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The ARIX Rib System is indicated for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

The ARIX Rib System is composed locking bone plate and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. The ARIX Rib System is made of Unalloyed Titanium and Titanium Alloy (Ti-6Al-4V). The bone plates consist of straight type and curved type which has different lengths and number of plate holes. The bone screws are compatible with K181806 ARIX Sternal System Bone Screw previously cleared. The screws are 2.4 and 2.7mm in diameter with self-tapping and provided with lengths from 8.0 to 20.0mm.

This document describes the device as the ARIX Rib System, a metallic bone fixation appliance and accessory.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical studies were considered necessary and performed."
Therefore, there is no information regarding a test set, sample size, or data provenance from clinical trials. The evaluation was based solely on non-clinical (bench) testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

Given the absence of clinical studies, there was no "test set" in the context of human data requiring expert ground truth establishment. The ground truth for the bench tests was the established performance specifications outlined in the ASTM standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No MRMC comparative effectiveness study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable to this device. The ARIX Rib System is a physical medical device (bone plates and screws), not an AI algorithm. Its "performance" is assessed through mechanical and material properties as per industry standards, not through algorithmic evaluations.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the ground truth was defined by the specifications and requirements outlined in the referenced ASTM standards:

• ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
• ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws

8. The Sample Size for the Training Set

Not applicable. The ARIX Rib System is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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