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The Arthrex iBalance UKA System components are for use in Unicompartmental knee arthroplasty as a result of:

· Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;

• · Correction of functional deformities;
• · Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

The tibial bearing is made from Vitamin E blended UHMWPE and is available in 6 sizes, ranging from 8-14mm in thickness. The design is symmetrical and may be used for either the medial or lateral compartment of the left or right knee in unicompartmental arthroplasty as part of the Arthrex iBalance UKA System.

This document describes the Arthrex iBalance UKA System Vitamin E Tibial Bearing, a medical device. The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria | Reported Device Performance |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| For Shear Interlock: The maximum moment force meets the acceptance criteria established in the predicate 510(k). This implies a quantitative or qualitative threshold for the maximum moment force the device can withstand without failure or unacceptable deformation, ensuring mechanical integrity. | Shear interlock testing was conducted on the proposed Vitamin E blended UHMWPE tibial bearing to demonstrate that the maximum moment force meets the acceptance criteria established in the predicate 510(k). (The specific numerical value of the acceptance criteria and the measured maximum moment force are not provided in this summary but are stated to have been met.) |
| For Pyrogenicity: The device meets pyrogen limit specifications as determined by Bacterial endotoxin per EP 2.6.14/USP . This indicates that the level of bacterial endotoxins (pyrogens) is below a predefined threshold, ensuring the device is safe for implantation and will not cause fever or other adverse pyrogenic reactions. | Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications. (The specific numerical pyrogen limit and the measured endotoxin levels are not provided but are stated to have been met.) |

Note: The document states that the Vitamin E material has been previously cleared under K153586 (Arthrex iBalance TKA System), implying that the material itself has met various other safety and performance criteria in that previous submission, such as biocompatibility, wear resistance, and mechanical properties. However, these specific criteria and their performance are not detailed in this 510(k) summary for the UKA system.

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

• Sample Size for Test Set: Not explicitly stated for either test. The description mentions "Shear interlock testing was conducted" and "Bacterial endotoxin per EP 2.6.14/USP was conducted," implying that a sufficient number of samples were tested to demonstrate compliance, but the exact number is not provided.
• Data Provenance: The studies were conducted by Arthrex, Inc. as part of a premarket notification to the FDA. The provenance of the data is internal to the manufacturer's testing processes to support substantial equivalence. The document does not specify country of origin for the data (beyond Arthrex being based in Naples, FL, USA), and the tests are inherently prospective for the purpose of demonstrating device performance.

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

Not applicable. The described tests (shear interlock and bacterial endotoxin) are objective physical and chemical tests, not subjective assessments requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. As noted above, these are objective physical and chemical tests.

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 implant, not an AI-powered diagnostic or decision support system.

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

Not applicable. This device is a physical knee implant.

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

For the shear interlock test, the "ground truth" is a predetermined acceptance criterion for maximum moment force, derived from regulatory standards, internal specifications, or benchmarks set by the predicate device. For the bacterial endotoxin test, the "ground truth" is the pyrogen limit specification defined by EP 2.6.14/USP standards. These are objective, measurable thresholds.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device performance tests like mechanical strength or pyrogenicity.

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

Not applicable. As there is no training set for these types of tests, there is no corresponding establishment of ground truth for a training set.

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