measurements against specified thresholds in the standards.

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:

• No. This is not an AI or diagnostic device. This is a knee implant system seeking MR conditional labeling. An MRMC study is not relevant.

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

• No. This is not an algorithm or AI device.

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

• Not Applicable. The "ground truth" for MR compatibility testing is the objective physical measurements and observations obtained by following validated test methods (e.g., temperature changes, deflection angles, artifact size) as defined by the ASTM standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

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