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.

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 <20 EU/device

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. These profiles are connected to three flowing shapes below, resembling fabric or ribbons. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 10, 2017

Akros Medical Mr. Charles Horrell CEO and Co-Founder 3503 Pleasant Green Rd Durham, North Carolina 27705

Re: K162805 Trade/Device Name: Akros FibuLink Syndesmosis Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: December 9, 2016 Received: December 12, 2016

Dear Mr. Horrell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K162805 510(k) Number (if known): _

Device Name: Akros FibuLink™ Syndesmosis Repair Kit

Indications for Use:

Prescription Use _X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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510(k) Summary

Prepared:	September 30, 2016
Submitter:	Akros Medical3503 Pleasant Green RdDurham, NC 27705
Contact:	Charles HorrellChief Executive Officer and Co-Founder248.259.5535chuck@akrosmedical.com
Proprietary Name:	Akros FibuLink™ Syndesmosis Repair Kit
Common Name:	Syndesmosis Repair Kit
Regulation and Class:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories; Class II
Product Code:	87/HTN
Predicate Device:	• Arthrex TightRope™ Syndesmosis Device, K043248

Device Description:

Intended Use / Indications:

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following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Summary of Technologies/Substantial Equivalence:

The FibuLink™ Syndesmosis Repair Kit is substantially equivalent to the predicate device in terms of its intended use and indications, materials, basic design and mechanical performance. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.

Non-Clinical Testing:

Simulated use, lateral pull-to-failure, offset load-to-failure, insertion torque-to-failure, fatigue with pull-to-failure, fretting, pitting corrosion, magnetic resonance, cytotoxicity, pyrogenicity and endotoxin testing were conducted. The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use. Endotoxin results demonstrated that the FibuLink™ device met the recommended limit of <20 EU/device.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the FibuLink™ Syndesmosis Repair Kit to the predicate device.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.