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The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:

• Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis:
• Post-traumatic loss of knee joint configuration and function;
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability:
• Revisions of previous unsuccessful knee replacement or other procedure.

Additional indications for posteriorly stabilization components:

• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.

These devices are single use only and are intended for implantation with the exception of porous coated femoral components which can be used cemented (biological fixation).

The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions, as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Tibial bearing components are offered in PS, CR and CR Plus configurations.

The proposed Arthrex iBalance® TKA System line extension of this submission adds Vitamin E blended tibial bearing components and Vitamin E blended patella components to the product offering.

This is a 510(k) premarket notification for a medical device (Arthrex iBalance® TKA System - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis), not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, sample sizes, ground truth, expert adjudication, MRMC studies, and training/test sets is not applicable in the context of an AI/ML device.

Here's why:

• Device Type: The document describes a traditional medical device (a knee replacement system), not a software or AI/ML-driven diagnostic or therapeutic tool.
• Regulatory Pathway: A 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device, primarily through performance testing (e.g., mechanical tests) and material characterization, rather than clinical efficacy studies often found in AI/ML device submissions.
• Content of the Document: The summary focuses on material properties, design changes (addition of Vitamin E blended components), and mechanical testing to demonstrate that the new components perform similarly to the predicate devices and meet industry standards. There is no mention of algorithms, data sets for training or testing, or human reader performance.

However, I can extract the general acceptance criteria and the study type conducted from the document, tailored to the context of this traditional medical device:

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

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

• Sample Size: Not explicitly stated in the provided text. The testing would involve a certain number of physical device components for mechanical testing.
• Data Provenance: Not applicable in the context of patient data. The provenance relates to laboratory testing of manufactured components.

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

• Not applicable. "Ground truth" in the AI/ML sense (e.g., expert consensus on clinical findings) is not relevant for the mechanical testing of a knee implant. The "ground truth" here would be the physical properties and performance characteristics determined by validated testing methods.

4. Adjudication method for the test set:

• Not applicable. Adjudication is typically associated with human interpretation of data. For mechanical testing, the results are quantitative and compared against established engineering 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-assisted device, so MRMC studies are not relevant.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• Material and mechanical performance standards. The "ground truth" for this device's performance would be established engineering specifications, material properties, and outputs from standardized mechanical tests (wear, fatigue, shear).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the AI/ML sense.

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

• Not applicable. No training set for an AI/ML algorithm is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study referenced is a series of mechanical performance tests. The document states:

• "The wear, fatigue and shear testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards."
• "Based on the indication for use, technological characteristics, and the summary of mechanical testing data submitted, Arthrex, Inc. has determined that the Arthrex iBalance® TKA System is substantially equivalent to currently marketed predicate devices."

This indicates that specific laboratory tests for wear, fatigue, and shear properties were conducted on the device components (including the new Vitamin E blended components). The results of these tests were then compared against predetermined acceptance criteria derived from FDA guidance and established industry standards for knee prostheses. The successful outcome of these tests led to the conclusion that the device performs equivalently to previously cleared predicate devices and is suitable for its intended use.

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