The ARIX Small Fragment System is intended for fixation of fractures, nonumons, replantations, and fusions pf small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

Device Description

The ARIX Small Fragment System is composed locking bone plate and locking screws that provide rigid fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The ARIX Small Fragment System is made of Unalloyed Titanium and Titanium Alloy (Ti-6A1-V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The bone plates consist of Straight, Triangle and T type which has different lengths and number of plate holes. The bone screws are compatible with K201656 ARIX Elbow System Bone Screw previously cleared. The screws are 2.8mm in diameter with self-tapping and provided with lengths from 8.0 to 70.0mm.

AI/ML Overview

This document describes the ARIX Small Fragment System, a medical device, and its acceptance criteria, but it does not include any information about a study proving the device meets acceptance criteria related to AI or algorithm performance.

The provided text is a 510(k) summary for the ARIX Small Fragment System, a metallic bone fixation appliance. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. This process typically involves comparing design, materials, indications for use, and performance, often through bench testing, rather than clinical efficacy studies or performance evaluations of AI algorithms.

Therefore, the following information you requested cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance (for an AI/algorithm device): This document discusses acceptance based on substantial equivalence to a predicate device and compliance with ASTM standards for metallic bone plates and screws. It does not provide acceptance criteria for an AI device.
Sample size used for the test set and the data provenance: Not applicable, as no AI performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does tell us about the device's "acceptance criteria" and "study":

The acceptance criteria for the ARIX Small Fragment System are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K063049 – Synthes Modular Mini Fragment LCP System) and compliance with relevant ASTM standards through bench testing.

Here's the relevant information from the document:

1. Acceptance Criteria and Reported Device Performance (as per the 510(k) process for this device type):

Acceptance Criterion (for substantial equivalence)	Reported Device Performance (as per the 510(k) summary)
Indication for Use (similar to predicate)	The ARIX Small Fragment System has equivalent indications for use as the predicate device. Intended for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments (e.g., hand, wrist, foot, and ankle).
Technological characteristics (similar to predicate)	Equivalent to predicate device. Bone plate design and materials are similar. Bone screws are previously cleared (K201656).
Operating principle (similar to predicate)	Equivalent to predicate device. Provides rigid fixation.
Design features (similar to predicate)	Equivalent to predicate device. Bone plates consist of Straight, Triangle, and T types with varying lengths and hole counts. Variable locking feature similar to predicate.
Performance (mechanical, similar to predicate)	Bench testing demonstrated equivalent mechanical performance to the predicate device.
Biocompatibility (materials meet standards)	Equivalent to predicate device. Made of Unalloyed Titanium and Titanium Alloy (Ti-6A1-V), meeting ASTM F67 and ASTM F136.
Materials (similar to predicate, meet standards)	Equivalent to predicate device. Made of Unalloyed Titanium and Titanium Alloy (Ti-6A1-V).
Method of sterilization (similar to predicate)	Equivalent to predicate device (implied standard method for such implants).
Compliance with ASTM F382 (for Metallic Bone Plates)	Bench tests conducted verified compliance.
Compliance with ASTM F543 (for Metallic Medical Bone Screws)	Bench tests conducted verified compliance.

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

Test Set: The document refers to "bench tests" performed on the device. It does not specify the sample size (number of plates/screws tested) or data provenance (e.g., date of testing, lab location).
Data Provenance: The tests were conducted internally by the manufacturer or a third-party lab to verify design specifications and compliance with ASTM standards.

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

Not applicable in the context of this type of bench testing. The "ground truth" here is compliance with engineering specifications and ASTM standards, which are objectively measured.

4. Adjudication method (for the test set):

Not applicable. Results from mechanical bench tests are typically objective measurements against predefined thresholds, not subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The document explicitly states: "No clinical studies were considered necessary and performed."

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

Not applicable. This is a physical bone fixation system, not an AI algorithm.

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" was defined by the design specifications of the device and the requirements of the ASTM standards (ASTM F382 and ASTM F543). The tests verified that the physical device met these objective, predefined engineering and performance criteria.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable.

Summary

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August 24, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K221920

Trade/Device Name: ARIX Small Fragment 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 30, 2022 Received: July 1, 2022

Dear Bora Kim:

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.

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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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 08/30/2023 See PRA Statement below.

510(k) Number (if known)

K221920

Device Name

ARIX Small Fragment 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)

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FORM FDA 3881 (6/20)

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510(k) Summary

[As required by 21 CRF 807.92]

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

June 30, 2022

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-ro 34-gil, Guro-gu, Seoul, 08378, Korea
Contact Name: Bora Kim / RA Specialist
- Telephone No.: +82 2 850 3533 ●
  - Fax No.: +82 2 850 3536 ●
- . Email Address: borakim@jeilmed.co.kr
Registration Number: 3004049923
. Name of Manufacturer: Same of Sponsor . Same of Sponsor Address:

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

Trade Name;	ARIX Small Fragment System
Common Name;	Bone Plate and Bone Screw
Classification Name;	Plate, Fixation, Bone / Screw, Fixation, Bone
Classification Panel;	Orthopedic
Classification Regulation;	21 CFR 888.3030
Product Code;	HRS(Primary), HWC
Device Class;	II

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

The legally marketed device(s) to which substantial equivalence is claimed is/are:

Predicate Device	K063049 – Synthes Modular Mini Fragment LCP System
Reference Device	K201656 – ARIX Elbow System, Jeil Medical Corporation

There are no significant differences between the subject device and the predicate devices that would

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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 Small Fragment System is made of Unalloyed Titanium and Titanium Alloy (Ti-6A1-V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

The bone plates consist of Straight, Triangle and T type which has different lengths and number of plate holes. The bone screws are compatible with K201656 ARIX Elbow System Bone Screw previously cleared. The screws are 2.8mm in diameter with self-tapping and provided with lengths from 8.0 to 70.0mm.

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

The ARIX Small Fragment System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

7. Technological Characteristics [21 CFR807.92(a)(6)]

Bone Plate: Based on a technical feature comparison, the subject device was found to be similar to all predicate device with regard to design and materials. The subject plates also have a variable locking feature, similar to the design used in the predicate device (K063049).

Bone Screw: ARIX Small Fragment Bone Screws consist of the previously cleared "ARIX Elbow System(K201656).

Non-Clinical Test Summary:

Bench tests were 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 F382, Standard Specification and Test Method for Metallic Bone Plates
ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws .

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

Clinical Test Summary:

No clinical studies were considered necessary and performed.

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8. Substantial Equivalence [21 CFR 807.92(b)(3)|

When compared to the predicate device (K063049), the ARIX Small Fragment System presented in this submission has equivalent:

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

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

In all respects, the ARIX Small Fragment System is substantially equivalent to the legally marketed device (K063049). The subject device has similar indications for use as the predicate device and has similar dimension and technical characteristics. Bench testing demonstrated equivalent mechanical performance. It is therefore concluded that the subject devices are considered substantially equivalent 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.