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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.

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 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.

Explanation: The document states, "The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use" for all listed non-clinical tests, and specifically quantifies the endotoxin results. The acceptance criteria for "adequacy" are implied to be established against relevant standards for medical devices of this type, which are not explicitly detailed in this summary.

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

This information is not applicable or not provided for clinical performance, as clinical testing was not conducted. For the non-clinical tests, the specific sample sizes used for mechanical, material, and biocompatibility testing are not detailed in this summary.

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

This information is not applicable or not provided, as clinical testing with human-established ground truth was not performed.

4. Adjudication Method for the Test Set

This information is not applicable or not provided, as clinical testing was not performed.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the FibuLink™ Syndesmosis Repair Kit to the predicate device." Therefore, there is no effect size of human readers improving with or without AI assistance.

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

This is not applicable. The Akros FibuLink™ Syndesmosis Repair Kit is a physical orthopedic fixation device, not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by engineering and materials testing standards and protocols, which define acceptable performance parameters for mechanical strength, biocompatibility, and other physical properties inherent to the device's function. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient diagnosis/treatment) was used for this submission.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

This information is not applicable. There is no ground truth for a training set as this is not an AI/algorithm-based device.

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