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The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

Device Description

The Arthrex Distal Extremity Plate System is comprised of a variety of flat and pre-contoured plate geometries. The plates are manufactured from titanium and feature both locking and non-locking holes. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screws are solid and may be either locking or non-locking.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Arthrex Distal Extremity Plate System. This type of submission relies on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting new clinical trials to establish novel safety and effectiveness. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, human readers, and ground truth in the context of an AI/algorithm-based device is not fully applicable here.

However, I can extract the relevant information about how "acceptance criteria" (which are framed as demonstration of substantial equivalence through mechanical testing) and "study" (mechanical testing) are addressed in this 510(k) submission.

Here's a breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

For a medical device like the Arthrex Distal Extremity Plate System, "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through comparisons of material, design, intended use, and performance, often relying on mechanical testing.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary of Mechanical Testing)
Material Equivalence: Composed of titanium that is substantially equivalent to predicate devices.	The proposed devices are composed of titanium that is substantially equivalent to the predicate devices.
Bending Strength Equivalence: Bending strength of the plates is substantially equivalent to that of the predicate devices.	The submitted mechanical testing data demonstrated that the bending strength of the plates is substantially equivalent to that of the predicate devices.
Torque and Pull-Out Force Equivalence: Torque and pull-out force of the screws are substantially equivalent to that of the predicate devices.	The submitted mechanical testing data demonstrated that the torque and pull-out force of the screws are substantially equivalent to that of the predicate devices.
Intended Use & Technological Characteristics Equivalence: Intended use and technological characteristics are consistent with predicate devices.	Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the Distal Extremity Plate System is substantially equivalent to currently marketed predicate devices.

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

Sample Size for Test Set: Not specified in the provided text for the mechanical testing. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ASTM, ISO) to achieve statistical significance for the property being tested (e.g., fatigue life, bending modulus).
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Mechanical testing data is typically generated in a laboratory setting.

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

Not applicable in the context of mechanical testing for substantial equivalence. "Ground truth" in this context refers to established material properties and biomechanical performance standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are typically based on objective measurements and calculations, not on human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic performance of imaging devices or algorithms with human readers, which is not the purpose of this 510(k) submission for a bone fixation system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical bone fixation system, not an algorithm.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" for the mechanical testing would be the accepted engineering standards and the established performance characteristics of the predicate devices. The goal is to demonstrate that the new device's performance aligns with these benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence through mechanical testing and comparison of material properties, design, and intended use to existing predicate devices. It does not involve the types of studies typically associated with AI/algorithmic devices that require human expert input or "ground truth" establishment in a diagnostic context.

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