The ARIX Foot System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Device Description

The ARIX Foot System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Foot System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with various diameters, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 50 mm. ARIX Foot System is provided as blue color which is casted according to the anodizing technique while apply 5 V electric energy to the titanium. It also includes various manual surgical instruments, such as quide pins, drill bits and driver shafts, washers, drill sleeve, depth gauge, bender, cleaning stylet and screw driver handle. The ARIX Foot System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery.

AI/ML Overview

The provided text describes the regulatory clearance for the ARIX Foot System, a medical device for internal fixation, reconstruction, or arthrodesis of small bones. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML algorithm or diagnostic device.

The document specifically states under "Clinical Test Summary" that "No clinical studies were considered necessary and performed." This indicates that the regulatory clearance was based on non-clinical (bench) testing and substantial equivalence to existing devices, not on a study with human subjects, AI assistance, or expert ground truth determination.

Therefore, most of your requested information regarding acceptance criteria for an AI/ML device and the study proving it are not applicable to this document.

However, I can extract the information that is present:

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

Acceptance Criteria (Non-Clinical): The device must comply with ASTM F382-99 (Standard Specification and Test Method for Metallic Bone Plates) and ASTM F543-07 (Standard Specification and Test Methods for Metallic Medical Bone Screws).
Reported Device Performance: The bench tests (tensile strength test, bending strength test per ASTM F382) indicated that the ARIX Foot System is "equivalent to predicate device" and "met all design specifications."

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

Not applicable. This was a non-clinical, bench testing study on the device itself, not a study involving a test set of data (e.g., medical images) from patients.

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. Ground truth for an AI/ML device is not relevant here as there's no AI component or human interpretation being evaluated. The "truth" in this context is adherence to engineering standards.

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

Not applicable.

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. The document explicitly states "No clinical studies were considered necessary and performed." There is no mention of AI assistance or human readers.

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

No. This is not an algorithm-based device.

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

The "ground truth" equivalent in this non-clinical context would be the engineering specifications and ASTM standards (ASTM F382-99, ASTM F543-07). The device's performance was measured against these established standards.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable. There is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, possibly representing health and well-being. The logo is presented in black and white.

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

August 2, 2016

Jeil Medical Corporation Sejin Ryu RA Specialist #702 Kolon Science Valley 2nd, 55, Digital-ro 34, Guro-gu Seoul, 152-728 KOREA

Re: K161864 Trade/Device Name: ARIX Foot 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 Dated: July 6, 2016 Received: July 7, 2016

Dear Sejin Ryu:

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 Parts 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (21CFR 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 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,

VincentJ. Devlin -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by their address and contact information. The address is #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3535.

Indications for Use K161864 page 1 of 1

510(k) Number (if known): K161864

Device Name: ARIX Foot System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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Image /page/3/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by their address and contact information. The address is #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3535.

K161864 page 1 of 4

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(1)]

6 July 2016

2. Submitter's Information [21 CFR807.92(a)(1)]

	· Name of Sponsor:	Jeil Medical Corporation
--	--------------------	--------------------------

#702, Kolon Science Valley 2nd -Address: 811, Guro-dong, Guro-gu Seoul, 152-050, Korea
. Contact Name: Sejin RYU / RA Specialist
- Telephone No. : +82 2 850 3500 — Fax No. : +82 2 850 3525 ।
- Email Address : rsj@jeilmed.co.kr —
Registration Number: 3004049923
Same as Sponsor . Name of Manufacturer:
- Address: Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

●	Trade Name:	ARIX Foot System
●	Common Name:	Bone plates and screws
●	Classification Name:	Single/multiple component metallic bone fixationappliances and accessories
●	Classification Panel:	Orthopedic
●	Classification Regulation:	21 CFR 888.3030
●	Product Code:	HRS
●	Device Class:	II

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Image /page/4/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features a stylized smiley face in green, blue, gray, and orange, followed by the company name in orange and gray. Below the logo is the address: #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3535.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follows:

• 510(k) Number:	K063875
• Applicant:	Howmedica Osteonics Corp.
• Common Name:	Plate, Fixation, Bone
• Device Name:	Stryker Foot Plating System

510(k) Number: K131311 ●
Applicant: Jeil Medical Corporation
Common Name: Plate, Fixation, Bone

Device Name: ARIX Foot System
There are no significant differences between the Model ARIX Foot System and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as internal fixation components.

5. Description of the Device [21 CFR 807.92(a)(4)]

The ARIX Foot System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes, as follows:

	Plate	Cortical Screw	Locking Screw
	F35-Series	28-SO-L Series35-SO-L Series	28L-SO-L Series35L-SO-L Series
Type/ Configuration	CalcanealSeries	28-FC Series35-FC-Series28-SO-Series35-SO-Series	28L-HF Series35L-HF Series28L-SO-Series35L-SO-Series
Material	ASTM F67,Unalloyed Titanium	ASTM F 136,Titanium Alloy(Ti-6Al-4V)	ASTM F 136,Titanium Alloy(Ti-6Al-4V)

The ARIX Foot System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with various diameters, which are applied with the reconstruction locking screws together. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 50 mm.

ARIX Foot System is provided as blue color which is casted according to the anodizing technique while apply 5 V electric energy to the titanium.

General Information

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Image /page/5/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by their address and contact information. The address is #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3535.

K161864 page 3 of 4

It also includes various manual surgical instruments, such as quide pins, drill bits and driver shafts, washers, drill sleeve, depth gauge, bender, cleaning stylet and screw driver handle.

The ARIX Foot System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

6. Intended Use [21 CFR 807.92(a)(5)]

7. Technological Characteristics [21 CFR 807.92(a)(6)]

ARIX Foot System, Bone Plates: Based on a technical feature comparison, the subject device was found to be similar to all predicate devices with regard to design and materials. The subject plates also have a polyaxial locking feature, similar to the design used in the predicate device (K063875, K131311).

ARIX Foot System, Bone Screws: They share similar head, neck, and thread designs as the smaller screws that are currently cleared under the predicate device (K131311).

Non-Clinical Test Summary:

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

. ASTM F 382-99, Standard Specification and Test Method for Metallic Bone Plates
. ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws

The following tests were performed with the predicate device:

. Plates
- । Tensile strength test
- Bending strength test per ASTM F382 ।

The results of this testing indicate that the ARIX Foot System is equivalent to predicate device.

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Image /page/6/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo features the company name in a stylized font with a graphic of three colorful figures above it. Below the logo is the company's address: #702, Kolon Science Valley 2nd, 811 Guro-Dong, Guro-Gu, Seoul, 152-050 Korea. The telephone number is +82 2 850 3500 and the fax number is +82 2 850 3535.

Clinical Test Summary

No clinical studies were considered necessary and performed.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

When compared to the predicate device (K063875), the ARIX Foot System presented in this submission has the same:

Intended Use
Technological characteristics
o Operating principle
. Design features
. Performance
. Biocompatibility
. Materials
o Method of sterilization and sterility assurance level

9. Conclusion [21 CFR 807.92(b)(3)]

In all respects, the ARIX Foot System is the equivalent of currently marketed devices. This device is made of the same materials and has similar dimensions and characteristics. This device is manufactured from material of the unalloyed titanium and titanium alloy that is used generally in this kind of bone plate/screw system. This device, ARIX Foot System, is substantially equivalent in design, material, and function to the predicate device.

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.