VEX-P300 is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.

Device Description

VEX-P300, a portable dental X-ray system, operates on 22.2V DC supplied by a rechargeable Li-ion polymer battery pack. The portable x-ray system is an x-ray generating device which is mainly designed for dental examination (teeth and jaw). The portable X-ray system is composed of an x-ray generating part with an x-ray tube including a device controller, a power controller, a user interface, a beam limiting part, a back scattering shield, and an optional remote exposure switch. VEX-P300 is designed to diagnose tooth and jaw through X-ray exposure using intraoral image receptors.

AI/ML Overview

The document describes the EzRay Air (Model VEX-P300), an extraoral diagnostic dental X-ray source, and compares it to a predicate device, the NOMAD Pro X-ray System (K081664). The focus of the provided text is on demonstrating substantial equivalence to the predicate device, rather than defining specific acceptance criteria for a new AI/ML-driven diagnostic device. Therefore, much of the requested information regarding AI/ML-specific acceptance criteria, ground truth, and expert evaluation is not present in this document.

However, I can extract the information related to the device's technical performance and the studies conducted to establish its equivalence.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way one might expect for a diagnostic accuracy assessment of an AI device. Instead, it focuses on demonstrating compliance with federal and international standards for X-ray systems and verifying similar performance to the predicate device. The "acceptance criteria" here are implied by adherence to these standards and comparable performance to the predicate.

Performance Parameter / Criteria Implied by Standards	Reported Device Performance (EzRay Air VEX-P300)	Reported Performance (NOMAD Pro Predicate Device)	Compliance/Equivalence
Focal spot to skin distance	Longer than 20 cm	Longer than 20 cm	Met, Similar
	200 mm	210 mm	Similar
Accuracy of loading factors (e.g., kVp)	kVp ≤ ±10%	kVp ≤ ±10%	Met, Similar
Reproducibility of Air KERMA	Essential performance requirements met	Essential performance requirements met	Met, Similar
Half-Value Layer (HVL)	Similar performance outcomes	Similar performance outcomes	Similar
Limitation of the x-ray field	Similar performance outcomes	Similar performance outcomes	Similar
Leakage radiation test	Similar performance outcomes	Similar performance outcomes	Similar
Federal Standard Compliance (21CFR 1020.30 and 31)	Complied	Complied	Met, Similar
International Standard Compliance (IEC 60601-1, etc.)	Complied	Complied	Met, Similar
Backscatter radiation protection	165 mm dia., Pb-filled acrylic plastic	171.45 mm dia., Pb-filled acrylic plastic	Similar
Exposure time	0.05 - 0.5 seconds in 0.01 increments	0.02 - 1.00 seconds in 0.01 increments	Comparable, within typical device variations for this class
Tube voltage (kVp)	60 or 65 kVp fixed	60 kVp fixed	Comparable, within typical device variations for this class
Tube current (mA)	2.5 mA fixed	2.5 mA fixed	Similar

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

The document describes "Performance Bench Testing" conducted on the subject device (EzRay Air VEX-P300) and the predicate device (NOMAD Pro X-ray System). This testing involved physical measurements and evaluations of the X-ray systems' output and safety characteristics. It does not refer to a "test set" in the context of diagnostic images or data for an AI algorithm.

Sample size for test set: Not applicable in the context of images or diagnostic data for AI. The "test set" here refers to the devices themselves and the conditions under which they were tested. The assessment was done on one subject device and one predicate device.
Data provenance: Not applicable in the context of retrospective/prospective diagnostic data. The "data" comes from physical measurements and evaluations of the devices' X-ray output and safety in a laboratory or testing environment. The country of origin of the data is implied to be from the testing facilities that generated the compliance reports, likely associated with the manufacturer (VATECH Co., Ltd. in Korea) or accredited testing bodies.

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

This is not applicable as the study described is a technical performance and safety validation of an X-ray hardware device, not a diagnostic AI algorithm that requires expert-established ground truth for image interpretation. The "ground truth" for this type of device relates to adherence to physical parameters and safety standards.

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

Not applicable. The evaluation focused on objective physical measurements and compliance with technical standards, not on expert adjudication of diagnostic interpretations.

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 submission is for an X-ray device, not an AI algorithm. Therefore, no MRMC study or assessment of human reader performance with or without AI assistance was conducted or discussed.

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

Not applicable. This submission is for an X-ray device, not an AI algorithm.

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

The "ground truth" for this submission is based on established engineering principles, international and federal safety and performance standards for X-ray generating equipment (e.g., IEC 60601 series, 21 CFR 1020.30 and 1020.31), and the technical specifications of the predicate device. It's about verifiable physical properties and output, not diagnostic outcomes from patient data.

8. The sample size for the training set

Not applicable. This document pertains to the performance and safety testing of an X-ray hardware device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set mentioned or used in the context of this device submission.

Summary

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

September 1, 2016

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

Re: K161063

Trade/Device Name: EzRay Air (Model VEX-P300) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 19, 2016 Received: July 26, 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'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) K161063

Device Name EzRay Air VEX-P300

Indications for Use (Describe)

VEX-P300 is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.

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 5 – 510(k) Summary

1. Traditional 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: July 15, 2016

3. Administrative Information

Official Correspondent:	Dave Kim / Mtech GroupAddress: 12946 Kimberley Ln, Houston, TX 77079Tel: +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:	Traditional
Trade or Proprietary Name:	EzRay Air (Model: VEX-P300)
Common or Usual Name:	Portable 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:	Aribex, Inc.
Trade or Proprietary Name:	NOMAD Pro X-ray System
Common or Usual Name:	Portable X-ray System
Regulation Classification:	Extraoral source x-ray system (21 CFR 872.1800)
Product Code:	EHD
Class of Device:	Class II
Panel:	Radiology
510(k) Number:	K081664

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6. Device Description

7. Indication for use

VEX-P300 is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.

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8. Substantial Equivalence Chart

		Subject Device	Predicate Device
Device Name		EzRay Air(Model: VEX-P300)	NOMAD Pro X-ray System
Applicant Name		VATECH Co., Ltd.	Aribex, Inc.
510(k) Number		N/A	K081664
	Device Classification Name	Extraoral source x-ray system	Extraoral source x-ray system
	Classification Product Code	EHD	EHD
Regulation Number		21 CFR 872.1800	21 CFR 872.1800
Indications for Use		VEX-P300 is an extraoral diagnosticdental X-ray source to produce X-rayimages using intraoral imagereceptors. It is indicated for use by adentist or a dental technician forboth adult and pediatric patients.	The NOMAD Pro X-ray System isindicated for use only by a trainedand qualified dentist or dentaltechnician for both adult andpediatric subjects as an extraoraldiagnostic dental X-ray source toproduce X-ray images using intraoralimage receptors.
	Size (L x W x H)	280 x 165 x 296 mm	266.7 x 133.35 x 304.8 mm
Mechanical	Source to skindistance	200 mm	210 mm
	X-ray field Size	60 mm round	60 mm round
	User Interface	Jog dial for operating mode selection.Additionally, several user-selectablepreset times with patient size andtooth selection icons on a displaymodule.	Up-down buttons for exposure timeselection, with timer display.Additionally, several user-selectablepreset times with patient size, image-receptor type, and tooth selectionicons on an LCD display.
	Backscatterradiationprotection	165 mm dia., Pb-filled acrylic plastic,Back Scattering shield	171.45 mm dia. Pb-filled acrylicplastic scatter shield
	Exposure Switch	Exposure button on the handset	Trigger on Handset
	Tube headmounting	Handheld	Handheld
Electrical	Energy source	Rechargeable 22.2 V DC Li-ionpolymer battery pack	Rechargeable 22.2 V DC LithiumPolymer battery pack
	Exposure time	0.05 - 0.5 seconds in 0.01 increments	0.02 - 1.00 seconds in 0.01increments
	mA	2.5 mA fixed	2.5 mA fixed
	kVp	60 or 65 kVp fixed	60 kVp fixed
	Waveform	Constant Potential (DC)	Constant Potential (DC)
	Applied Standard	IEC 60601-1, IEC 60601-1-3, IEC60601-2-65, IEC 60601-1-2, 21 CFR1020.30, 1020.31	IEC 60601-1, EN 60601-1, EN 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, 21CFR 1020.30, 1020.31

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9. Performance Data

- Summary of Performance Testing

The performance test for the subject device, VEX-P300 and the predicate device, NOMAD Pro X-ray System (K081664) 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, 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.

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

The VEX-P300 Portable X-ray system described in this traditional 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:

① Device Size Subject device-280 x 165 x 296 mm Predicate device-266.7 x 133.35 x 304.8 mm હી ટેટા

Subject device-200 mm Predicate device-210 mm

3 Backscatter radiation protection size (diameter):

Subject device-165 mm dia. Predicate device-171.45 mm dia.

(4) Exposure time Subject device-0.05 - 0.5 seconds in 0.01 increments Predicate device-0.02 - 1.00 seconds in 0.01 increments

ട്ര Tube voltage (kVp), Tube current(mA)

Subject device-2.5 mA fixed, 60 or 65 kVp fixed Predicate device-2.5 mA fixed, 60 kVp fixed

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

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including accuracy of loading factors, Reproducibility of Air KERMA, Focal Spot to Skin Distance, Leakage radiation, and Low Contrast & Line Pair performance requirements.

Quality assurance procedures are adhered to, and the specifications and functional requirements were met as the test results indicated.

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 VEX-P300 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.