The EzRay Air W (Model: VEX-S300W) is an intra-oral dental X-ray system (extra-oral X-ray source system) intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

Device Description

The EzRay Air W (Model: VEX-S300W) is an intra-oral dental X-ray system intended for intra-oral imaging, It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The Xray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The system can be used with an imaging system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EzRay Air W (Model: VEX-S300W) intra-oral dental X-ray system. This document is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or performance studies that would typically involve acceptance criteria for an AI-powered device.

Therefore, the information requested, particularly regarding acceptance criteria for an AI device, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance, is not applicable to this submission. This is a submission for an X-ray imaging device itself, not an AI or software device that processes images.

However, I can extract the available performance information related to the device's technical specifications and how its performance was compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (Focus on X-ray system performance, not AI software):

Acceptance Criteria (related to X-ray performance)	Reported Device Performance (EzRay Air W)	Predicate Device (VEX-S100W) Performance	Reference Device (EzRay Air, VEX-P300) Similarities
Minimum Source to skin distance: >= 200 mm	200 mm	200 mm (default), 300 mm (option)	200 mm
X-ray field Size (default)	60 mm round	60 mm round	60 mm round
Focal spot	0.4 mm	0.4 mm	0.4 mm
Minimum half-value layer	1.5 mm Al	1.5 mm Al	1.5 mm Al
Electric Power Voltage	AC 100-240 V	AC 100-120 V / 200 -240 V	Rechargeable 22.2 V DC Li-ion polymer battery pack
Rated Current	10 A (at AC 250 V)	16 A (at AC 250 V)	N/A
Exposure time	0.05 - 0.5 seconds in 0.01 increments	0.04 - 2.0 seconds in 0.01 increments	0.05 - 0.5 seconds in 0.01 increments
Tube current	2.5 or 3.0 mA fixed	4 - 7 mA	2.5 mA fixed
Tube voltage	65 kVp fixed	50 - 70 kVp	60 or 65 kVp fixed
Operation mode	Manual Mode, Auto Mode	Manual Mode	Manual Mode, Auto Mode
Compliance with Safety Standards	IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31	IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31	IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31
Accuracy of loading factors	Met essential performance requirements (e.g., < kVp +10 %)	Met essential performance requirements (e.g., < kVp +10 %)	N/A
Reproducibility of Air KERMA	Met essential performance requirements	Met essential performance requirements	N/A
Leakage radiation test	Rendered satisfactory X-ray performance results	Rendered satisfactory X-ray performance results	N/A
Low Contrast & Line Pair performance	Met requirements	Met requirements	N/A

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

This document describes performance bench testing of the X-ray device itself, not a test set of patient data for an AI algorithm.
The performance testing focused on device specifications and physical measurements (e.g., focal spot to skin distance, accuracy of loading factors, reproducibility of Air KERMA, HVL, leakage radiation, low contrast & line pair performance).
Therefore, the concept of a "test set" in the context of data provenance (country of origin, retrospective/prospective) is not applicable. The "samples" would be the X-ray device units undergoing technical testing.

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):

This information is not applicable. Ground truth, in the context of image interpretation by experts, is not relevant to the technical performance testing of an X-ray generating device. The testing involved physical measurements and compliance with technical standards.

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

This information is not applicable. Adjudication methods are used to establish ground truth for human-interpretable data, which is not the focus of this device's performance testing.

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 an X-ray system, not an AI software. No MRMC study was conducted or required for this type of 510(k) submission.

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

This information is not applicable. The device is an X-ray system, not an AI algorithm.

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

This information is not applicable in the context of image interpretation. The "ground truth" for this device's performance revolves around objective physical measurements and compliance with established international and federal standards (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31) for X-ray generating equipment.

8. The sample size for the training set:

This information is not applicable. There is no mention of an AI algorithm or a training set for machine learning in this submission.

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

This information is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

January 24, 2017

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K163705

Trade/Device Name: EzRay Air W (Model: VEX-S300W) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: December 23, 2016 Received: December 29, 2016

Dear Mr. 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. 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 (reporting of medical device-related 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.

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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/Resourcesfor You/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.

Michael D. O'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K163705

Device Name EzRay Air W (Model: VEX-S300W)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 7 – 510(k) Summary

1. Special 510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

2. Date 510K Summary prepared: December 09, 2016

3. Administrative Information

Official Correspondent:	Dave Kim / Mtech GroupAddress: 8310 Buffalo Speedway, Houston, TX 77025Tel: +713-467-2607Fax: +713-464-8880Contact person: Mr. Dave Kim (davekim@mtech-inc.net)
510(k) Submitter:	VATECH Co., Ltd.Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, KoreaTel: +82-31-379-9492Fax: +82-31-379-9400Contact person: Daniel Kim / Manager (daniel.kim@vatech.co.kr)

4. Device Information

Type of 510(k) Submission:	Special
Trade or Proprietary Name:	EzRay Air W (Model: VEX-S300W)
Common or Usual Name:	Dental X-ray system
Regulation Classification:	Extraoral source X-ray system (21 CFR 872.1800)
Product Code:	EHD Class
of Device:	Class II
Panel:	Radiology

5. Predicate Device Information

Manufacturer:	VATECH Co., Ltd.
Predicate device:	VEX-S100W / K123493
Reference device:	EzRay Air (Model: VEX-P300) / K16063
Common or Usual Name:	Dental X-ray system
Regulation Classification:	Extraoral source X-ray system (21 CFR 872.1800)
Product Code:	EHD
Class of Device:	Class II
Panel:	Radiology

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6. Device Description

7. Indication for use

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8. Substantial Equivalence Chart
		Subject Device	Predicate Device	Reference Device
Device Name		EzRay Air W (Model: VEX-S300W)	VEX-S100W	EzRay Air (Model: VEX-P300)
Applicant Name		VATECH Co., Ltd.	VATECH Co., Ltd.	VATECH Co., Ltd.
510(k) Number		N/A	K123493	K161063
Device ClassificationName		Extraoral source x-ray system	Extraoral source x-ray system	Extraoral source x-ray system
Classification ProductCode		EHD	EHD	EHD
	Regulation Number	21 CFR 872.1800	21 CFR 872.1800	21 CFR 872.1800
Indications for Use		The EzRay Air W (Model: VEX-S300W) is an intra-oral dentalX-ray system (extra-oral X-raysource system) intended foruse by a trained and qualifieddentist or dental technicianfor both adult and pediatricsubjects for producingdiagnostic dental radiographsfor treatment of diseases ofthe teeth, jaw, and other oralstructures using intra-oralimage receptors.	The VEX-S100W is anextraoral source of X-rays, intended to beused for producingdiagnostic dentalradiographs fortreatment of disease ofthe teeth, jaw and oralstructures.	VEX-P300 is an extraoraldiagnostic dental X-raysource to produce X-rayimages using intraoralimage receptors. It isindicated for use by adentist or a dentaltechnician for both adultand pediatric patients.
	MinimumSource to skindistance	200 mm	1) 200 mm (default)2) 300 mm (option)	200 mm
Mechanical	X-ray field Size(default)	60 mm round	60 mm round	60 mm round
	Focal spot	0.4 mm	0.4 mm	0.4 mm
Minimum half-value layer		1.5 mm Al	1.5 mm Al	1.5 mm Al
	Electric PowerVoltage	AC 100-240 V	AC 100-120 V / 200 -240 V	Rechargeable 22.2 V DCLi-ion polymer batterypack
	Rated Current	10 A (at AC 250 V)	16 A (at AC 250 V)	N/A
	Exposure time	0.05 - 0.5 seconds in 0.01increments	0.04 - 2.0 seconds in0.01 increments	0.05 - 0.5 seconds in0.01 increments
Electrical	Tube current	2.5 or 3.0 mA fixed	4 - 7 mA	2.5 mA fixed
	Tube voltage	65 kVp fixed	50 - 70 kVp	60 or 65 kVp fixed
	Operation mode	Manual Mode, Auto Mode	Manual Mode	Manual Mode, Auto Mode
	AppliedStandard	IEC 60601-1,IEC 60601-1-3,IEC 60601-2-65,IEC 60601-1-2,21 CFR 1020.30, 1020.31	IEC 60601-1,IEC 60601-1-3,IEC 60601-2-65,IEC 60601-1-2,21 CFR 1020.30, 1020.31	IEC 60601-1,IEC 60601-1-3,IEC 60601-2-65,IEC 60601-1-2,21 CFR 1020.30, 1020.31

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9. Performance Data

- Summary of Performance Testing

The performance test for the subject device, EzRay Air W (Model: VEX-S300W) and the predicate device, VEX-S100W (K123493) confirmed that the focal spot to skin distance for both devices were longer than the minimum length of 20 cm. Accuracy of loading factors and reproducibility of Air KERMA for both X-ray systems also met the essential performance requirements (ex. < kVp +10 %). Both devices demonstrated similar performance outcomes in terms of HVL (half-value layer), limitation of the x-ray field and leakage radiation test which rendered satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements.

- Safety, EMC and Performance Data

The subject device complies with the safety and performance standards listed in the chart above, 'Substantial Equivalence Chart'. Test reports were provided to demonstrate conformance. All test results were complied with the requirements.

The safety and effectiveness of Auto Mode function have been demonstrated and confirmed by the previous 510k submission of the reference device, EzRay Air (Model: VEX-P300) (K16063).

10. The differences between the subject device and the predicate device

The EzRay Air W (Model: VEX-S300W) extraoral source x-ray system described in this special 510(k) is similar to the predicate device in its indications for use, design, technology, functions, and principle of operation. The differences between the subject device and the predicate device are as follows:

Electric Power Voltage, Rated Current Subject device- AC 100-240 V, 10 A (at AC 250 V) Predicate device- AC 100-120 V / 200 -240 V, 16 A (at AC 250 V) 2) Exposure time Subject device-0.05 - 0.5 seconds in 0.01 increments Predicate device- 0.04 - 2.0 seconds in 0.01 increments 3) Tube voltage (kVp), Tube current (mA) Subject device- 2.5 or 3.0 mA fixed, 65 kVp fixed Predicate device- 4 - 7 mA, 50 - 70 kVp 4) Dial Type Control Panel The control panel setting is done with a dial button which makes to increase an ease to use and reduce the time

for preparation. Operators need to control only one dial button for capture mode settings such as selection of Adult/Child & Tooth Mode. This control panel design is same with EzRay Air (Model: VEX-P300), the reference device (K161063)

Smart Position

The smart positioning makes extremely simple preparation. Operators only set the guideline following occlusal plane or frankfurt line. Then, it automatically detects an angle and a tooth. According to the setting by smart positioning, it changes exposure time as well. This feature is identical to EzRay Air (Model: VEX-P300), the reference device (K161063)

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The Performance Bench Testing demonstrated that these differences do not raise new questions of safety and effectiveness in comparison with the predicate device.

11. Conclusions

The subject device and the predicate device have similar indications for use and demonstrated similar design, technology, functions, and principle of operation. As demonstrated in the performance bench testing, X-ray performance and X-ray Safety and Image evaluation of the new and predicate devices were tested in accordance with Federal standard 21CFR Part 1020.30 and 31 as well as international standards such as IEC 60601-1, 60601-2-65, and 61223-3-4. Both the subject and predicate devices met the essential performance parameters including accuracy of loading factors, Reproducibility of Air KERMA, Focal Spot to Skin Distance, Leakage radiation, and Low Contrast & Line Pair performance requirements.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. VATECH Co., Ltd. concludes that EzRay Air W (Model: VEX-S300W) is substantially equivalent to predicate device as described herein.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.