The Flex-Thread Clavicle Pin System is comprised of an intramedullary fixation device with a flexible threaded distal tip to engage the curved medial portion of a clavicle, and a proximal cross screw to further enhance stability and fixation to the lateral portion of the clavicle.

AI/ML Overview

This document describes the Flex-Thread Clavicle Pin System, a medical device, and its acceptance criteria for premarket notification (510(k)) to the FDA. The information provided is for device and mechanical performance testing, not AI/algorithm performance. Therefore, many of the requested fields related to AI study design (e.g., sample size for AI test set, expert ground truth, MRMC studies) are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Insertion & Removal Testing	Not explicitly stated, but implied to demonstrate safe and proper usage.	Performed.
Static 4-Point Bending	Not explicitly stated, but implied to meet or exceed predicate device performance.	Performed. Demonstrate that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness. Side-by-side performance testing demonstrates substantial equivalence to the Elastic Intramedullary Nail predicate device.
Fatigue 4-Point Bending	Not explicitly stated, but implied to meet or exceed predicate device performance for durability.	Performed. Demonstrate that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness. Side-by-side performance testing demonstrates substantial equivalence to the Elastic Intramedullary Nail predicate device.
Tensile Testing	Not explicitly stated, but implied to meet or exceed predicate device performance for strength.	Performed.
Torsion Testing	Not explicitly stated, but implied to meet or exceed predicate device performance for rotational forces.	Performed.
Implant Tip Flexibility Testing	Not explicitly stated, but implied to demonstrate appropriate flexibility as designed.	Performed.

Note: The document states that "The mechanical testing demonstrates that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness." and "Side-by-side performance testing demonstrates the substantial equivalence of the Flex-Thread Clavicle Pin System to the Elastic Intramedullary Nail predicate device." This implies the performance of the Flex-Thread Clavicle Pin System met or exceeded the performance of the predicate device for all tests.

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

This section is not applicable as the document describes mechanical and material testing of a physical medical device, not an AI/algorithm. No patient data or clinical images were used in this specific submission. All testing was performed on "test units representative of finished devices."

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

This section is not applicable. Ground truth, in the context of AI, refers to expert labeling of data. This document describes physical device testing, not AI performance evaluation.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods are used in studies involving human interpretation or expert consensus on data, typically in AI performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which is not described here. Clinical data were explicitly stated as "not needed to support the safety and effectiveness of the subject device" for this 510(k) submission.

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

This section is not applicable. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this medical device's performance is established through physical and mechanical testing standards and comparison to a legally marketed predicate device's performance. The "ground truth" here is the established safe and effective performance characteristics of similar devices, as demonstrated through objective mechanical tests.

8. The Sample Size for the Training Set

This section is not applicable. There is no training set mentioned, as this is not an AI/algorithm.

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

This section is not applicable. There is no training set for an AI/algorithm in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

March 20, 2017

Intrafuse LLC Robert Hoy Director of Research 124 South 600W, Suite 100 Logan, Utah 84321

Re: K163488

Trade/Device Name: Flex-Thread Clavicle Pin System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDW Dated: February 16, 2017 Received: February 17, 2017

Dear Mr. Hoy:

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

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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,

Lori A. Wiggins -S

for 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

510(k) Number (if known)

K163488

Device Name Flex-Thread Clavicle Pin System

Indications for Use (Describe)

The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union of the clavicle.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. 510(k) Summary

Device Trade Name:	Flex-Thread Clavicle Pin System
Manufacturer:	IntraFuse LLC124 South 600 West, Suite 100Logan, UT 84321
Contact:	Mr. Robert HoyDirector of ResearchPhone: (614) 448-6358Fax: (435) 213-4878bob@surgicalfrontiers.com
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	December 12, 2016
Common Name:	Rod, fixation, intramedullary and accessories;Pin, fixation, threaded
Classification:	21 CFR 888.3020, 21 CFR 888.3040
Class:	II
Product Codes:	HSB, JDW

Indications for Use:

The Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Device Description:

Predicate Devices:

The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma

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Orthopedic Products CRx Clavicle Fracture Repair Device (K081832, K100112) serve as the predicate devices.

Technological Characteristics Comparison:

The Flex-Thread Clavicle Pin System and its predicates are similar in design, function and size. Each device is designed to fix fractures from within the intramedullary canal. In addition, the subject and predicate device designs possess the ability to engage curved regions of the intramedullary canal. The CRx Clavicle Fracture Repair Device System, AOS Clavicle Intramedullary Device, and the subject device system contain cross screws as well.

The Flex-Thread Clavicle Pin System subject device implants and the Elastic Intramedullary Nail and CRx Clavicle Fracture Repair Device predicate device implants all contain stainless steel, a material with well-established biocompatibility and a long history of use in many previously cleared permanent implants. In addition the Flex-Thread Clavicle Pin implant contains polyetheretherketone (PEEK) conforming to ASTM F2026. The biocompatibility of this material has been established per ISO 10993-1. The mechanical testing demonstrates that the design differences between the Flex-Thread Clavicle Pin and the Elastic Intramedullary Nail introduce no new issues of safety or effectiveness.

Nonclinical Testing:

All necessary testing has been performed for the worst-case Flex-Thread Clavicle Pin and Cross Screw to assure substantial equivalence to its predicates and to demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices.

The Flex-Thread Clavicle Pin System performance was characterized through the following tests:

Insertion & Removal Testing
o Static & Fatigue 4-Point Bending Testing
Tensile Testing ●
Torsion Testing o
o Implant Tip Flexibility Testing

Clinical data were not needed to support the safety and effectiveness of the subject device.

Substantial Equivalence:

Side-by-side performance testing demonstrates the substantial equivalence of the Flex-Thread Clavicle Pin System to the Elastic Intramedullary Nail predicate device. The Flex-Thread Clavicle Pin System is substantially equivalent to the Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and CRx Clavicle Fracture Repair Device (K081832, K100112) with respect to its indications for use, design, performance and function.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.