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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 Arthrex iBalance BiCompartmental Arthroplasty System is comprised of a unicompartmental implant system (Arthrex iBalance UKA) and a patellofemoral implant system (Arthrex iBalance PFJ). The Arthrex iBalance UKA and Arthrex iBalance PFJ systems may be used in conjunction to create a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee.

The provided document is a 510(k) premarket notification for the Arthrex iBalance BiCompartmental Arthroplasty System. It states that the device is substantially equivalent to legally marketed predicate devices and does not describe actual acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of device performance metrics commonly associated with AI/software devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, size ranges, materials, and biomechanical testing, rather than reporting on specific performance metrics against an acceptance criterion in a clinical study.

Here's a breakdown of the requested information based on the provided text, and where it is not applicable or not found in this specific document:

1. Table of Acceptance Criteria and the Reported Device Performance

This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide a table of reported device performance against such metrics. The clearance is based on substantial equivalence.

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 the test set: Not applicable/not provided. The document states, "Clinical data and conclusions are not needed for this device." The evaluation was based on biomechanical testing and comparison to predicates, not a clinical test set with patient data.
• Data provenance: Not applicable/not provided for a clinical test set. The biomechanical testing would have been conducted in a lab setting.

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/not provided. No clinical test set or ground truth established by experts is mentioned for this 510(k) submission.

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

Not applicable/not provided. No clinical test set requiring adjudication is mentioned.

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/not provided. This is a medical device (knee arthroplasty system) and not an AI or imaging diagnostic software. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission.

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

Not applicable/not provided. This is a physical medical implant device, not a standalone algorithm.

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

Not applicable/not provided. For this type of device, "ground truth" would typically relate to mechanical performance or biocompatibility. The document mentions "biomechanical testing data" which demonstrated the "system worked well."

8. The sample size for the training set

Not applicable/not provided. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable/not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this document):

The "study" or justification for clearance in this 510(k) submission relies on substantial equivalence to existing predicate devices. The document explicitly states:

• "The submitted biomechanical testing data demonstrated the system worked well and the two systems did not impinge on one another."
• "Mechanical data is unchanged from the original clearances; no further mechanical testing is necessary to demonstrate that the iBalance BiCompartmental Arthroplasty System is adequate for its intended use."
• "Clinical data and conclusions are not needed for this device."

Therefore, the device meets its "acceptance criteria" by demonstrating that it is as safe and effective as previously cleared devices based on its intended use, design, materials, and biomechanical performance, without the need for new clinical data or specific quantitative performance metrics against acceptance thresholds in a clinical study.

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