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The Arzzt Distal Radius and Ulna System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

The Arzzt Distal Radius and Ulna System consist in a variety of plates intended for dorsal and volar use, with orifices to receive either locking or non-locking screws. The screws are can be total or partially threaded, some are self-tapping and they can be with or without locking features. System is also available with locking pegs. All plates and screws may be manufactured in stainless steel (ASTM F138) and titanium (ASTM F136). The System is non-sterile and single use only.

This document is a 510(k) premarket notification for the "Arzzt Distal Radius and Ulna System," a metallic bone fixation appliance. The document asserts substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the provided information, focusing on acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the exact sample sizes (number of plates, screws, or test repetitions) used for the non-clinical mechanical testing.
• The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was "engineering analyses" and "ASTM F543 testing," implying laboratory testing rather than human subject data.

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

• This information is not applicable. The "ground truth" for non-clinical mechanical testing is not established by human experts in the way clinical ground truth (e.g., diagnosis from a radiologist) would be. The ground truth relies on established engineering principles and ASTM standards.

4. Adjudication Method for the Test Set:

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or interpretations. For non-clinical mechanical testing, the results are quantitative and objective, based on physical measurements and engineering calculations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• This information is not applicable. The Arzzt Distal Radius and Ulna System is a medical device for orthopedic fixation (plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of this device.

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

• This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• The ground truth for the non-clinical testing is based on ASTM F543 standards for screw performance and general engineering principles for comparing the static bending and torsional yield strengths of plates. This is objective, standardized, and reproducible mechanical performance data.

8. The Sample Size for the Training Set:

• This information is not applicable. The Arzzt Distal Radius and Ulna System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• This information is not applicable, as there is no "training set" for this type of device.

Summary of the Study:

The study described is a non-clinical, in-vitro mechanical testing and engineering comparison study. It aims to demonstrate that the Arzzt Distal Radius and Ulna System's components (plates and screws) perform equivalently or acceptably compared to legally marketed predicate devices.

• Plates: Underwent engineering analyses to compare static bending and static torsional yield strengths. The conclusion was that the Arzzt locking plates are "as strong as the predicate devices."
• Screws: Underwent ASTM F543 testing and engineering analyses to compare maximum shear stress and thread characteristics. The comparison aimed to show substantial equivalence to the predicate device's screws.

Essentially, the study relies on established engineering methodologies and industry standards (like ASTM F543) to demonstrate that the new device's mechanical properties are comparable to those of already cleared predicate devices, thereby supporting its safety and effectiveness without raising new questions regarding these aspects.

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