The Portable X-ray System (Model: DXR-1) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Device Description

DXR-1, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, DXR-1, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of DXR-1 starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor) This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The DXR-1 produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EXARO Co., Ltd. Portable X-Ray System (Model: DXR-1):

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA. This type of document primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a publication for a novel device would. Therefore, much of the requested information (like specific sample sizes for test sets, number of experts for ground truth, or details of multi-reader studies) is not present in this document. The "study" mentioned is primarily a bench and clinical evaluation comparing the new device to a predicate device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DXR-1 are generally implied by its demonstrated "substantial equivalence" to the predicate device, the GENORAY Co., Ltd. PORT-X II. The study aims to show that the DXR-1 is as safe and effective as the predicate. The table below outlines the key technical specifications and safety/performance standards, indicating where the DXR-1 either matches or falls within acceptable comparative ranges of the predicate.

Acceptance Criteria (Implied by Predicate)	DXR-1 Reported Device Performance	Notes
Rechargeable Power Source: 22.2V DC Lithium Polymer battery pack	Rechargeable 25.2V DC Lithium Polymer Battery pack	Similar technology, slightly higher voltage in DXR-1.
Exposure Time: 0.01-2.0 seconds, 0.01 increments	0.01-1.6 seconds, 0.01 increments	Similar range, DXR-1 has a slightly shorter maximum exposure time.
Time Accuracy: ±(10%+1ms)	±(10%+1ms)	Matches predicate.
Heat Capacity: 8.5 KHU	8.5 KHU	Matches predicate.
Power Output: 100 W	180 W	DXR-1 has higher power output. This would typically be seen as an improvement, provided it doesn't negatively impact safety or image quality and remains within accepted radiation dose limits for its intended use.
mA: 2mA fixed	2mA fixed	Matches predicate.
kVp: 60kV fixed	60kV fixed	Matches predicate.
Focal Spot: 0.8 mm	0.8 mm	Matches predicate.
Wave Form: Constant Potential (DC)	Constant Potential (DC)	Matches predicate.
Safety, EMC, Performance Standards (IEC 60601-1series)	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32	DXR-1 is stated to comply with the same standards as the predicate.
Source to skin distance: 20cm	20cm	Matches predicate.
Cone Diameter: 7cm	6 cm	DXR-1 has a slightly smaller cone diameter. This may influence beam coverage but typically would be assessed for its impact on image capture and radiation protection.
User Interface: Exposure time controls, tooth/adult/child/film/sensor selection	Exposure time controls, tooth/adult/child/film/sensor selection	Matches predicate functionally.
Exposure switch: Control panel and remote controller	Control panel and remote controller	Matches predicate.
Tubehead mounting: Yes	Yes	Matches predicate.
Intended Use: Extra-oral X-ray source for diagnostic images using intraoral receptors for adult and pediatric subjects.	Intended to use by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects.	Matches predicate.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" sample size for a clinical study in the typical sense (e.g., number of patients or images). The "bench and clinical evaluation" is mentioned, implying some form of testing, but detailed clinical reader study parameters are not disclosed.
- Data Provenance: Not specified in the provided text. It's common for submission data to be from the manufacturer's home country (Korea in this case) or internal studies, but this is not explicitly stated for the clinical evaluation. The document is for a 510(k) submission, not a scientific publication, so such detail is often omitted if not directly required for substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a 510(k) of this nature, clinical "ground truth" might be implied by comparison to the predicate device's established performance, or by standard clinical diagnostic practices, rather than a formal expert consensus study for the specific device under review.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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, this was not a MRMC study. The device described is a portable X-ray system, not an AI-powered diagnostic tool. The document details the hardware (X-ray generator, tubehead, controls) and its performance characteristics, not an algorithm's diagnostic capabilities or reader improvement with AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable. The DXR-1 is an X-ray imaging device itself, not an algorithm that performs a standalone diagnosis. Its performance would be evaluated based on image quality, radiation output, safety, and functionality, not a diagnostic algorithm's accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document implies that the ground truth for the "clinical evaluation" would be standard diagnostic X-ray image quality criteria, potentially judged by dental professionals, against images produced by the predicate device or against clinically acceptable diagnostic images. However, the specific method (e.g., "expert consensus" or direct comparison to "pathology") is not specified. For an X-ray device, image quality and the ability to produce diagnostic images sufficient for clinical decision-making are the primary "ground truth" goals.
The sample size for the training set:
- Not applicable / not provided. This device is a hardware system, not a machine learning model, so there is no "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI training set for this hardware device.

Summary

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FEB - 5 2009

Exhibit 5 510(k) Summary

Portable X-Ray System / Model: DXR-1

గా

Submitter and US Official Correspondent

Submitter:	EXARO Co., Ltd.
Address:	#1201 World Meridian Venture Center I
	426-5 Gasan-Dong, Gumcheon-Gu
	Seoul, 153-803, Korea
Official Correspondent:	Shin Kuk Yoo, BD Manager
Telephone No.:	801-303-7440 (Ext. 202)
Fax No.:	801-303-7455
Email:	skyone@LSKBioPartners.com

Establishment Registration Number The firm will be registered and listed prior to 2. distribution of medical device.
Device Information Proprietary/Trade Name: Portable X-Ray System (Model: DXR - 1) Common/Usual 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
Equivalent Legally Marketed Device 4.

Manufacturer:	GENORAY Co., Ltd.
Device Name:	Portable X-Ray System (Model: PORT-X II)
510(k) Number:	K063121 (Decision Date - Jan. 11, 2007)
Classification:	Extraoral Source X-Ray System: EHD, Class II perregulation 21 CFR 872.1800

Description of the Device ട്.

DXR-1, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, controls and power source

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are assembled into a single hand-held enclosure. The package includes a battery charger.

The potable X-ray system, DXR-1, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of DXR-1 starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)

This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The DXR-1 produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

Indications for use 6.

The portable X-ray system (Model: DXR - 1) is intended to be used by trained dentists and dental technicians as extraoral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Safety, EMC and Performance Data 7.

The compliance of DXR-1 will satisfy the applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements.

EMS test was performed by SGS Testing Korea Co., Ltd. for DXR-1 in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements.

8. Safety and Effectiveness, comparison to Predicate

The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.

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Substantial Eguivalence Chart တံ

. . . . . .

Company	GENORAY Co. Ltd.	EXARO Co., Ltd.
Model	PORT-X II	DXR-1
510(k) No	K063121	Not assigned yet
Energy	Rechargeable 22.2V, DC Lithium	Rechargeable 25.2V, DC
Source	Polymer battery pack	Lithium Polymer Battery pack
Expose Time	0.01-2.0 seconds, 0.01 increments	0.01-1.6 seconds, 0.01 increments
Time Accuracy	±(10%+1ms)	±(10%+1ms)
Heat Capacity	8.5 KHU	8.5 KHU
Power Output	100 W	180 W
mA	2mA fixed	2mA fixed
kVp	60kV fixed	60kV fixed
Focal Spot	0.8 mm	0.8 mm
Wave Form	Constant Potential (DC)	Constant Potential (DC)
Safety, EMC andperformance	IEC 60601-1, IEC 60601-1-2, IEC60601-2-7, IEC 60601-2-28, IEC60601-2-32	IEC 60601-1, IEC 60601-1-2, IEC60601-2-7, IEC 60601-2-28, IEC60601-2-32
	Source to skindistance	20cm	20cm
	Cone Diameter	7cm	6 cm
User Interface	Exposure time: up, down.Selection buttons of parts of teeth,adult and child, film and sensorwith display.	Exposure time: up, down.Selection buttons of parts of teeth,adult and child, film and sensorwith display.
Exposure switch	Control panel and remote controller	Control panel and remotecontroller
TubeheadMounting	Yes	Yes
Intended Use	Intended to use by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intra-oralimage receptors or film. It is intended to use for both adult and pediatricsubjects.

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: 六六十四十四

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10. · Conclusion

. . .

In reference to the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807 and the comparison information provided substantial equivalent chart above, the EXARO Co., Ltd., believes that the portable X-ray system (Model: DXR-1) is safe and effective and substantially equivalent to the predicate device (Model: PORT-X II).

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con

. .

、

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2009

EXARO Co., Ltd. % Mr. Shin Kuk Yoo LSK BioPartners, Inc. 215 South State Street, Suite 100B SALT LAKE CITY UT 84111

Re: K082875

Trade/Device Name: Portable X-Ray System (Model: DXR-1) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD and MUH Dated: January 29, 2009

Received: February 2, 2009

Dear Mr. Yoo:

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Exhibit 4 Indications for Use

lications for use

510(k) number (if known): _KO82 875

Device Name: Portable X-Ray System (Model: DXR-1) Indications for Use:

The Portable X-ray System (Model: DXR-1) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use

(Part 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)

Helen Lewin

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 0810875 510(k) Number

15/336

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.