The ARIX Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humerus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.

Device Description

The ARIX Elbow System is consist of proximal radius plate, ulna olecranon plate, distal humerus plate and bone screw. The ARIX Elbow System is made of Unalloyed 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 type and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments such as drill bits, drill sleeve and sleeve handle, driver, depth gauge, bender, handle, driver shafts and depth gauge. The ARIX Elbow 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. 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.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the "ARIX Elbow System," which is a metallic bone fixation appliance. It is important to note that this document is for a physical medical device (bone plates and screws), not a software or AI-based diagnostic device. Therefore, the questions about acceptance criteria, study design for AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment, etc.), and training/test set sample sizes as typically applied to AI/ML devices do not directly apply in the context of this 510(k) summary.

However, I can extract information related to the device's performance justification based on the provided document, adapting your questions to fit the context of a physical orthopedic implant.

Here's an analysis based on the provided text, indicating where the requested information is not applicable for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" and "performance" are typically demonstrated through adherence to recognized national/international standards for mechanical properties and biocompatibility, and through comparison to predicate devices.

Acceptance Criteria (Demonstrated via Standards & Benchmarking)	Reported Device Performance (Summary of Test Results)
Biocompatibility: Meet requirements for materials used in surgical implants to ensure no adverse biological reactions (implied by material selection meeting ASTM standards).	The ARIX Elbow System is made of Unalloyed 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 Alloy for Surgical Implant Applications). These are widely used, biocompatible materials for surgical implants.
Mechanical Strength & Performance (Bone Screws): Must meet specified mechanical properties for metallic medical bone screws (e.g., torsional strength, pull-out strength, bending strength).	Non-Clinical Test was conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with ASTM F543 (Standard Specification and Test Method for Metallic Medical Bone Screws). The results indicate that the ARIX Elbow System is equivalent to the predicate device in terms of screw performance.
Mechanical Strength & Performance (Bone Plates): Must meet specified mechanical properties for metallic bone plates (e.g., fatigue strength, static bending strength, stiffness).	Non-Clinical Test was conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates). The results indicate that the ARIX Elbow System is equivalent to the predicate device in terms of plate performance.
Sterilization Efficacy: Demonstrate that the recommended sterilization method achieves the required sterility assurance level (SAL).	The sterilization method (autoclave) in the instruction 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) to reach a SAL of 10-6.
Substantial Equivalence: Demonstrate that the device is as safe and effective as a legally marketed predicate device, with similar indications for use, technological characteristics, operating principles, design features, performance, biocompatibility, materials, and method of sterilization. This is a core regulatory acceptance criterion for 510(k) clearance.	The ARIX Elbow System has the same: Indication for Use, Technological characteristics, Operating principle, Design features, Performance, Biocompatibility, Materials, and Method of sterilization when compared to the predicate devices (K090053, K103332, K112560 and K063049). It is concluded to be substantially equivalent in design, material, and function. "There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product."

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

Sample Size: Not applicable in the traditional sense of a "test set" for an AI/ML algorithm. The "test" here refers to non-clinical (bench) testing of the physical device components. For non-clinical tests, the sample size would typically be a small number of representative devices tested according to the respective ASTM standards (e.g., typically N=5 to 10 for mechanical tests, per standard guidelines). The document does not specify the exact number of units tested for each non-clinical test.
Data Provenance: Not applicable for a non-AI physical device. The "data" comes from controlled laboratory bench tests adhering to international standards.

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

Not Applicable. This is a physical orthopedic implant. There is no "ground truth" in the context of expert review for an AI/ML diagnostic output. Device performance is assessed via objective, quantifiable mechanical and material properties or sterilization efficacy, measured against established standards.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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 a physical device, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable in the AI/ML context. For this device, "ground truth" or verification is based on:
- Objective Measurement against Bending/Torsional/Tensile Strength Standards: Mechanical properties (e.g., measured force, displacement, cycles to failure, pull-out strength, fatigue life) determined via bench testing per ASTM F543 and F382.
- Material Composition/Purity Specifications: Verification that the materials meet ASTM F67 and F136.
- Sterility Assurance Level (SAL): Verification that the sterilization process achieves a 10^-6 SAL per ISO 17665-1.
- Comparison to Predicate Device: Demonstrating similar characteristics and performance to already cleared devices.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not Applicable. See point 8.

Summary of Device Justification from the Document:

The ARIX Elbow System demonstrated its "acceptance criteria" and "performance" through:

Material Compliance: Use of medical-grade titanium alloys (Ti-6AL-4V) meeting ASTM F67 and F136, indicating known biocompatibility.
Non-Clinical Bench Testing: Demonstrated compliance with ASTM F543 (for screws) and ASTM F382 (for plates), ensuring the devices meet established mechanical performance standards for bone fixation. The results indicated equivalence to the predicate device.
Sterilization Validation: Validation of the recommended autoclave sterilization method to achieve the required 10^-6 SAL per ISO 17665-1, ensuring the product can be safely prepared for surgery.
Substantial Equivalence: A direct comparison to identified predicate devices (Medartis AG APTUS systems and Synthes Modular Mini Fragment LCP System) confirmed similarities in indications for use, technological characteristics, operating principle, design features, expected performance, biocompatibility, materials, and sterilization methods. No significant differences affecting safety or effectiveness were identified.
No Clinical Studies: The submission explicitly states, "No clinical studies were considered necessary and performed," which is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.

Summary

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September 15, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Jeil Medical Corporation Sejin Ryu RA Specialist 702,703,704,705,706,804,805,807,812,815-ho 55 Digital-ro 34-gil, Guro-gu Seoul, 08378 Korea

Re: K201656

Trade/Device Name: ARIX Elbow 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: June 10, 2020 Received: June 18, 2020

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. 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,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K201656

Device Name

ARIX Elbow System

Indications for Use (Describe)

The ARIX Elbow System is intended for fractures and osteotomies of proximal radius, ulnar olecranon and distal humerus. The ARIX Proximal Radius Plate is intended for use in proximal radial fractures and osteotomies. The ARIX Olecranon Plate is intended for use in particular for ulna fractures and osteotomies. The ARIX Distal Humenus Plate is intended for use in distal humerus fractures, osteotomies and non-unions.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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PSC Publishing Services (101)-443-6740 EST

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510(k) Summary

[As required by 21 CRF 807.92]

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

August 13, 2020

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

Jeil Medical Corporation . Name of Sponsor: Address: 702·703·704·705·706·804·805·807·812·815-ho,55 -Digital-ro34-gil, Guro-gu, Seoul, 08378, Korea
Contact Name: Sejin Ryu / RA Specialist
- Telephone No.: +82 2 850 3583 -
- Fax No.: +82 2 850 3536
- -Email Address: rsj@jeilmed.co.kr
Registration Number: 3004049923
. Name of Manufacturer: Same as Sponsor . Address: Same as Sponsor

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

•	Trade Name;	ARIX Elbow System
•	Common Name;	Plate, Fixation, Bone (Primary)Screw, Fixation, Bone
•	Classification Name;	Single/multiple component metallic bone fixationappliances and accessories
•	Classification Panel;	Orthopedic
•	Classification regulation;	21 CFR 888.3030 (Primary),21 CFR 888.3040
•	Product code;	HRS (Primary),HWC
•	Device Class:	II

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

The identified predicate device within this submission are shown as follow;

Primary Predicate	K090053 – APTUS 2.0 Radial Head SystemMedartis AG
Additional Predicates	K103332 – APTUS Ulna PlatesMedartis AGK112560 – APTUS Distal Humerus SystemMedartis AGK063049 – Synthes Modular Mini Fragment LCP SystemSynthes (USA)
Reference Device	K170705 – ARIX Wrist System, Jeil Medical CorporationK170313 – ARIX Ankle Distal Tibia System, Jeil Medical CorporationK171285 – ARIX Diaphysis System, Jeil Medical CorporationK172008 – ARIX Humerus System, Jeil Medical Corporation

There are no significant differences between the subject device 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 Elbow System is consist of proximal radius plate, ulna olecranon plate, distal humerus plate and bone screw.

The ARIX Elbow System is made of Unalloyed 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 type and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments such as drill bits, drill sleeve and sleeve handle, driver, depth gauge, bender, handle, driver shafts and depth gauge.

The ARIX Elbow 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. 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.

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6. Indication for use [21 CFR 807.92(a)(5)]

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

Bone Plate: Based on a technical feature comparison, the subject device was found to be similar to predicated devices with regard to design and materials. The subject plates also have locking feature, similar to the design used in the predicate device. (K090053, K103332, K112560)

Bone Screw: They share similar head, neck, and thread designs as the screws that are previously cleared under the predicate devices. (K063049, K170705)

Non-Clinical Test Summary:

Non-Clinical Test was conducted to verify that the subject device met all design specifications. The test result demonstrated that the subject device complies with the following standards:

ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws
ASTM F382, Standard Specification and Test Method for Metallic Bone Plates

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

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 devices (K090053, K103332, K112560 and K063049), the ARIX Elbow System presented in this submission has the same:

Indication for Use
Technological characteristics
Operating principle ●
Design features
. Performance
Biocompatibility ●
Materials
Method of sterilization

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

In all respects, the ARIX Elbow 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 titanium that is used generally in this kind of bone plate/screw system. This device, ARIX Elbow, 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.