The Flex-Thread™ Distal Fibula Intramedullary Nail 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 FDA 510(k) summary describes a modification to an existing medical device, the Flex-Thread™ Distal Fibula Intramedullary Nail System, rather than the initial clearance of a novel AI/Ml medical device. Therefore, the information typically requested regarding acceptance criteria, study design for AI performance, sample sizes, and ground truth establishment, as it pertains to AI algorithms, is not applicable in this context.

The submission is a Special 510(k) to introduce a larger diameter nail (5.5mm) and an additional end cap (1mm) to an already cleared system. The focus of the provided text is on demonstrating the substantial equivalence of these mechanical modifications to the predicate device, not on the performance of a software algorithm.

Here's a breakdown of why this information is not present and what was done instead:

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

Not Applicable. This document does not describe performance metrics for an AI algorithm. Instead, it states that "Mechanical testing was performed on the modified Flex-Thread™ Distal Fibula Intramedullary Nail System using the same protocols as those used to verify the Flex-Thread™ Distal Fibula Intramedullary Nail System design as part of K202858." The tests included "Tip Reaction Force, Insertion Torque, and Simulated Use Cadaver Lab." The conclusion is that "The results design inputs meet design outputs and substantial equivalence of the subject device to the predicate." This implies that the acceptance criteria were met for these mechanical tests, but specific quantitative acceptance criteria or detailed results are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. This refers to sample sizes for mechanical testing (e.g., number of nails tested, number of cadavers). The document mentions "Simulated Use Cadaver Lab" but does not specify the number of cadavers or the origin of the cadaveric material.

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. This is relevant for AI image analysis or diagnostic devices. No expert review for ground truth is described for this mechanical device modification.

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

Not Applicable. This pertains to expert review in AI studies.

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 is specifically for AI-assisted diagnostic devices.

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

Not Applicable. This is for AI algorithm performance.

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

Not Applicable. Ground truth for AI algorithms. For a mechanical device, performance is evaluated against engineering specifications and biomechanical principles.

8. The sample size for the training set:

Not Applicable. No AI model training is described.

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

Not Applicable. No AI model training is described.

In summary, the provided document is a regulatory submission for a modification to a mechanical orthopedic implant, not an AI/ML medical device. Therefore, questions related to AI algorithm performance, training, and ground truth are not relevant to this content.

Summary

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Flower Orthopedics Corporation DBA Conventus Flower Amanda Pentecost RA/QA Engineer 100 Witmer Road Horsham, Pennsylvania 19044

Re: K212030

Trade/Device Name: Flex-Thread™ Distal Fibula Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 28, 2021 Received: June 29, 2021

Dear Amanda Pentecost:

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

July 23, 2021

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K212030

Device Name

Flex-Thread™ Distal Fibula Intramedullary Nail System

Indications for Use (Describe)

The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

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

< | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Contact Details 21 CFR 807.92(a)(1) Flower Orthopedics Corporation DBA Conventus Flower Orthopedics Applicant Name Applicant Address 100 Witmer Road Suite 280 Horsham PA 19044 United States 215-323-4029 Applicant Contact Telephone Applicant Contact Dr. Amanda Pentecost Applicant Contact Email apentecost@flowerortho.com Device Name 21 CFR 807.92(a)(2) Flex-Thread™ Distal Fibula Intramedullary Nail System (Multiple Device Trade Name Component PNs) Rod, Fixation, Intramedullary And Accessories Common Name Classification Name Intramedullary fixation rod Regulation Number 888.3020 Product Code HSB Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K202858 Flex-Thread™ Distal Fibula Intramedullary Nail System HSB Device Description Summary 21 CFR 807.92(a)(4) The Flex-Thread™ Distal Fibula Intramedullary Nail 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.

Intended Use/Indications for Use

The Flex-Thread TM Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

Indications for Use Comparison

This Special 510(k) is submitted to introduce a 5.5mm diameter nail in 130mm lengths as well as an additional end cap that is 1 mm to the Flex-Thread System. The Flex-Thread System have identical indications for use as the predicate device Flex-Thread System.

Technological Comparison

The only difference between the predicate device is the introduction of a larger nal with a diameter of 5.5mm compared to the originally cleared 3.5mm diameter nails. Additionally a shorter 1mm end cap has been added to the

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 607.32(a)(3)

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predicate offering of 3mm, 5mm and 10mm.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Mechanical testing was performed on the modified Flex-Thread™ Distal Fibula Intramedullary Nail System using the same protocols as those used to verify the Flex-Thread™ Distal Fibula Intramedullary Nail System design as part of K202858. These tests included Tip Reaction Force, Insertion Torque, and Simulated Use Cadaver Lab. Additionally, engineering justifications were provided for 4-Point Bend and Torque Strength testing. The results design inputs meet design outputs and substantial equivalence of the subject device to the predicate.

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.