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The iBalance UKA Tibial Tray Implant is part of the iBalance UKA System, which is indicated 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.
  When used concurrently, the Arthrex iBalance UKA and PFJ systems, create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multi-compartmental knee arthroplasty in patients with:
• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful partial knee replacement or other procedure.
  The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee. These components are single use only and are intended for implantation with bone cement.

The proposed device is new tibial tray made of the same materials (CoCr) as the predicate. The proposed tibial tray is offered in six sizes (1-6) and available for the left-medial/right-lateral and right-medial/left-lateral compartments. The proposed device is designed for use with the cleared tibial bearing and femoral implants of the Arthrex iBalance UKA System.

This document is a 510(k) premarket notification for a medical device: the iBalance UKA Tibial Tray Implant. It is not a study demonstrating the performance of an AI/ML powered device. Therefore, the questions related to AI/ML device acceptance criteria and study methodologies, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, cannot be answered from the provided text.

The document primarily focuses on demonstrating the substantial equivalence of a physical medical implant (a knee joint component) to previously cleared predicate devices. The "Performance Data" section in the 510(k) summary refers to mechanical testing (Tensile testing, Finite Element Analysis), bacterial endotoxin testing, and MRI compatibility testing for the implant itself, not the performance of an AI/ML algorithm.

Therefore, the requested information for an AI/ML device's acceptance criteria and study will be stated as "Not applicable" or "Not provided" based on the content of this specific document.

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