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The Arthrex FibuLock Nail is used in the Fibula Repair System cleared under K160069. It is a stainless steel implant used with stainless steel bone screws for the fixation of fibula fractures and osteotomies. The Arthrex FibuLock Nail can be used with existing FDA cleared Arthrex Low Profile Cortical Screws (K141478, K143139 and K143614), Arthrex TightRope Syndesmosis Devices (K043248) and instrumentation required for the fixation of fibula fractures and osteotomies.

AI/ML Overview

The provided text describes the Arthrex FibuLock Nail, its predicate device, and the basis for its 510(k) clearance. However, it does not contain information related to acceptance criteria, human reader studies (MRMC), standalone algorithm performance, or ground truth establishment for a study proving device performance in the context of AI/ML.

The "Performance Data" section briefly mentions "Worst-Case Cross-Section Comparison" and "Axial pullout and torsion comparison testing," which are mechanical performance tests typical for orthopedic implants, not studies involving AI or human readers for diagnostic tasks.

Therefore, many of the requested details, particularly those pertaining to AI/ML device evaluation, cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria Type	Acceptance Criteria	Reported Device Performance
Mechanical Performance	(Not explicitly stated as "acceptance criteria" but implied outcomes of comparison testing)	Worst-Case Cross-Section Comparison conducted to assess the risk of decreased bending strength (no specific numerical data provided). Axial pullout and torsion comparison testing performed on the 2.7 mm distal screws (no specific numerical data provided).
Substantial Equivalence	Device is substantially equivalent to the predicate device in terms of basic design features and intended uses. Differences are minor and do not raise questions of safety or effectiveness.	The Arthrex FibuLock Nail's design features and intended uses are the same as the predicate. Minor differences noted do not raise safety/effectiveness concerns.

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

Test Set Sample Size: Not applicable. This document describes mechanical testing for an orthopedic implant, not a study with a "test set" of patient data for diagnostic or predictive purposes.
Data Provenance: Not applicable. The "data" refers to mechanical test results, not patient data from a specific country or collected retrospectively/prospectively.

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

Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert diagnosis, pathology) is not relevant for the mechanical testing described.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No. This document does not mention any MRMC studies or human reader performance.

6. If a standalone (algorithm only) performance study was done:

No. This document describes a physical medical device (an intramedullary nail), not an algorithm or AI system.

7. The type of ground truth used:

Not applicable. The relevant "ground truth" for this device would be its mechanical properties meeting engineering specifications, which is assessed through direct mechanical testing, not expert consensus or histopathology.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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