ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.

Device Description

The ARIX Humerus System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Humerus System is consists of plates and screws. The ARIX Humerus 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 h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts and depth gauge. It also includes various manual surgical instruments, such as hand body, driver, drill bits, depth gauge, drill sleeve, forceps, drill guide block, sleeve handle and drill guide. The ARIX Humerus 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 is a 510(k) premarket notification for the ARIX Humerus System, a medical device for bone fixation. It does not describe a study involving device performance in terms of diagnostic accuracy or effects on human readers. Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/human reader performance.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and mechanical performance (bench testing), rather than clinical performance (e.g., diagnostic accuracy, reader improvement).

Here's why I cannot provide the specific details requested:

Type of Device: The ARIX Humerus System is a metallic bone fixation appliance (plates and screws). It is a surgical implant, not a diagnostic imaging device or an AI-powered image analysis tool.
Study Purpose: The studies mentioned (bench tests per ASTM F382 and F543) are mechanical performance tests designed to ensure the device's strength and fatigue resistance are equivalent to existing devices, not to evaluate diagnostic accuracy or how it impacts human interpretation of medical images.
"Acceptance Criteria" in this context: For this type of device, "acceptance criteria" are related to mechanical and material properties (e.g., bending strength, fatigue life, biocompatibility) rather than diagnostic metrics like sensitivity, specificity, or AUC.
Lack of AI/Reader Involvement: There is no mention of AI integration, human readers interpreting images, or any comparative effectiveness study involving human performance with and without AI assistance.

However, I can extract the information that is present in the document related to general device performance and regulatory requirements:

1. A table of acceptance criteria and the reported device performance (based on mechanical testing mentioned):

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance	Plate bending strength (ASTM F382)	No adverse difference from predicate device.	"The results of this testing indicate that the ARIX Humerus System is equivalent to predicate device."
Mechanical Performance	Plate bending fatigue (ASTM F382)	No adverse difference from predicate device.	"The results of this testing indicate that the ARIX Humerus System is equivalent to predicate device."
Material Properties	ASTM F67 (Unalloyed Titanium)	Compliance with standard.	Meets ASTM F67.
Material Properties	ASTM F136 (Titanium Alloy)	Compliance with standard.	Meets ASTM F136.
Sterilization	ISO 17665-1:2006	Achievement of SAL of 10-6.	Sterilization method validated per ISO 17665-1:2006.

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

The document does not specify sample sizes for mechanical testing. These tests are typically performed on a limited number of physical samples (e.g., plates and screws) to demonstrate compliance with standards.
Data provenance is not specified beyond being "bench tests." These are laboratory tests, not clinical data 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. This device does not involve expert interpretation or ground truth establishment in the context of diagnostic accuracy.

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

Not applicable. This is not a study involving human reader interpretation.

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 MRMC study was done. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical implant, not an algorithm.

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

For the mechanical tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices or relevant ASTM standards.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning algorithms requiring training sets.

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

Not applicable.

In summary, the provided document describes a 510(k) submission for a surgical implant, not an AI-powered diagnostic device. Therefore, questions related to AI performance, human reader studies, and diagnostic accuracy are not relevant to this document.

Summary

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Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Jeil Medical Corporation Sejin Ryu RA Specialist 702.703.704.705.706.804.805.807.812-ho. 55. Digital-ro34-gil. Guro-gu, Seoul, 152-728, Korea

Re: K172008

Trade/Device Name: ARIX Humerus 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: October 19, 2017 Received: October 26, 2017

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 (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

November 30, 2017

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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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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/0 description: The image shows the text 'K172008 Page 1 of 1'. This text likely represents a document identifier and page number. The document identifier is 'K172008', and the page number indicates that it is page 1 of 1, suggesting it is a single-page document.

702-703-704-705-706-804-805-807 Digital-ro34-gil, Guro-gu, 08378 Tel : +82 2 850 3533 / Fax : +82 2 850 3536

Indication for Use

510(k) Number (if known): K172008

Device Name: ARIX Humerus System

Indication for Use:

ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.

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)

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702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea Tel : +82 2 850 3533 / Fax : +82 2 850 3536

510(k) Summary

[As required by 21 CRF 807.92]

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

29 November 17

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, Digital-ro34-gil, Address: -Guro-gu, Seoul, 152-728, Korea
Contact Name: Sejin RYU / RA Specialist
- Telephone No.: +82 2 850 3500
- -Fax No.: +82 2 850 3536
- Email Address: rsj@jeilmed.co.kr
Registration No.: 3004049923
Manufacturer: Same as Sponsor O
- । Address: Same as Sponsor

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

Trade Name: ARIX Humerus System O
Common Name: Bone Plate and Bone Screw
Classification Name: Single/multiple component metallic bone fixation appliances and accessories
Orthopedic Classification Panel:
Classification Regulation: 21 CFR 880.3030 O
0 Product Code: HRS, HWC
Device Class: ll

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

The identified predicate devices within submission are shown as follows:

510(k) Number: K011815
Applicant: Synthes (USA)
SYNTHES LCP PROXIMAL HUMERUS PLATES ● Device Name:

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Image /page/4/Picture/1 description: The image shows the logo and contact information for JEIL MEDICAL CORPORATION. The logo is on the top left, and the address is listed below. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533, and the fax number is +82 2 850 3536.

510(k) Number: K171285 ●
Applicant: Jeil Medical Corporation
Common Name: Bone Plate. Bone Screw
0 Device Name: ARIX Diaphysis System

Reference Predicate Device -

510(k) Number: K151468
Applicant: Jeil Medical Corporation
0 Common Name: Bone Plate. Bone Screw
O Device Name: ARIX Wrist System
510(k) Number: K152158
O Applicant: Jeil Medical Corporation
0 Common Name: Bone Plate, Bone Screw
Device Name: ARIX Ankle System

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

	Plate	Cortical Screw	Locking Screw
Type/Configuration	35-PLHU series	35-SO-L series	35L-SO-L series40L-SA series45L-CO series
Material	ASTM F 67,Unalloyed Titanium	ASTM F 136,Titanium Alloy(Ti-6Al-4V)	ASTM F 136,Titanium Alloy(Ti-6Al-4V)

The ARIX Humerus System is consists of plates and screws. The ARIX Humerus 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 h are widely used for surgical implants with well-known biocompatibility.

The plates vary essentially through different lengths and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts and depth gauge.

It also includes various manual surgical instruments, such as hand body, driver, drill bits, depth gauge, drill sleeve, forceps, drill guide block, sleeve handle and drill guide.

The ARIX Humerus 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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702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil. Guro-gu. 08378. Korea Tel : +82 2 850 3533 / Fax : +82 2 850 3536

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

ARIX Humerus System is indicated for fractures, fracture dislocations, osteomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

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

ARIX Humerus System Bone Plate: 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 plates also have a locking feature, similar to the design used in the predicate device (K011815)

ARIX Humerus System Bone Screw: They share similar head, neck, and thread designs as the screws that are currently cleared under the predicate device (K011815 and K171285).

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, Standard Specification and Test Method for Metallic Bone Plates
ASTM F 543, Standard Specification and Test Methods for Metallic Medical Bone Screws ●

The following tests were performed with the predicate device:

Plate
- Bending strength test per ASTM F382
- Bending fatigue test per ASTM F382

The results of this testing indicate that the ARIX Humerus 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)(a) and 807.92]

When compared to the predicate device (K011815, K171285) the ARIX Ankle Distal Tibia System presented in this submission has the same:

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

9. Conclusion [21 CFR 807.92(b)(3)1

In all respects, the ARIX Humerus 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 Humerus, 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.