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The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Device Description

The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.

The current submission is for minor design modifications to the components that make up the tibia and fibula anchors and corresponding changes to some of the tools used to install them.

AI/ML Overview

This document is a 510(k) premarket notification for the Akros FibuLink™ Syndesmosis Repair Kit. It describes the device, its intended use, and a summary of non-clinical testing conducted. However, it explicitly states that clinical testing was not necessary to demonstrate substantial equivalence to the predicate device.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies cannot be provided from the given text.

The information that can be extracted relates to the non-clinical testing performed to establish equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a qualitative statement about the outcomes.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Lateral pull-to-failure	Adequate strength for intended use; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Offset load-to-failure	Adequate strength for intended use; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Insertion torque	Appropriate torque for bone insertion	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Torque-to-failure	Adequate resistance to failure; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Fatigue with pull-to-failure	Adequate durability for intended use; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."

Note: The phrase "adequate for its intended use" implies that the results met internal specifications or were comparable to the predicate device, which functioned as the de facto "acceptance criteria" for demonstrating substantial equivalence through non-clinical testing.

The following questions cannot be answered from the provided text as the application explicitly states that clinical testing was not necessary.

Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set mentioned.
Adjudication method for the test set: Not applicable; no clinical test set mentioned.
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: Not applicable; this device is a physical medical device, not an AI/software product, and no clinical studies were performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a physical medical device.
The type of ground truth used: Not applicable; no clinical ground truth was established as no clinical testing was performed.
The sample size for the training set: Not applicable; this device is a physical medical device, not an AI/software product, and no training set was used in the context of an algorithm.
How the ground truth for the training set was established: Not applicable; no training set or ground truth in the context of a study was established.

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K Number

K162805

Device Name

Akros Fibulink Syndesmosis Repair Kit

Manufacturer

Akros Medical

Date Cleared

2017-01-10

(97 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K043248

Intended Use

Device Description

AI/ML Overview

The provided document describes the Akros FibuLink™ Syndesmosis Repair Kit, a medical device for orthopedic fixation. However, it explicitly states that clinical testing was not necessary to demonstrate substantial equivalence to the predicate device. Therefore, a study proving the device meets acceptance criteria based on clinical performance metrics is not detailed in this document.

The document focuses on non-clinical testing for substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical testing was not performed or necessary for this 510(k) submission, there are no acceptance criteria related to clinical performance (e.g., sensitivity, specificity, accuracy). The document primarily outlines non-clinical testing results.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Simulated use	Adequate for intended use
Lateral pull-to-failure	Adequate for intended use
Offset load-to-failure	Adequate for intended use
Insertion torque-to-failure	Adequate for intended use
Fatigue with pull-to-failure	Adequate for intended use
Fretting	Adequate for intended use
Pitting corrosion	Adequate for intended use
Magnetic resonance (MR compatibility)	Adequate for intended use
Cytotoxicity	Adequate for intended use
Pyrogenicity	Adequate for intended use
Endotoxin testing	Met recommended limit of

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