PORTABLE X-RAY SYSTEM by OSSTEM IMPLANT CO.,LTD

The Portable X-ray System(Model:EXARO) 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, 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, EXARO, 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 EXARO 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 EXARO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

AI/ML Overview

The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd. Portable X-Ray System (Model: EXARO). It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific information regarding acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment for a study proving the device meets acceptance criteria.

The document focuses on regulatory compliance, specifically demonstrating that the EXARO system is substantially equivalent to a legally marketed predicate device (GENORAY Co.,Ltd.'s Portable X-Ray System, Model: PORT X II). This type of submission relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.

The "Safety, EMC and Performance Data" section states:
"The compliance of EXARO 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 EXARO in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements."

And under "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."

To answer your request, based only on the provided text, I can state what is mentioned and what is explicitly not mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criteria are adherence to various international safety and performance standards (UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, EN/IEC 60601-1-2 for EMC).
Reported Device Performance: The document states, "All test results were complied with the requirements" for the EMC test and that "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." However, no specific numerical performance metrics are provided in a table format within this document.

2. Sample size used for the test set and the data provenance

The document mentions "bench and clinical evaluation" but does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.

4. Adjudication method for the test set

The document does not provide any information about an adjudication method for a test set.

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

The document describes a portable X-ray system, which is a hardware device for image acquisition, not an AI or software device for image interpretation. Therefore, no MRMC study with AI assistance would typically be applicable or described for this type of device.

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

As this is a hardware X-ray system, a standalone algorithm-only performance study is not applicable. The device's primary function is to generate X-ray images, not to interpret them autonomously.

7. The type of ground truth used

The document does not specify the type of ground truth used for any evaluations. Given it's an X-ray system, ground truth for imaging performance might involve phantom studies, expert review of images, or correlation with clinical outcomes, but these details are not provided.

8. The sample size for the training set

The document describes a hardware medical device and does not involve a "training set" in the context of machine learning algorithms.

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

As there is no mention of a training set, this information is not applicable and not provided.

In summary: The provided 510(k) summary focuses on demonstrating regulatory compliance and substantial equivalence to a predicate device through adherence to recognized safety and performance standards for an X-ray hardware system, rather than detailing a study with specific acceptance criteria and performance metrics for an AI-enabled diagnostic device. Therefore, much of the requested information, which is highly relevant for AI/software devices, is not present in this document.

Summary

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K22/24

MAY 1 6 2013

Image /page/0/Picture/1 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. There is a degree symbol after the word "OSSTEM".

OSSTEM Implant Co., Ltc

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

Tab E 510K Summary

510K Summary

Portable X-Ray System / Model : EXARO

Submitter and US Official Correspondent 1. OSSTEM Implant Co,.Ltd. Submitter : US Official Correspondent. : HIOSSEN Inc., Patrick Lim, QA/RA manager. Contact : Telephone No .: 888-678-0001 267-759-7004 Fax No .: dtlim@osstem.com Email:
Establishment Registration Number 2. No establishment registration number has been assigned yet,.
1. Device Information Proprietary/Trade Name: Common/Usual Name: Classification Name: Product Code: Device Class:

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

1. Equivalent Legally Marketed Device 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 21 FCR 872.1800

Description of the Device

The potable X-ray system, EXARO, 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 EXARO 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

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OSSTEM Implant Co., Ltd.

OSSTEM" 30 Iho, 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

current, X-ray tubehead, electrical protective devices, and other elements. The EXARO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

1. Indications for use
  The Portable X-ray System(Model:EXARO) 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
  The compliance of EXARO 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 EXARO in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements.

Safety and Effectiveness, comparison to Predicate 8. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

May 16. 2013

Public Health Service

OSSTEM Implant Co., Ltd. % Mr. Patrick Lim QA/RA Manager 85 Ben Fairless Drive FAIRLESS HILLS PA 19030

Re: K122124

Trade/Device Name: Portable X-Ray System (Model: PORT X II) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: December 26, 2012 Received: April 09. 2013

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 vour 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 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.

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Page 2 - Mr. Lim

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/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/ReportalProblem/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/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

Michael D. O'Hara for

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

Enclosure

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OSSTEM Implant Co., Ltd. OSSTEM #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

Tab D Indications for Use Statement

510(k) Number K 22/24

Device Name : Portable X-Ray System (Model:EXARO)

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

Prescription Use_ X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 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)

Richard D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health. 122124 510(k)

Page 1 of

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.