The ARIX Cannulated Screw System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid-and hind foot and ankle. Also, the ARIX Cannulated Screw System is internal fixation of the bones of hand and wrist. 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 Cannulated Screw System consists of cannulated screw with diameters raging from 2.3mm to 6.0mm. The cannulate screws are made of Titanium Alloy(Ti-6AI-4V), ASTM F136, which are widely used for surgical implants with well-known biocompatibility and provided nonsterile. This submission is to reclassify the previously approved device and to add 4.0mm diameter screws.

It also includes washer various manual surgical instruments, such as drill bit, screwdriver shaft, countersink, screwdriver handle, depth gauge, guide pin, cleaning stylet, dispenser, forceps and drill guide.

The ARIX Cannulated Screw 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

The provided text is a 510(k) summary for the ARIX Cannulated Screw System, which is a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through a study with the detailed elements you've requested.

Therefore, much of the information you've asked for, particularly regarding acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, is not available in this document.

However, I can extract the relevant information from the document:

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

The document doesn't define specific "acceptance criteria" in terms of performance thresholds for the device itself against clinical outcomes or diagnostic accuracy. Instead, it relies on demonstrating compliance with recognized standards and equivalence to predicate devices. The "reported device performance" is primarily the successful passing of these non-clinical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ASTM F543: Standard Specification and Test Method for Metallic Medical Bone Screws	The subject device complies with ASTM F543.
- Driving Torque Test	Test results demonstrated compliance.
- Torsion Test	Test results demonstrated compliance.
- Axial Pull-out Test	Test results demonstrated compliance.
Substantial Equivalence to Predicate Devices (K131311, K131566)	Found to be substantially equivalent in design, function, materials, operational principles, indications for use, technological characteristics, operating principle, design features, performance, biocompatibility, materials, and method of sterilization.
Sterilization validation per ISO 17665-1:2006	Sterilization method validated per ISO 17665-1: 2006.

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

Sample Size: Not applicable. The document describes non-clinical laboratory testing of bone screws, not a study involving a test set of data or patient samples.
Data Provenance: Not applicable. The testing was non-clinical and conducted in a laboratory setting. There is no mention of country of origin for data or whether it was retrospective or prospective.

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

Number of Experts: Not applicable. There was no "ground truth" to establish in the context of diagnostic accuracy or clinical outcomes for this device.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable. There was no test set requiring expert adjudication.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a bone screw, not an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable. This device is a physical medical implant, not an algorithm.

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

Type of Ground Truth: Not applicable. The "ground truth" for this device involved engineering specifications and biomechanical performance standards (ASTM F543).

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device is not an AI algorithm requiring a training set.

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

How Ground Truth for Training Set was Established: Not applicable.

Summary

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November 26, 2019

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 KR

Re: K192417

Trade/Device Name: ARIX Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 23, 2019 Received: September 4, 2019

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, M.P.H. 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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known) K192417

Device Name ARIX Canmulated Screw System

Indications for Use (Describe)

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)

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

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FORM FDA 3881 (7/17)

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10(k) Summary

s required by 21 CRF 8

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

25th October, 2019

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

Name of Sponsor: Jeil Medical Corporation 702·703·704·705·706·804·805·807·812·815-ho,55 Address: -Digital-ro34-gil, Guro-qu, Seoul, 08378, Korea
Contact Name: ● Sejin Ryu / RA Specialist
- +82 2 850 3583 Telephone No.: -
- Fax No.: +82 2 850 3536 -
- Email Address: rsj@jeilmed.co.kr -
Reqistration 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 Cannulated Screw System .
Common Name: Bone Screw ●
Classification Name: Screw, Fixation, Bone ●
. Classification Description: Smooth or threaded metallic bone fixation fastener
. Classification Panel: Orthopedic
Classification Regulation: 21 CFR 888.3040 ●
. Product Code: HWC
Device Class: ll

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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	K131311 - ARIX Foot SystemJeil Medical Corporation
Additional Predicates	K131566 - ARIX Hand SystemJeil Medical Corporation

There are no significant differences between the subject device and the predicate devices (K131311, K131566) that would adversely affect 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)]

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

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

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

Based on a technical feature comparison, the subject device was found to be similar to predicate devices with regard to design and materials. The subject device is substantially equivalent to the predicate device in terms of design, indication for use and size scope. (K131311, K131566)

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:

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Image /page/5/Picture/1 description: The image shows the logo and contact information for JEILMEDICAL. The logo is in orange and gray. The contact information includes the address, which is 702-703-704-705-706-804-805-807-812-815-ho, 55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Korea. The phone number is +82 2 850 3533 and the fax number is +82 2 850 3536.

. ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws
- -Drivina Torque Test
- -Torsion Test
- -Axial Pull-out Test

The results of this testing indicate that the ARIX Cannulated Screw 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 (K131311), the ARIX Cannulated Screw System presented in this submission has the same:

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

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

In all respects, the ARIX Cannulated Screw System is the equivalent of currently marketed devices. This device is made of same materials and has same dimension scope and characteristics. The ARIX Cannulated Screw System is titanium alloy that is used generally in this kind of bone screw. Based on the information submitted, ARIX Cannulated Screw System is substantially equivalent to the currently marketed predicate device.

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.