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The ARIX Ankle Distal Tibia System(Ankle fusion) is indicated for facilitating arthrodesis of the ankle including tibiotalcaneal and tibiotalar joints.

The ARIX Ankle Distal Tibia System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes.

The ARIX Ankle Distal Tibia System is made of Titanium Alloy (Ti-6AI-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

This document is a 510(k) Premarket Notification for the ARIX Ankle Distal Tibia System. It states that no clinical studies were considered necessary and performed. Therefore, a study demonstrating the device meets acceptance criteria, an MRMC comparative effectiveness study, or a standalone algorithm-only study were not conducted or reported in this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Since no clinical study was performed, there are no reported acceptance criteria or device performance measurements in terms of clinical outcomes or diagnostic accuracy. The testing performed focused on compliance with material and mechanical standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical test set was used. The testing was non-clinical bench testing of the physical device components.

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, as no clinical test set or ground truth established by medical experts was used.

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

Not applicable, as no clinical test set requiring adjudication was used.

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 MRMC comparative effectiveness study was done. The device is a physical bone fixation system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical bone fixation system.

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

Not applicable, as no clinical ground truth was established for this device, which is a physical implant. The "ground truth" for the non-clinical testing was compliance with established ASTM standards for material properties and mechanical performance.

8. The sample size for the training set

Not applicable, as no training set was used. The device is a physical bone fixation system, not a machine learning model.

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

Not applicable, as no training set or its ground truth was established.

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