The Flex-Thread Fibula Pin System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a Fibula, and cortical screws to further enhance stability and fixation of the Fibula.

AI/ML Overview

This document is a 510(k) summary for the Flex-Thread Fibula Pin System, a medical device intended for the fixation of fibula fractures and osteotomies. It does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness in the context of diagnostic performance. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Device Performance (Summary)
Insertion & Removal	Performed (assumed to meet internal specifications)
Static & Fatigue 4-Point Bending	Performed (assumed to meet internal specifications)
Torsion Testing	Performed (assumed to meet internal specifications)
Implant Tip Flexibility Testing	Performed (assumed to meet internal specifications)
Biocompatibility	Established per ISO 10993-1 and relevant FDA guidance

Study Proving Device Meets Acceptance Criteria:

A nonclinical testing study was performed to characterize the performance of the Flex-Thread Fibula Pin System. The document states: "All necessary testing has been performed for the worst-case Flex-Thread Fibula Pin 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."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "test units representative of finished devices" for nonclinical testing. This typically implies a defined number of devices tested according to specific protocols, but the exact count is not given.
Data Provenance: Not applicable in the context of clinical data for this type of device. The testing described is nonclinical (bench testing).

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

Not applicable. The ground truth for mechanical testing is based on engineering specifications and direct measurement, not expert medical opinion.

4. Adjudication Method for the Test Set:

Not applicable for nonclinical mechanical testing.

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:

Not applicable. This device is a mechanical implant, not an AI/ML diagnostic aid for human readers.

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

Not applicable. This device is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used:

For mechanical performance (bench testing): Engineering specifications, established testing standards (e.g., ASTM standards implied by the type of tests), and direct physical measurements serve as the ground truth.
For biocompatibility: International Standard ISO 10993-1 and relevant FDA guidance.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable.

Summary of the Study:

The study described is a nonclinical performance evaluation of the Flex-Thread Fibula Pin System. It involved a series of bench tests to assess the mechanical properties and biocompatibility of the device, primarily to demonstrate substantial equivalence to predicate devices. Key tests included:

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

The material used, titanium 6Al-4V ELI (ASTM F136), was also assessed for biocompatibility according to ISO 10993-1 guidelines. The conclusion of these tests was that the device performs as intended and is substantially equivalent to its predicate devices in terms of indications for use, design, performance, and function. The document explicitly states: "Clinical data were not needed to support the safety and effectiveness of the subject device."

Summary

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October 30, 2017

IntraFuse LLC Robert Hoy Director of Research 124 South 600 West. Suite 100 Logan, Utah 84321

Re: K172943

Trade/Device Name: Flex-Thread Fibula Pin System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: September 22, 2017 Received: September 26, 2017

Dear Robert 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K172943

Device Name Flex-Thread Fibula Pin System

Indications for Use (Describe)

The Flex-Thread Fibula Pin System is intended for use in the fixation of fibula fractures and osteotomies.

Type of Use (Select one or both, as applicable)
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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 Fibula 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, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	September 22, 2017
Common Name:	Rod, fixation, intramedullary and accessories
Classification:	21 CFR 888.3020
Class:	II
Product Codes:	HSB

Indications for Use:

The Flex-Thread Fibula Pin System is intended for use in the fixation of fibula fractures and osteotomies.

Device Description:

Predicate Devices:

The Mahe Medical GmbH Mahe Fixation Plate and Screw System (K102845), the Sonoma Orthopedics Products, Inc. Sonoma Fibula Repair System (K142945, K160069) and the Acumed, LLC Acumed Small Bone IM Nail System (K143276, K071994, K031438) serve as the predicate devices.

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Technological Characteristics Comparison:

The Flex-Thread Fibula Pin System and its predicates are similar in design, function and size. Each device is designed to fix fibular 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 beyond the fracture. The Sonoma Fibula Repair System, the Acumed Small Bone IM Nail System, and the subject device system all contain cortical screws as well.

The Flex-Thread Fibula Pin System subject device implants and the Acumed Small Bone IM Nail System predicate device implants are manufactured from titanium 6Al-4V ELI (ASTM F136), a material with well-established biocompatibility and a long history of use in many previously cleared permanent implants. The biocompatibility of the finished subject device implants and patient-contacting, device-specific instruments has been established per ISO 10993-1 and the relevant FDA guidance.

Nonclinical Testing:

All necessary testing has been performed for the worst-case Flex-Thread Fibula Pin 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 Fibula Pin System performance was characterized through the following tests:

Insertion & Removal Testing ●
Static & Fatigue 4-Point Bending Testing
Torsion Testing
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 Fibula Pin System to the Mahe Fixation Screw predicate device. The Flex-Thread Fibula Pin System is substantially equivalent to the Mahe Medical GmbH Mahe Fixation Plate and Screw System (K102845), the Sonoma Orthopedics Products, Inc. Sonoma Fibula Repair System (K142945, K160069) and the Acumed. LLC Acumed Small Bone IM Nail System (K143276, K071994, K031438) 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.