The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults. The implants of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Footmotion Plating System will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial F MTP) contain implants and instruments or instruments only provided sterile by gamma sterilization.

AI/ML Overview

This document is a 510(k) premarket notification for the Footmotion Plating System. As such, it does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML performance evaluation. This device is a medical implant system, not a software or AI-driven diagnostic tool.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of submission. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical safety, rather than evaluating performance against a specific clinical metric.

Here's a breakdown of the information that is applicable or discernible from the provided text, along with an explanation for why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria for performance in the typical sense of accuracy, sensitivity, or specificity that would apply to an AI/ML device. Instead, "acceptance criteria" are implied through the demonstration of substantial equivalence to legally marketed predicate devices. The performance is assessed through engineering analyses and material testing to ensure the device is safe and effective for its intended use, similar to its predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: Similar to predicate devices.	"The Footmotion Plating System is substantially equivalent to the predicate devices in terms of intended use..." "The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." (Matches predicate's likely intended use implicitly)
Design: Similar to predicate devices.	"The Footmotion Plating System is substantially equivalent to the predicate devices in terms of... design..." "The Footmotion Plating System consists of plates and screws, designed for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults." (Implies design is appropriate for stated use and therefore comparable to predicates)
Materials: Biocompatible and mechanically suitable.	"Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3)." (Demonstrates use of a known, biocompatible, and mechanically sound material, equivalent to predicates.)
Mechanical Safety/Performance: Equivalent to predicate devices.	"Engineering analyses have been conducted in comparison with the predicate devices." (Implied acceptance is that these analyses demonstrate comparable mechanical performance and safety to predicates.)
Biocompatibility/Sterility: Meets relevant standards.	"LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of <20 EU/device." (Demonstrates biocompatibility regarding endotoxins.) "The implants... will be provided non sterile for sterilization... or provided sterile by gamma sterilization." (Describes sterilization practices which must meet standards to be deemed safe and effective, and thus 'acceptable').

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

Not Applicable in the traditional sense for an AI/ML device. This is a physical implant system. The "test set" would refer to samples of the device components undergoing various engineering and material tests.
The document mentions "Engineering analyses," which would involve testing physical samples (e.g., fatigue testing, tensile strength testing). The specific number of samples for each type of engineering analysis is not provided in this summary.
Data Provenance: The analyses and testing appear to be conducted by or for Newclip Technics, a French company. The nature of the analyses (e.g., bench testing, material characterization) means the "data provenance" is derived from these tests. These are prospective tests conducted specifically for this submission.

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

Not Applicable. For a physical device like this, there isn't a "ground truth" to be established by clinical experts in the same way there would be for an AI diagnostic. The "ground truth" is derived from engineering principles, material science standards, and established surgical practices for similar devices.
The "experts" involved would be materials scientists, biomechanical engineers, and regulatory specialists designing and evaluating the device and its testing protocols. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

Not Applicable. As there's no "ground truth" requiring expert consensus adjudication for clinical interpretations, no such method is described. The evaluation relies on objective engineering measurements against predefined standards.

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 not an AI/ML device, nor is it a device that is 'read' by human readers in the context of diagnostics. Therefore, an MRMC study is irrelevant.

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

Not Applicable. This is a physical medical device (implants and instruments), not an algorithm.

7. The type of ground truth used:

For this device, the "ground truth" is based on:
- Engineering Standards: Conformance to material standards (e.g., ASTM F136, ISO 5832-3 for Titanium alloy).
- Biomechanical Principles: The "engineering analyses" would establish that the device's mechanical properties (e.g., strength, fatigue resistance for fixation of osteotomies, fractures, arthrodeses) are appropriate for its intended use, likely by comparison to predicate devices' known performance.
- Regulatory Compliance: Meeting endotoxin limits through LAL testing.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical device and does not have a "training set" in the context of AI/ML.

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

Not Applicable.

In summary, this 510(k) submission for the Footmotion Plating System demonstrates substantial equivalence to predicate devices through engineering analyses, material testing, and confirmation of intended use rather than through clinical performance metrics and studies typical of AI/ML software.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.

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

September 8, 2017

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

Re: K171510

Trade/Device Name: Footmotion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 10, 2017 Received: August 14, 2017

Dear J.D. 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

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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.

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/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 (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

510(k) Number (if known)

K171510

Device Name

Footmotion Plating System

Indications for Use (Describe)

The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot 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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K171510 Page 1 of 3

Image /page/3/Picture/1 description: The image is a logo for Newclip-Technics. The logo features the letters "nc" in a circle, with an arrow pointing upwards in the color red. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.

510 (k) Summary for the FOOTMOTION PLATING SYSTEM 4.

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

Summary preparation date: May 22, 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 Plating System
Common Name:	Plates for fractures, osteotomies andarthrodesesScrews associatedInstrumentation associated
Product code:	HRS - Plate, Fixation, BoneHWC - Screw, Fixation, Bone
Classification Name:	Single/multiple component metallic bonefixation appliances and accessories.(21 CFR part. 888.3030)Smooth or threaded metallic bone fixationfastener (21 CFR part. 888.3040)

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Image /page/4/Picture/1 description: The image shows the logo for Newclip-Technics. The logo features the letters "nc" in a circle, with a red arrow pointing upwards replacing the right side of the "t". Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.

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

Footmotion Plating System of Newclip Technics (K161448) .

Secondary predicate or legally marketed devices which are substantially equivalent:

Ortholoc 3Di Hallux System of Wright Medical Technology (K120359) .

Reference device:

Alians Clavicle Range of Newclip Technics (K170310) .

4. Description of the device:	The Footmotion Plating System consists ofplates and screws, designed forarthrodeses, fractures and osteotomiesfixation and revision surgeries of the foot inadults.
	The implants of the Footmotion PlatingSystem will be provided non sterile forsterilization by health care professionalsprior to use or provided sterile by gammasterilization.The instruments of the Footmotion PlatingSystem will be provided non sterile forsterilization by health care professionalsprior to use.Single use kits (Initial F MTP) containimplants and instruments or instrumentsonly provided sterile by gammasterilization.
Materials:	Titanium alloy Ti-6Al-4V (conform to ASTMF136 and ISO 5832-3).
Function:	The implants of the Footmotion PlatingSystem are intended for arthrodeses,fractures and osteotomies fixation andrevision surgeries of the foot in adults.

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Image /page/5/Picture/1 description: The image shows a logo for "NEWCLIP-TECHNICS". The logo consists of a circle with the letters "nc" inside, and a red arrow pointing upwards is placed above the "c". Below the circle, the words "NEWCLIP-TECHNICS" are written in a simple, sans-serif font. The logo has a clean and modern design.

5. Substantial equivalence claimed to predicate devices:

The Footmotion Plating System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.

6. Intended use:

The Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.

7. Non-clinical Test Summary:

Engineering analyses have been conducted in comparison with the predicate devices.

LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of <20 EU/device.

8. Clinical Test Summary:

No clinical studies were performed.

9. Conclusions Non-clinical and Clinical:

Newclip Technics considers the Footmotion Plating System 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

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.