The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Ankle System is made of Pure 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 cortical screws, locking screws diameter is 3.5mm lengths is from 10mm to 70mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc., The ARIX Ankle System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery.

AI/ML Overview

This document describes a 510(k) premarket notification for the ARIX Ankle System, a device for internal fixation of the distal fibula. The submission aims to demonstrate substantial equivalence to a predicate device, the VariAX™ Distal Fibula Plate (K081284).

Here's a breakdown of the requested information based on the provided text:

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

The document doesn't explicitly define "acceptance criteria" with specific numerical targets in the same way a clinical trial might for a diagnostic device. Instead, the performance is reported against established ASTM standards for metallic bone plates and screws. The "acceptance criteria" are implied to be conformance with these standards and equivalency to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Plates
Conformance to ASTM F382-99: Standard Specification and Test Method for Metallic Bone Plates	Dimension test: Complied with design specifications.
	Single Cycle Bending test: Demonstrated compliance with ASTM F382.
	Bending Fatigue test: Demonstrated compliance with ASTM F382.
Screws
Conformance to ASTM F543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws	Dimension test: Complied with design specifications.
	Driving torque test: Demonstrated compliance with ASTM F543-07.
	Axial pull-out test: Demonstrated compliance with ASTM F543-07.
	Torsion test: Demonstrated compliance with ASTM F543-07.
Substantial equivalence to predicate device (K081284) in design, function, materials, and operational principles.	The test results indicate that the ARIX Ankle System is equivalent to predicate devices.

2. Sample size used for the test set and the data provenance:

Sample size: The document does not specify the sample size used for the bench tests. It mentions "plates" and "screws" in general, implying a set of each type was tested, but no numbers are provided.
Data provenance: The data provenance is from non-clinical bench testing conducted to verify that the proposed device met design specifications and complied with ASTM standards. There is no information regarding country of origin for the test data, nor is it retrospective or prospective in the clinical sense, as no human data was involved.

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

This information is not applicable as the study was non-clinical bench testing. Ground truth in this context would be defined by the specifications of the ASTM standards and the design specifications of the device, not expert consensus.

4. Adjudication method for the test set:

This information is not applicable as the study was non-clinical bench testing. Performance was assessed against objective engineering standards and specifications.

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:

This information is not applicable. The device is a physical bone fixation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant.

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

This information is not applicable. The device is a physical bone fixation system, not an algorithm.

7. The type of ground truth used:

The ground truth used for the non-clinical tests was based on:

ASTM Standards: Specifically, ASTM F 382-99 for metallic bone plates and ASTM F 543-07 for metallic medical bone screws.
Design Specifications: The device was tested to verify it met its "design specifications."
Predicate Device Characteristics: The performance and characteristics were compared to the predicate device to establish substantial equivalence.

8. The sample size for the training set:

This information is not applicable. There was no "training set" in the context of an AI/machine learning model, as this is a physical medical device.

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

This information is not applicable. There was no training set or ground truth in the AI/machine learning sense.

Summary

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September 28, 2015

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

Jeil Medical Corporation Jiwon KANG RA Specialist 702•703•704•705•706•804•805•807•812-ho, 55, Digital-ro34-gil, Guro-gu Seoul-City, 152-728 Republic of KOREA

Re: K152158

Trade/Device Name: ARIX Ankle System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: August 26, 2015 Received: August 27, 2015

Dear Ms. Jiwon KANG:

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

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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 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 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 yours.

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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Image /page/2/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo consists of a colorful abstract graphic on the left, followed by the word "JEIL" in orange, and then the words "MEDICAL CORPORATION" in gray, stacked on top of each other. The abstract graphic is made up of several different colored shapes, including green, blue, gray, and orange.

702-703-704-705-706-804-805-807-812 10. 55. Digital-ro34-gil, Guro-gu, 152-728, Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535

Indication for Use

510(k) Number (if known):

Device Name: ARIX Ankle System

Indication for Use:

The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.

Prescription Use X (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. The logo consists of a stylized graphic to the left of the company name. The graphic includes a gray crescent shape, a green circle, and a blue circle. The company name is written in orange and gray.

702-703-704-705-706-804-805-807 Digital-ro34-gil, Guro-qu. 152-728, Korea Tel : +82 2 850 3500 / Fax : +82 2 850 3535

510(k) Summary

[As required by 21 CRF 807.92]

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

21 August 2015

2. Submitter's Information [21 CFR 807.92(a)(1)]

. Name of Sponsor: Jeil Medical Corporation
- 702-703-704-705-706-804-805-807-812-ho, 55 -Address: Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
Contact Name: Jiwon KANG (Ms.) / RA Specialist o
- Telephone No. : +82 2 850 3500 =
- Fax No. : +82 2 850 3525 =
- -Email Address : jwkang@jeilmed.co.kr
. Registration Number: 3004049923
Name of Manufacturer: Same as Sponsor o
- Same as Sponsor -Address:

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

o Trade Name: ARIX Ankle System
Common Name: . Bone plates and screws
. Classification Name: Single/multiple component metallic bone fixation appliances and accessories
. Classification Panel: Orthopedic
Classification Regulation: 21 CFR 888.3030 ●
KTT Product Code: .
. Device Class: =

General Information

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Image /page/4/Picture/0 description: The image shows the logo for JEIL Medical Corporation. The logo consists of a colorful abstract design on the left, followed by the text "JEIL" in a bold, sans-serif font. To the right of "JEIL" is the word "MEDICAL" stacked on top of the word "CORPORATION", both in a smaller, lighter font.

702-703-704-705-706-804-805-807-812 Digital-ro34-qil, Guro-qu, 152-728, Korea Tel : +82 2 850 3500 / Fax : +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 follow;

510(k) Number: . K081284
0 Applicant: HOWMEDICA OSEONICS CORP.
. Common Name: plate, fixation, bone
VariAXTM Distal Fibula Plate Device Name: e

There are no significant differences between the Model ARIX Ankle System and the predicate devices 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 Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follow:

	Straight Plate	Lateral Plate	Cortical Screw	Locking Screw
TypeConfiguration	35-DLST Series	35-DLFI Series	35-HF Series	35L-HF Series
Material	ASTM F 67Pure Titanium	ASTM F 67Pure Titanium	ASTM F 136Titanium Alloy(Ti-6Al-4V)	ASTM F 136Titanium Alloy(Ti-6Al-4V)

The ARIX Ankle System is made of Pure 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 cortical screws, locking screws diameter is 3.5mm lengths is from 10mm to 70mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc., The ARIX Ankle 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.

This device performance is not adversely affected by aging or storage conditions since this device is to be sterilized at the hospital before use and also to be single use.

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Image /page/5/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic to the left of the text. The graphic consists of several curved shapes in different colors, including blue, green, gray, and orange. To the right of the graphic, the text "JEIL" is displayed in a large, bold font, with the word "MEDICAL" above the word "CORPORATION" in a smaller font.

702-703-704-705-706-804-805-807 Digital-ro34-gil, Guro-gu, 152-728, Tel : +82 2 850 3500 / Fax : +82 2 850 3535

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

The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.

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

ARIX Ankle 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 poly axial locking feature, similar to the design used in the predicate devices (K081284 ).

ARIX Ankle System, Bone Screws: They share similar head, neck and thread designs as the smaller screws that are currently cleared under the predicate devices (K081284).

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 9 Screws

The following tests were performed with the predicate devices:

· Plates
- Dimension test -
- -Single Cycle Bending test per ASTM F382
- Bending Fatigue test per ASTM F382 」
Screws .
- Dimension test -
- -Driving torque test per ASTM F543-07
- Axial pull-out test per ASTM F543-07 _
- Torsion test per ASTM F543-07 l

The results of this testing indicate that the ARIX Ankle System is equivalent to predicate devices.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

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Image /page/6/Picture/0 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 152-728, Korea. The telephone number is +82 2 850 3500, and the fax number is +82 2 850 3535.

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

When compared to the predicate devices (K081284), the ARIX Ankle System presented in this submission has the same;

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

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

In all the respects, the ARIX Ankle 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 Pure Titanium and Titanium Alloy, Unalloyed titanium and Wrought titanium alloy that is used generally in this kind of bone plate/screw system. This device, ARIX Ankle System, is substantially equivalent in design, material, and function to the predicate devices.

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.