The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray 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 the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

Device Description

The EzRay Air 2 Wall (Model: VEX-S350W) is a dental X-ray system intended for intra-oral imaging. It consists of an X-ray generator, X-ray controller, beam limiting device, operation panel, and mechanical arm. The X-ray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The functions of the VEX-S350W intra-oral system are supported by software (firmware). The software is based on the predicate device and is of Moderate level of concern. 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 2 Wall (Model: VEX-S350W) dental X-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (EzRay Air Wall (Model: VEX-S300W) / K163705) rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested details regarding acceptance criteria for AI/ML performance, study design (sample size, ground truth, expert adjudication, MRMC studies), training set specifics, and effect sizes of human reader improvement with AI assistance are not present in this document. The document primarily addresses the safety and performance of an X-ray imaging system itself, not an AI component.

However, based on the information provided regarding the device's performance testing for its X-ray imaging capabilities, here's an attempt to extract and reframe the information to fit the structure of your request where possible, acknowledging the limitations due to the nature of the submitted document:

Device: EzRay Air 2 Wall (Model: VEX-S350W) - Dental X-ray System

The provided document describes the acceptance criteria and performance study for the EzRay Air 2 Wall, a dental X-ray system. It focuses on the device's imaging capabilities, not an integrated AI component. Therefore, the details requested for AI/ML device validation are not applicable or available in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this X-ray system are based on compliance with Federal Standards and International Standards related to X-ray performance and safety. The performance is demonstrated through various tests.

Acceptance Criteria (Standard / Requirement)	Reported Device Performance (EzRay Air 2 Wall (VEX-S350W))
Minimum Source to Skin Distance	Longer than the minimum length of 20 cm
Accuracy of Loading Factors	Met essential performance requirements (e.g., < kVp +10 %)
Reproducibility of Air KERMA	Met essential performance requirements
HVL (Half-Value Layer)	Rendered satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements
Limitation of X-ray Field Test	Rendered satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements
Electrical Safety (IEC 60601-1)	Complies / Test results complied with requirements
Mechanical Safety (IEC 60601-1-3)	Complies / Test results complied with requirements
Performance (IEC 60601-2-65)	Complies / Test results complied with requirements
EMC (IEC 60601-1-2)	Complies / Test results complied with requirements
Image Performance - Low Contrast	Evaluated according to IEC standard through performance bench testing; demonstrated.
Image Performance - Line Pair	Evaluated according to IEC standard through performance bench testing; demonstrated.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of number of patient images or subjects. Instead, the testing refers to performance bench testing of the device itself.

Sample Size: Not applicable in the traditional sense of patient data. The "test set" consists of the device hardware and its operational parameters.
Data Provenance: The testing appears to be conducted in a laboratory or engineering environment to meet regulatory standards. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. For a device like an X-ray system, "ground truth" typically refers to the physical and electrical parameters of the device, measured by calibrated equipment and verified against engineering specifications, rather than human expert interpretation of clinical images.

4. Adjudication Method for the Test Set

Not applicable. The testing described is objective measurement of physical and electrical parameters of the X-ray device itself against predefined performance requirements and standards. There is no human interpretation or adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This device is an X-ray system, and the submission is for its substantial equivalence, not for an AI/ML algorithm that assists human readers. Therefore, there's no mention of how human readers improve with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This is an X-ray imaging device, not an AI algorithm. Its performance is inherent to its design and function.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by regulatory standards and engineering specifications. This includes:

Physical measurements (e.g., source to skin distance, focal spot size, X-ray field size).
Electrical measurements (e.g., tube voltage, tube current, exposure time, accuracy of loading factors).
Radiological measurements (e.g., Half-Value Layer, Air KERMA).
Image quality metrics (Low Contrast and Line Pair performance), which are objectively measured using phantoms according to IEC standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As noted above, this is an X-ray imaging device, not an AI/ML system requiring a training set with established ground truth from clinical data.

Summary

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October 26, 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin Street, Suite 610 HOUSTON TX 77054

Re: K223058

Trade/Device Name: EzRay Air 2 Wall (Model: VEX-S350W) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: September 22, 2022 Received: September 30, 2022

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. 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 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

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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 mediation-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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223058

Device Name EzRay Air 2 Wall (Model: VEX-S350W)

Indications for Use (Describe)

The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

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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X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K223058

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: October 20, 2022

3. Administrative Information

Official Correspondent:	Dave Kim / Mtech Group
	Address: 7505 Fannin Street, Suite 610,
	Houston, TX 77025
	Tel: +713-467-2607
	Contact 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, Korea
	Tel: +82-31-379-9492
	Fax: +82-31-379-9400
	Contact person: Daniel Kim / Manager (daniel.kim@vatech.com)

Device Information

Type of 510(k) Submission:	Special
Trade or Proprietary Name:	EzRay Air 2 Wall (Model: VEX-S350W)
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:	EzRay Air Wall (Model: VEX-S300W) / K163705
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
Device Name		EzRay Air 2 Wall (Model: VEX-S350W)	EzRay Air Wall (Model: VEX-S300W)
Applicant Name		VATECH Co., Ltd.	VATECH Co., Ltd.
	510(k) Number	N/A	K163705
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		The EzRay Air 2 Wall (Model: VEX-S350W) is a dental X-ray systemintended for use by a trained andqualified dentist or dental technicianfor both adult and pediatric subjectsfor producing diagnostic dentalradiographs for the treatment ofdiseases of the teeth, jaw, and otheroral structures using intra-oral imagereceptors.	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 andqualified dentist or dental technicianfor both adult and pediatric subjectsfor producing diagnostic dentalradiographs for treatment of diseasesof the teeth, jaw, and other oralstructures using intra-oral imagereceptors.
	Minimum Source toskin distance	200 mm	200 mm
Mechanical	X-ray field Size(default)	60 mm round	60 mm round
	Focal spot	0.4 mm	0.4 mm
	Minimum half-value layer	1.5 mm Al	1.5 mm Al
	Electric PowerVoltage	AC 100-240 V	AC 100-240 V
	Rated Current	10 A (at AC 250 V)	10 A (at AC 250 V)
Electrical	Exposure time	0.05 - 2.0 seconds in 0.01increments	0.05 - 0.5 seconds in 0.01increments
	Tube current	5.0 mA fixed	2.5 or 3.0 mA fixed
	Tube voltage	65 / 70 kVp fixed	65 kVp fixed
	Operation mode	Manual Mode	Manual Mode, Auto Mode
	Applied Standard	IEC 60601-1,IEC 60601-1-3,IEC 60601-2-65,IEC 60601-1-2,	IEC 60601-1,IEC 60601-1-3,IEC 60601-2-65,IEC 60601-1-2,
		21 CFR 1020.30, 1020.31	21 CFR 1020.30, 1020.31

8. Substantial Equivalence Chart

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9. Performance Data

- Summary of Performance Testing

The performance test for the subject device, EzRay Air 2 Wall (Model: VEX-S350W) and the predicate device, VEX-S300W (K163705) confirmed that the focal spot to skin distance for both devices was 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) and limitation of the x-ray field 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'.

Electrical, mechanical, environmental safety, and performance testing according to standard IEC 60601-1(Ed. 3.1, 2012), IEC 60601-1-3 (Ed. 2.1, 2013), IEC 60601-2-65 (Ed. 1.1, 2017) were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2.

Test reports were provided to demonstrate conformance. All test results complied with the requirements.

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

The EzRay Air 2 Wall (Model: VEX-S350W) 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:

The predicate device (EzRay Air Wall (Model: VEX-S300W) - K163705) is optimized for a digital sensor as an imaging receptor but EzRay Air 2 Wall (Model: VEX-S350W) can be used with a digital sensor or a phosphor plate as an imaging receptor according to the user's preference. For the user of a phosphor plate, EzRay Air 2 Wall (Model: VEX-S350W) provides increased tube voltage, tube current, and irradiation time compared to the predicate device. The tube voltage can be selected as either 65/70 kVp and the tube current is fixed at 5.0 mA The irradiation time has been increased up to 2.0 sec.

Based on the increased irradiation conditions, electrical safety and EMC test have been conducted. The performance of the EzRay Air 2 Wall (Model: VEX-S350W) was tested through Accuracy of loading factors, HVL, limitation of the x-ray field, reproducibility of Air KERMA, and Linearity of AIR KERMA. All test results are in compliance with Federal Standard (21CFR 1020.30 and 31) requirements.

A digital sensor and phosphor plate were used to verify the image performance for each image receptor. The image performance was evaluated with low contrast and line pair according to the IEC standard through performance bench testing.

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

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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 safety and performance 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 60601-2-65, 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, 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 2 Wall (Model: VEX-S350W) is substantially equivalent to the 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.