The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Device Description

The Interphalangeal Joint Fusion Device Range consists of metallic devices intended to stabilize two bone fragments until bone fusion. They are available in several lengths and angulations. All the implants are made of titanium alloy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Interphalangeal Joint Fusion Device Range." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving improved diagnostic accuracy or effectiveness through clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria for AI performance (like sensitivity, specificity, or AUC), and the detailed methodology of studies proving device performance with AI, is not applicable to this submission.

Here's why and what information is available:

Device Type: This is a physical implant (metallic bone fixation fastener), not an AI/software device.
Regulatory Pathway: The 510(k) pathway for traditional medical devices relies heavily on demonstrating substantial equivalence to existing devices based on technological characteristics and performance data, often through non-clinical (mechanical) testing.
Focus of the Submission: The submission highlights similarities in intended use, materials, design, dimensions, sterilization, and performance specifications compared to predicate devices.

Given this context, I will address the relevant points from your prompt based on the provided document.

Acceptance Criteria and Study for Interphalangeal Joint Fusion Device Range

The acceptance criteria for this device, as demonstrated through the 510(k) submission, revolve around establishing substantial equivalence to existing predicate devices. This is primarily achieved by showing comparable or superior mechanical performance and similar technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use	Device's intended use is substantially equivalent to predicate devices.	The Interphalangeal Joint Fusion Devices and all predicates have similar intended uses.
Materials	Device materials are the same as or comparable to predicate devices and conform to recognized standards (e.g., ISO, ASTM).	Fabricated from Titanium alloy per ISO 5832-3 / ASTM F136, the same material as the predicate devices.
Design Features/Functions	Device's basic design features and functions are similar to predicate devices.	Shares similar basic design features and functions with cited predicate devices.
Dimensions	Device dimensions are similar to predicate devices.	Dimensionally similar to the cited predicate devices.
Sterilization	Device sterilization method and state (sterile/non-sterile) are consistent with predicate devices.	Provided sterile, as are the cited predicate devices.
Mechanical Performance (Non-Clinical)	Device demonstrates equivalent or superior mechanical performance compared to predicate devices under specified test conditions (e.g., static bending, dynamic bending, axial pull-out).	Mechanical testing confirmed the Interphalangeal Joint Fusion Devices demonstrated as good or better performances than the cited predicate devices under the same test conditions. Results indicated they are as strong or stronger than predicate devices.

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of clinical patient data or AI performance. For mechanical testing, the "samples" would refer to the number of devices tested. The document does not specify the exact number of devices tested for each mechanical test (static bending, dynamic bending, axial pull-out).
Data Provenance: The mechanical tests were performed by the manufacturer (NEOSTEO). No other provenance information (e.g., country of origin, retrospective/prospective) is relevant as these are laboratory-based engineering performance tests on the device itself.

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

Not applicable. This submission does not involve AI performance evaluation or a "ground truth" established by human experts in the diagnostic sense. The "ground truth" for the mechanical tests would be the established engineering standards and physical measurements.

4. Adjudication Method for the Test Set

Not applicable. There was no human expert adjudication of results, as this was mechanical testing of a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted as this is a physical medical device submission, not an AI-assisted diagnostic or prognostic tool. The concept of "human readers improve with AI vs without AI assistance" does not apply.

6. Standalone (Algorithm Only) Performance

No. This is not an AI/algorithm-only device. Therefore, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used

Mechanical Test Standards/Measurements: The "ground truth" for proving the device meets performance criteria relies on objective measurements from mechanical tests (static bending, dynamic bending, axial pull-out) and comparison against the performance of predicate devices under the same test conditions. Compliance with recognized material standards (ISO 5832-3 / ASTM F136) also contributes to the "ground truth" for material properties.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable. As there is no AI algorithm or training set, this question is not relevant.

Summary

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August 28, 2019

Neosteo % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4314 W. 3800 S. West Haven, Utah 84401

Re: K191424

Trade/Device Name: Interphalangeal Joint Fusion Device Range Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 8, 2019 Received: August 12, 2019

Dear Mr. Webb:

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

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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 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 medical devices and radiation-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 RPJ

Ronald Jean, Ph.D. Assistant Director DHT6B: Division of Spinal 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

510(k) Number (if known) K191424

Device Name

Interphalangeal Joint Fusion Device Range

Indications for Use (Describe)

The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Type of Use (Select one or both, as applicable)
ly Prescription Use (Part 21 CFR 801 Subpart D)	_ Over-The-Counter Use (21 CFR 801 Subp

lion 300 (Part 21 SFR 301 Support B)

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

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510(k) Summary

l. SUBMITTER'S INFORMATION

A. 510(k) Owner

NEOSTEO Mallève 2A 1 Boulevard Jean Moulin 44 100 Nantes, France Tel: +33 (0)2 36 56 96 70 Fax: +33 (0)2 51 70 61 34

B. Contact Person

JD Webb The Orthomedix Group, Inc. 4314 W. 3800 S. West Haven, UT 84401 Tel: 512 590 5810 Email: jdwebb@orthomedix.net

C. Date of Preparation of the 510(k) Summary

8th August 2019

DEVICE IDENTIFICATION II.

Trade or proprietary name	Interphalangeal Joint Fusion Device Range
Common or usual name	Interphalangeal Joint Fusion Device Range
Classification regulation	21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
Proposed Regulatory Class	Class II
Panel	87 "Orthopedic"
Product code	HWC
Primary Predicate Device	HammerFix® (K133636) from Extremity Medical
	ProToe® (K101165) from Wright Medical
Secondary Predicate Devices	Kirschner and Guide Wires (K100736) from SMT Schilling Metalltechnik GmbH

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Image /page/4/Picture/1 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font.

510(k) Summary

III. DEVICE DESCRIPTION

A. Materials

Titanium alloy per ISO 5832-3 / ASTM F136.

IV. INDICATIONS FOR USE

The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Intended Use	The Interphalangeal Joint Fusion Devices and all the predicates havesimilar intended uses.
Materials	The Interphalangeal Joint Fusion Devices are fabricated of the samematerial as the predicate devices.
DesignFeatures/Functions	The Interphalangeal Joint Fusion Devices and the cited predicatedevices share similar basic design features and functions.
Dimensions	The Interphalangeal Joint Fusion Devices are dimensionally similar to thecited predicate devices.
Sterilization	The Interphalangeal Joint Fusion Devices are provided sterile as are thecited predicate devices.
PerformanceSpecification	Mechanical testing confirmed the Interphalangeal Joint Fusion Devicesdemonstrated as good or better performances than the cited predicatedevices under the same test conditions.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL EQUIVALENCE V.

VI. NON-CLINICAL TEST SUMMARY

The following mechanical tests were performed:

o Static bending test
o Dynamic bending test

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Image /page/5/Picture/1 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller, lighter font.

510(k) Summary

o Axial pull-out test

The results of these tests indicate that the Interphalangeal Joint Fusion Devices are as strong or stronger than predicate devices.

CLINICAL TEST SUMMARY VII.

No clinical studies were performed.

CONCLUSIONS NON-CLINICAL AND CLINICAL VIII.

NEOSTEO considers the Interphalangeal Joint Fusion Devices to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.