PORT-X IV is a portable X-ray system to be used by trained dental technicians as a mobile, extra oral x-ray source for producing diagnostic x-ray images using intra oral image receptors. It is intended for both adult and pediativ subjects.

Device Description

The portable X-Ray system, PORT-X IV, is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is the X-ray equipment and uses it to diagnose the patient to acquire images. It also includes accessories, which are battery, recharging unit and hand switch.

AI/ML Overview

The provided text is a 510(k) summary for the GENORAY Co., Ltd. PORT-X IV, a portable X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device (Metabiomed, Inc. REXTAR X) rather than presenting a study to prove the device meets specific acceptance criteria for AI/algorithm performance. Therefore, many of the requested elements for an AI-based device's acceptance criteria and study are not applicable or cannot be extracted from this document.

However, I will extract what is available regarding general device performance and safety.

Here's the breakdown of the information based on the prompt and the provided text:

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

The document does not explicitly state "acceptance criteria" in a table format for AI performance. Instead, it details performance standards and safety criteria for an X-ray device based on federal and international standards.

Acceptance Criteria (Standards and Requirements)	Reported Device Performance (PORT-X IV)
Safety and General Performance Standards
IEC 60601-1 Series (Electrical, mechanical, environmental safety and performance)	Complies with IEC 60601-1 Series. Electrical, mechanical, and environmental safety and performance testing performed. All test results were satisfactory.
IEC 60601-1-3 (Radiological protection)	Complies with IEC 60601-1-3. Radiological protection testing performed. All test results were satisfactory.
IEC 60601-2-65 (Specific requirements for dental X-ray equipment)	Complies with IEC 60601-2-65. Testing performed. All test results were satisfactory.
IEC 60601-1-2 (EMC testing)	EMC testing conducted in accordance with IEC 60601-1-2. All test results were satisfactory.
Radiation Control Provisions (21 CFR 1020.30 & 1020.31)
Focal spot to skin distance: Longer than minimum length of 18 cm	Confirmed that the focal spot to skin distance was longer than the minimum length of 18 cm.
Minimum HVL (half-value layer): 1.5 mm	Confirmed that the minimum HVL was 1.5 mm.
Accuracy of loading factors (e.g., <70kVp +10%)	Accuracy of loading factors met essential performance requirements in accordance with IEC 60601-1 (e.g., <70kVp +10%).
Reproducibility of AIR KERMA	Reproducibility of AIR KERMA met essential performance requirements in accordance with IEC 60601-1.
Software Validation	Software Validation performed. All test results were satisfactory. (No specific metrics or acceptance criteria for software itself mentioned, beyond satisfactory outcome).
Clinical Evaluation	Clinical Evaluation performed. All test results were satisfactory. (No specific metrics or acceptance criteria for clinical efficacy beyond satisfactory outcome and substantial equivalence to predicate).
Overall Comparison	The performance test confirms that the device is as safe and effective as the predicate device (REXTAR X K132041). "EMC and performance data demonstrated that the PORT-X IV is as safe and effective as the predicate device." "All the test results were satisfied and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device." "PORT-X IV is safe and effective as predicate device, and has no new indication for use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "bench and clinical evaluation" and "performance testing" but does not specify a "test set" in terms of patient data or image datasets with a sample size for evaluating an algorithm. The testing described is related to the physical performance, safety, and electrical characteristics of the X-ray device itself.

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 is an X-ray generator, not an AI-powered diagnostic tool. Ground truth establishment by experts for image interpretation is not mentioned as part of its regulatory submission.

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

Not applicable.

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 is not an AI-assisted device.

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

Not applicable.

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

Not applicable. The "ground truth" here is compliance with established electrical, radiation, and safety standards for X-ray equipment.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI algorithm.

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

Not applicable.

Summary

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GENORAY Co., Ltd. % Mr. Chris Yoon Business Development Manager Genoray America Inc. 147 E. Bristol Lane ORANGE CA 92865

March 7, 2018

Re: K172810

Trade/Device Name: PORT-X IV Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: January 9, 2018 Received: February 12, 2018

Dear Mr. Yoon:

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.

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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.

Robert Sauer

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) K172810

Device Name PORT-X IV

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)

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Exhibit 5 510(k) Summary

Date of Summary Preparation: Aug. 11, 2017

1. Submitter and US Official Correspondent
Submitter :	GENORAY Co., Ltd.
Address:	512, 560, Dunchon-daero, Jungwon-gu,Seongnam-si, Gyeonggi-do,13230, KOREA
Telephone No.:	+82-31-740-4100
Fax:	+82-31-737-8018
Official Correspondent (U.S): Kaitlynn Min - Business Manager

Correspondent:	GENORAY America Inc.
Address:	147 E. Bristol Lane, Orange, CA 92865 USA
Telephone No.:	+1-855-436-6729
Fax:	+1-714-786-8919
Email:	kaitlynn @ genorayamerica.com

2. Establishment Registration Number 3005843418

3. Device Information

Trade/Device Name:	PORT-X IV
Regulation Name:	Portable X-ray System
Classification Name:	Extraoral Source X-ray System
Product Code:	EHD
Device Class:	Class II per regulation 21 CFR 872.1800

1. Predicate Device(Equivalent Legally Marketed Device)

Manufacturer:	Metabiomed, Inc.
Device Name:	REXTAR X
510(k) Number:	K132041 (Decision Date – Jul 31, 2013)
Classification:	Extraoral Source X-ray SystemClass II per regulation 21 CFR 872.1800

1. Description of the Device
  The portable X-Ray system, PORT-X IV, is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is the X-ray equipment and uses it to diagnose the patient to

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acquire images. It also includes accessories, which are battery, recharging unit and hand switch.

6. Indications for use (intended use)

PORT-X IV is a Portable X-Ray System to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

	Proposed device	Predicate device
Name	PORT-X IV	REXTAR X
Manufacturer	GENORAY Co., Ltd.	Metabiomed, Inc.
510(k) No.	-	K132041
Indicationsfor use	PORT-X IV is a portable X-raysystem to be used by trained dentistsand dental technicians as a mobile,extraoral x-ray source for producingdiagnostic x-ray images usingintraoral image receptors. It isintended for both adult and pediatricsubjects.	REXTAR X is a portable X-raysystem to be used by trained dentistsand dental technicians as a mobile,extraoral x-ray source for producingdiagnostic x-ray Images usingIntraoral Image receptors. It isintended for both adult and pediatricsubjects.
X-rayGenerator	Tube Voltage : 70 kVTube Current : 2 mA	Tube Voltage : 70 kVTube Current : 2 mA
X-ray Controller	Exposure Time : 0.05~1.6 sec	Exposure Time : 0.01~1.30 sec
X-ray Tube	Stationary Anode	Stationary Anode
	Focus : 0.4 mm	Focus : 0.4 mm
	Target Angle : 12.5°Total Filtration : 2.2 mmAl(Inherent Filtration : 1.0 mmAl;Additional Filtration : 1.2 mmAl)	Target Angle : 12°Total Filtration : 1.5 mmAl(Inherent Filtration : 1.0 mmAl;Additional Filtration : 0.5 mmAl)

Battery	Type : Rechargeable	Type : Rechargeable
Display	LCD panel Display	LCD panel Display
Dimensions andWeight	Dimension(mm):140 x 173 x 254Weight(kg): 1.6 kg	Dimension(mm): 146 x 155 x 139Weight(kg): 2 kg

1. Substantial equivalence chart

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The technical characteristics of the PORT-X IV and predicate device are similar. However the range of the exposure time and the total filtration of X-rav tube are little different. Those differences does not affect the performance and safety. EMC and performance data demonstrated that the PORT-X IV is as safe and effective as the predicate device.

The PORT-X IV is substantially equivalent to the predicate device, REXTAR X(K132041).

8. Safety, EMC and Performance data comparison to Predicate device

Safety, EMC and Performance Data

PORT-X IV complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30 and 21CFR 1020.31 to minimize electrical, mechanical and radiation hazards.

· Electrical, mechanical, environmental safety and performance testing which are mentioned in the standard IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-65 were performed.
· EMC testing was conducted in accordance with standard IEC 60601-1-2.
· Performance testing performed according to FDA 21 CFR 1020.30, 21 CFR 1020.31 standards, Software Validation, Clinical Evaluation. All test results were satisfactory.
Summary of Performance Testing

The performance test for the subject device, PORT-X IV and the predicate device, REXTAR X(K132041) confirmed that the focal spot to skin distance of both devices were longer than the minimum length of 18 cm in accordance with Federal Standard (21CFR 1020.30 and 31) requirements. Also minimum HVL (half-value layer) of both devices were 1.5 mm in accordance with Federal Standard (21CFR 1020.30 and 31) requirements. Accuracy of loading factors and reproducibility of AIR KERMA for both devcies also met the essential performance requirements in accordance with IEC 60601-1 (ex. <70kVp +10%).

All the test results were satisfied and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device.

9. FDA Guidance Documents Utilized

Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use, issued December 24,2008
Guidance for the Content of Premakret Submissions for Software Contained in Medical Devices, issued Nov 28, 2017
Pediatric Information for X-ray Imaging Device Premarket Notifications, issued May 10, 2012
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014

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General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued Jun 9, 1997.
Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, Aug 6, 1999.

10. Conclusion

In reference to the comparison information provided in substantial equivalence chart, most of functions and electronic features are similar with predicate device. We believe that the PORT-X IV is safe and effective as predicate device, and has no new indication for use. Therefore, PORT-X IV is substantially equivalent to predicate device.

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.