The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

Device Description

EXARO, Xray2GO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, Xray2GO, 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 operating principle of EXARO, Xray2GO 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 tube head, electrical protective devices, and other elements. The EXARO, Xray2GO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Portable X-ray System (Model: EXARO, Xray2GO). This notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Portable X-Ray System, Model: EXARO, K122124).

The document does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.

Instead, the submission relies on demonstrating substantial equivalence through a comparison of technical specifications and adherence to safety and performance standards.

Here's a breakdown of the information that can be extracted based on your request, and what is missing:

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

This information is not explicitly present in the document in the form of diagnostic accuracy or clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) and reported device performance against those criteria. The acceptance criteria for the submission appear to be centered around meeting established electrical and radiation safety standards, along with demonstrating comparable technical specifications to a predicate device.

The table provided in the document (pages 4-5) lists technical characteristics of the proposed device and compares them to the predicate device. This is used to demonstrate substantial equivalence, not to report on diagnostic performance against pre-defined clinical acceptance metrics.

Characteristic	Proposed OSSTEM Implant Co,. Ltd. EXARO, Xray2GO	Predicate OSSTEM Implant Co., Ltd. EXARO
Anode current	3mA	2mA
Expose time	0.01~1.6 seconds, 0.01 increments	0.01~2.0 seconds, 0.01 increments
Battery part No.	SPB605060H4	JBL7451251700100FJ
Battery Current	12.0CmA	1.0CmA
Battery Max. Current	1900mAh	950mAh
Battery case size	87 x 111.9 x 42H (mm)	87 x 111.9 x 36H (mm)
Time Accuracy	±(10%+1ms)	±(10%+1ms)
Heat Capacity	8.5 KHU	8.5 KHU
Power Output	100W	100W
mA	3mA Fixed	2mA Fixed
kVp	60kV Fixed	60kV Fixed
Focal Spot	0.8mm	0.8mm
Wave Form	Constant Potential (DC)	Constant Potential (DC)
Safety, EMC and Performance	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32
Source to skin Distance	20cm	20cm
Cone Diameter	6cm	6cm

The "acceptance criteria" here implicitly are that the proposed device's characteristics are comparable to the predicate such that it does not raise new questions of safety or effectiveness, and that it meets the listed IEC standards.

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

This information is not provided. The submission states: "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." (page 5). However, no details about the "clinical evaluation" such as sample size, type of data (retrospective/prospective), or country of origin are given. This suggests the clinical evaluation performed was likely not a formal diagnostic performance study with a test set in the way you're asking.

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)

This information is not provided. Since no detailed clinical performance study with a test set validation is described, there's no mention of experts establishing ground truth.

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

This information is not provided for the same reasons as point 3.

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

An MRMC study was not conducted or described. This device is an X-ray system, not an AI-powered diagnostic tool. The document focuses on the hardware's safety and performance characteristics and its substantial equivalence to a predicate X-ray system. Improvement with AI assistance is not relevant to this device's submission.

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

A standalone algorithm performance study was not applicable and not done. This is a hardware device for generating X-rays, not a standalone algorithm.

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

This information is not provided as no detailed clinical performance study with a test set is described. For a device like an X-ray generator, the "ground truth" for its output is typically assessed through physical measurements (e.g., radiation output, image quality parameters using phantoms) rather than clinical diagnostic ground truth.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary of what the document indicates for "acceptance criteria" for this type of device:

For this 510(k) submission, the "acceptance criteria" are implicitly met by:

Demonstrating the device is substantially equivalent to a predicate device (K122124) in terms of intended use, technology, design, functions, and principle of operation.
Showing that any differences (e.g., anode current, expose time, battery specifications) do not raise new questions of safety and effectiveness.
Conforming to recognized safety, EMC (Electromagnetic Compatibility), and performance standards, specifically:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)
- IEC 60601-2-7 (Medical electrical equipment - Part 2-7: Particular requirements for the safety of medical photographic X-ray equipment)
- IEC 60601-2-28 (Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
- IEC 60601-2-32 (Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment for X-ray equipment)

The study proving the device meets these acceptance criteria is the technical comparison to the predicate device and the implied testing to relevant IEC standards. The document explicitly states: "No additional testing was added for this submission based on the modifications" (page 5), and "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices" (page 5). However, no details of these specific tests or evaluations are provided beyond the table of characteristic comparisons.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

August 26, 2014

Osstem Implant Co. Ltd. % Patrick Lim OA/RA Manager, Hiossen Inc. 85 Ben Fairless Drive FAIRLESS HILLS, PA 19030

Re: K141497

Trade/Device Name: Portable X-Ray System (Model: EXARO, Xray2GO) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: II Product Code: EHD Dated: July 25, 2014 Received: July 28, 2014

Dear Mr. Lim:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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.

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/ResourcesforYou/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,

Smh.f)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K141497/S001

Device Name: Portable X-ray System (Model: EXARO, Xray2GO)

Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k): K141497/S001

Page 1 of __

{3}------------------------------------------------

OSSTEM Implant Co., Ltd.

301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com

510K Summary

Portable X-Ray System / Model : EXARO, Xray2GO

1.	Company and Correspondent Making the Submission
	Submitter :	OSSTEM Implant Co,.Ltd.
	Address :	301ho, Korea Electronics Cooperation B/D 114Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea153-803
	Tel :	82-70-4394-5029
	Fax :	82-2-863-3479
	E-mail :	qa@osstem.com
	Contact :	Mr. Mooyong Park

1. US Agent for FDA Contact : Name : HIOSSEN Inc., Address : 85 Ben Fairless Dr. Fairless Hills, PA 19030 USA Contact : Patrick Lim, QA/RA manager. Telephone No.: 888-678-0001 Fax No.: 267-759-7004 Email: dtlim@osstem.com
- 1. Device Information Proprietary/Trade Name: Common/Usual Name: Classification Name: Product Code: Device Class:

Portable X-Ray System (Model: EXARO, Xray2GO) Portable X-Ray System Extraoral Source X-Ray System EHD Class II per regulation 21 CFR 872.1800

1. Equivalent Legally Marketed Device K number: K122124 Proprietary/Trade Name: Portable X-Ray System(Model:EXARO) Common/Usual Name: Portable X-Ray System Classification Name: Extraoral Source X-Ray System Product Code: EHD Class II per regulation 21 CFR 872.1800 Device Class:
న. Date Prepared: 6/4/2014

{4}------------------------------------------------

OSSTEM Implant Co., Ltd.

301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com

6. Description of the Device

Characteristic	ProposedOSSTEM Implant Co,. Ltd.EXARO, Xray2GO	PredicateOSSTEM Implant Co., Ltd.EXARO
510(k) number	Not assigned yet	K122124
Anode current	3mA	2mA
Expose time	0.01~1.6 seconds, 0.01 increments	0.01~2.0 seconds, 0.01 increments
Battery	Battery part No.	SPB605060H4	JBL7451251700100FJ
	Battery Current	Current : 12.0CmA	Current : 1.0CmA
	Battery Max. Current	Max. current : 1900mAh	Max. current : 950mAh
Battery case size	87 x 111.9 x 42H (mm)	87 x 111.9 x 36H (mm)
	NEW	Predicate Device
Manufacturer	OSSTEM IMPLANT Co., Ltd.	OSSTEM IMPLANT Co., Ltd.
Model	EXARO, Xray2GO	EXARO
510(k)Number	Not assigned yet	K122124
EnergySource	Rechargeable 25.2V, DC LithiumPolymer Battery pack	Rechargeable 25.2V, DC LithiumPolymer Battery pack
Expose Time	0.01~1.6 seconds, 0.01 increments	0.01~2.0 seconds, 0.01 increments
Time Accuracy	±(10%+1ms)	±(10%+1ms)
Heat Capacity	8.5 KHU	8.5 KHU
Power Output	100W	100W
mA	3mA Fixed	2mA Fixed
kVp	60kV Fixed	60kV Fixed
Focal Spot	0.8mm	0.8mm
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	6cm	6cm
User Interface	Exposure time: up, down.Selection buttons of parts of teeth,adult and child, film and sensor withdisplay.	Exposure time: up, down.Selection buttons of parts of teeth,adult and child, film and sensor withdisplay.
Exposure switch	Control panel and remote controller	Control panel and remote controller
TubeheadMounting	Yes	Yes
Principle ofOperation	X-ray generated by high voltageelectricity into X-ray tube, whichpenetrates hand, tooth and jaw, andmakes X-ray images on receptor(Chemical Film or Digital Sensor)	X-ray generated by high voltageelectricity into X-ray tube, whichpenetrates hand, tooth and jaw, andmakes X-ray images on receptor(Chemical Film or Digital Sensor)
Intended Use intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral imagereceptors or film. Its use is intended for both adult and pediatric subjects.

A list of modifications made to the subject device is below:

1. Indications for use (Intended Use) The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
1. Safety, EMC and Performance Data No additional testing was added for this submission based on the modifications.
1. 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.

{5}------------------------------------------------

TEM®

OSSTEM Implant Co., Ltd.

301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com

10. Substantial Equivalence Chart

{6}------------------------------------------------

OSSTEM Implant Co., Ltd.

301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com

The subject and predicate devices are similar in indications, design, technology, functions, and principle of operation.

The differences between two devices are anode current, expose time, battery (part no., current, and maximum current) and battery case size.

Any differences do not raise different questions of safety and effectiveness than the predicate. Therefore, there is no difference between the subject and predicate with respect to the indications or technology.

1. 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 OSSTEM IMPLANT Co., Ltd., believes that the portable X-ray system (Model: EXARO, Xray2GO) is substantially equivalent to its 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.