The Portable X-ray System (Model: HAND-RAY) 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

The Portable X-ray System (Model: HAND-RAY) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that Xray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor). The Portable X-ray System (Model: HAND-RAY) is a diagnostic x-ray system, which is intended to be used 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. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: HAND-RAY).provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.

AI/ML Overview

The document provided is a 510(k) Summary for a Portable X-Ray System (Model: HAND-RAY). It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them.

Therefore, many of the requested fields cannot be directly extracted from this document, as it outlines regulatory compliance and a comparison to predicate devices, not the results of a specific performance study against defined acceptance criteria for diagnostic accuracy of an AI device.

However, I can extract information related to the device's technical specifications and safety/performance standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not define specific "acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) that an AI/device would need to meet. Instead, it demonstrates compliance with regulatory standards and technical specifications by comparing them to predicate devices.

The "device performance" reported is primarily in terms of technical specifications, safety, and electromagnetic compatibility (EMC) compliance.

Acceptance Criteria (Compliance/Specification)	Reported Device Performance (HAND-RAY)
Safety, EMC and Performance Standards
UL/IEC 60601-1 (general medical electrical equipment)	Complied
IEC 60601-1-3 (radiation protection in diagnostic X-ray)	Complied
IEC 60601-2-7 (high-voltage generators of diagnostic X-ray)	Complied
IEC 60601-2-28 (X-ray source assemblies for medical diagnosis)	Complied
IEC 60601-2-32 (medical X-ray equipment with imaging intensifiers)	Complied
EN/IEC 60601-1-2 (EMC for medical electrical equipment)	All test results complied with requirements
Technical Specifications (compared to predicates)
Energy Source	Rechargeable 24V, DC Lithium polymer battery pack
Exposure Time	0.02~1.8 seconds, 0.01 sec. increments
Time Accuracy	±(10% +1ms)
mA	2mA fixed
kVp	60kV fixed
Wave Form	Constant Potential (DC)
Source to skin distance	20cm
Cone diameter	6cm

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

Not applicable. This document describes a traditional X-ray system, not an AI device. The "bench and clinical evaluation" mentioned is for the device's safety and effectiveness compared to predicates, not for the diagnostic performance on a specific dataset. There is no information about data provenance or sample size for a "test set" in the context of an AI algorithm.

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. As this is not an AI device, there's no mention of a ground truth established by experts for a test set.

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

Not applicable. No test set for diagnostic performance is described.

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. This is a standalone X-ray hardware device, not an AI algorithm.

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

Not applicable. No ground truth is established for diagnostic performance of an algorithm. The "ground truth" here would relate to the physical measurements and operational parameters of the X-ray system itself, verified against engineering standards.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. No training set is involved.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Digi-X, with the words "Digi-X" in large, bold, black letters. Below the logo, in smaller letters, is the text "Dental IT Ubiquitous System". The logo is simple and modern, with a focus on the company's name.

K.092772

Exhibit 5 510(k) Summary

Portable X-Ray System / Model: HAND-RAY

1.	Submitter and US Official Correspondent	'JAN - 6 2010
----	-----------------------------------------	---------------

Submitter:	Hanjin Digi-X Co., Ltd.
Address:	#1101, Acetechno 10th
	470-5, Gasan-dong, Geumcheon-gu
	Seoul, 153-789, Korea
Official Correspondent:	Shin Kuk Yoo, Consultant
Telephone No.:	714-313-7442
Fax No.:	801-303-7455
Email:	skyone@LSKBioPartners.com

1. Establishment Registration Number The firm will be registered and listed prior to distribution of medical device.

3. Device Information

Proprietary/Trade Name:	Portable X-Ray System (Model: HAND-RAY)
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

4. Equivalent Legally Marketed Device

Predicate #1
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 per regulation 21CFR 872 1800

Predicate #2

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Manufacturer: DIGIMED Co., Ltd. Device Name: Portable X-Ray System (Model: DIOX-602) K082167 (Decision Date - Sep. 26, 2008) 510(k) Number: Extraoral Source X-Ray System: EHD, Class II per regulation 21 Classification: CFR 872.1800

5. Description of the Device

The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that Xray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor).

The Portable X-ray System (Model: HAND-RAY) is a diagnostic x-ray system, which is intended to be used 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. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: HAND-RAY).provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.

Indications for use റ.

The portable X-ray system (Model: HAND-RAY) 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 HAND-RAY 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. EMC test was performed by SGS Testing Korea Co., Ltd. for HAND-RAY in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements.

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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 Equivalence Chart

Company name	Hanjin Digi-X Co.	GENORAY Co.	DIGIMED Corp.
Model	HAND-RAY	PORT-X II	DIOX-602
510(k) No	New	K063121	K082167
Energy Source	Rechargeable 24V, DCLithium polymer batterypack	Rechargeable 22.2V DCLithium polymerbattery pack	Rechargeable 24V, DCLithium polymer batterypack
Expose time	0.02~1.8 seconds,0.01 sec. increments	0.01~2.0 seconds0.01 increments	0.01-1.6 seconds, 0.01increments
Time accuracy	±(10% +1ms)	±(10% +1ms)	±(10% +1ms)
mA	2mA fixed	2mA fixed	2mA fixed
kVp	60kV fixed	60kV fixed	60kV fixed
Wave form	Constant Potential(DC)	Constant Potential(DC)	Constant Potential(DC)
Safety, EMC andperformance	IEC 60601-1IEC 60601-1-2IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32	IEC 60601-1IEC 60601-1-2IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-7,IEC 60601-2-28,IEC 60601-2-32
Source toskin distance	20cm	20 cm	20cm
Cone diameter	6cm	7 cm	6.5 cm
User Interface	Exposure time:up, downselection of parts of teeth,adult andchild, film andsensor with display	Exposure time:up, downSelection buttons of partsof teeth, adult and child,film and sensor withdisplay	Exposure time:up, downTwo buttons formodes andselection of parts of teeth,adult andchild, film andsensor with display
Exposure switch	Control panel andremote controller	Control panel andremote controller	Control panel andremote controller
Tube head mounting	Yes	Yes	Yes
Intended use	Intended to use by trained dentists and dental technicians as an extra-oral x-raysource for producing diagnostic x-ray images using intra-oral image receptors. Its useis intended for both adult and pediatric subjects.

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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 Hanjin Digi-X Co., Ltd., believes that the portable X-ray system (Model: HAND-RAY) is safe and effective and substantially equivalent to the predicate devices, PORT-X II and DIOX-602.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Hanjin Digi-X Co., Ltd. % Mr. Shin Kuk Yoo Consultant LSK BioPartners, Inc. 215 S. Street, Ste 100B SALT LAKE CITY UT 84111

JAN - 6 2010

Re: K092772

Trade/Device Name: Portable X-Ray System (Model: Hand-Ray) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: November 27, 2009 Received: December 2, 2009

Dear Mr. Shin Kuk 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. Iisting 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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Janine M. Morris

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

Enclosure

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Exhibit 4

Indications for Use

510(k) number (if known):

Device Name: Portable X-Ray System (Model: HAND-RAY) Indications for Use:

The Portable X-ray System (Model: HAND-RAY) 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 _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,

(Division Sign-On)
Division of Reproductive, Abdomina and Radiological Devices 510(k) Number

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.