The Akros Scruture Anchor LisFranc 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 in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).

Device Description

The Akros Scruture Anchor Lisfranc 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 bones of the midfoot during the healing process following a Lisfranc injury. The design of the implant permits placement through any fracture repair plate that can accept a 4.0mm 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 is a 510(k) premarket notification letter and summary for a medical device called the "Akros Scruture Anchor LisFranc Repair Kit."

Based on the content of the document, the device described is a metallic bone fixation appliance, not an Artificial Intelligence/Machine Learning (AI/ML) enabled device. Therefore, the information typically required for an AI/ML device's acceptance criteria and study proving its performance (such as ROC curves, sensitivity/specificity, sample sizes for AI model training/testing, expert ground truth establishment, etc.) is not present in this document.

The document focuses on the substantial equivalence of this physical implant device to a predicate device, primarily through non-clinical testing (e.g., mechanical testing, biocompatibility).

Here's what can be extracted, acknowledging the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria and reported device performance in the manner expected for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that:

Acceptance Criteria Category (for physical device)	Reported Device Performance (Summary)
Mechanical Performance Testing (e.g., pull-to-failure, load-to-failure, torque, fatigue, fretting, pitting corrosion)	"The results of these tests indicate that the performance of the Scruture Anchor device is adequate for its intended use." Data was adopted from a reference device due to design similarity.
Biocompatibility (e.g., cytotoxicity, pyrogenicity, bacterial endotoxin)	"Results demonstrated that the reference device meets an endotoxin limit of <20 EU/device." (For Bacterial Endotoxin Testing)

2. Sample sizes used for the test set and the data provenance

Test Set (for AI/ML): Not applicable. This is a physical implant device, not an AI/ML algorithm.
Data Provenance: The testing appears to be primarily lab-based (non-clinical) mechanical and chemical testing, rather than human subject data or image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth in the context of expert review for AI/ML performance is not relevant for this physical device's evaluation. Its "performance" is assessed through engineering and material science tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is described as this is not an AI/ML device relying on human interpretation for ground truth.

5. 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

No. This device is a bone fixation kit, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by standardized material and mechanical testing methods (e.g., ASTM standards for mechanical properties like pull-to-failure, torque-to-failure) and biocompatibility tests. It is not based on expert consensus, pathology, or clinical outcome data in the context of "ground truth" for an AI model.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI model.

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

Not applicable. There is no training set for an AI model.

Summary

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April 6, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Akros Medical Charles Horrell Chief Executive and Co-Founder 3503 Pleasant Green Rd Durham, North Carolina 27705

Re: K200361

Trade/Device Name: Akros Scruture Anchor LisFranc 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: February 10, 2020 Received: February 14, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200361

Device Name

Akros Scruture Anchor LisFranc Repair Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区Prescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) Summary
Prepared:	February 10th, 2020
Submitter:	Akros Medical3503 Pleasant Green RdDurham, NC 27705
Contact:	Charles HorrellChief Executive Officer and Co-Founder248.259.5535chuck@akrosmedical.com
Proprietary Name:	Akros Scruture Anchor LisFranc Repair Kit
Common Name:	Lisfranc 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 Mini TightRopeTM (K061925)
Reference Device:	Akros FibuLinkTM (K162805)

Device Description:

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Intended Use / Indications:

Summary of Technologies/Substantial Equivalence:

The Akros Scruture Anchor Lisfranc 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:

Lateral pull-to-failure testing was conducted. Data from simulated use, offset load-to-failure, insertion torque, torque-to-failure, fatigue with pull-to-failure, fretting, pitting corrosion, magnetic resonance, cytotoxicity, and pyrogenicity testing were adopted from the reference device (the Akros FibuLink Syndesmosis Repair System) given the similarity of its design and manufacture. The results of these tests indicate that the performance of the Scruture Anchor device is adequate for its intended use.

Bacterial Endotoxin Testing was performed on the reference device, which is considered worst case, using the Limulus Amebocyte Lysate (LAL) test. Results demonstrated that the reference device meets an endotoxin limit of <20 EU/device.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Akros Scruture Anchor Lisfranc 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.