The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults. The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3). Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Footmotion HammerToe." It's a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML device, as this is a traditional medical device (an implant).

Here's an analysis based on the provided text, aligning with your request, but highlighting the differences for a non-AI/ML device:

1. Table of acceptance criteria and reported device performance:

Since this is an orthopedic implant, the "acceptance criteria" and "device performance" are not about AI model metrics like sensitivity or specificity. Instead, they refer to the physical and mechanical properties of the implant. The document states that the device is substantially equivalent to predicate devices based on:

Acceptance Criteria (Implied)	Reported Device Performance
Material Composition (Biocompatibility & Strength)	Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136-13 and ISO 5832-3)
Mechanical Performance (Resistance to Flexion & Pull-out)	Passed "Flexion tests" and "Pull out tests"
Functionality (Ability to fix bone for arthrodesis)	Implants are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
Sterilization Compatibility	Provided non-sterile for health sterilization by care professionals prior to use, or provided sterile by gamma sterilization.
Substantial Equivalence to Predicate Devices (Overall)	Claimed substantial equivalence in terms of intended use, design, materials used, mechanical safety and performance.

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

Sample size for test set: Not applicable in the context of an AI/ML model. The "tests" mentioned are biomechanical tests on the device itself, not clinical data.
Data provenance: Not applicable for this type of device. The tests were performed on the physical implant. The manufacturer, NEWCLIP TECHNICS, is based in France.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in the context of this device refers to established engineering standards (ASTM, ISO) for material properties and performance. Biomechanical testing doesn't typically involve human experts establishing "ground truth" for the test results in the same way an AI model might. The "experts" would be engineers designing and conducting the tests according to established protocols.

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

Not applicable. This concept applies to human review of data to establish ground truth, not to physical device 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:

No. This is an orthopedic implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

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

Not applicable. This is not an algorithm.

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

For the non-clinical tests (flexion, pull-out), the "ground truth" is defined by established engineering standards and material specifications (ASTM F136-13 and ISO 5832-3 for the material) and the expected mechanical behavior for an implant of this type, as demonstrated by predicate devices. The tests aimed to show that the device meets these physical and mechanical performance expectations.

8. The sample size for the training set:

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

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

Not applicable.

Summary of the study/evidence for device acceptance:

The device's acceptance is based on a non-clinical study involving mechanical testing:

Flexion tests
Pull out tests

The purpose of these tests was to demonstrate the mechanical safety and performance of the Footmotion HammerToe range. The conclusion drawn is that the device is substantially equivalent to legally marketed predicate devices (Memometal Intra-medullary Bone Fastener, Pro-Toe Vo Hammertoe Implant System, Nextra Ti Hammertoe Correction System) based on:

Similar principles of operation
Similar technology
Similar materials
Similar indications for use

The submission explicitly states: "No clinical studies were performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

Summary

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March 2, 2018

Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K172485

Trade/Device Name: Footmotion HammerToe Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: February 16, 2018 Received: February 20, 2018

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. 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 (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

510(k) Number (if known) K172485

Device Name

Footmotion HammerToe

Indications for Use (Describe)

The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

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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Image /page/3/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo consists of the letters "nct" in a circle, with the "t" in a different color (reddish-pink) and an arrow pointing upwards. The company name is written in capital letters below the circle.

510 (k) Summary for the Footmotion HammerToe range

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the HammerToe system.

Summary preparation date: March, 2017

1. Submitter:	Contact Person:
NEWCLIP TECHNICSP.A. de la Lande Saint Martin45 rue des GarottièresF-44115 Haute-Goulaine -FranceTelephone: (33) 2 28 21 37 12	J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199
2. Trade name:	Footmotion HammerToe
Common Name:	Smooth or threaded metallic bonefixation fastener.
Product code:	HTY
Classification Name:	Smooth or threaded metallic bonefixation fastener(21 CFR part. 888.3040)

3. Primary predicate or legally marketed devices which are substantially equivalent:

Memometal Intra-medullary Bone Fastener of MEMOMETAL . TECHNOLOGIES (K070598 / K112197)
K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.

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Image /page/4/Picture/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters "nct" in a circle, with the "t" having an upward-pointing arrow as part of its design. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.

Secondary predicate or legally marketed devices which are substantially equivalent:

Pro-Toe Vo Hammertoe Implant System of WRIGHT MEDICAL . TECHNOLOGIES (K101165)
Nextra Ti Hammertoe Correction System of NEXTREMITY . SOLUTION, INC (K122031)

Reference predicate or legally marketed devices which are substantially equivalent:

Trim-it drill pin of ARTHREX (K050259) .
1. Description of the device: The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults.

The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization.

Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3).
Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

5. Substantial equivalence claimed to predicate devices:

The Footmotion HammerToe range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

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Image /page/5/Picture/1 description: The image shows a logo for a company called "NEWCLIP-TECHNICS". The logo features the letters "nct" inside of a circle. The "t" in "nct" has a red arrow pointing upwards. The company name is written in all caps below the circle.

6. Intended use:

The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

7. Non-clinical Test Summary:

The following tests were conducted:

Flexion tests .
Pull out tests .

8. Clinical Test Summary:

No clinical studies were performed.

9. Conclusions Non-clinical and Clinical:

Newclip considers the Footmotion HammerToe range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's 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.