The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral 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: BIOX) 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 teeth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates teeth and jaw, and makes X-ray images on a receptor (chemical film or digital sensor). The Portable X-ray System (Model: BIOX) 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: BIOX) provides sharp and clear images and protects patients and dentists from leakage radiation by using a lead protective seal.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the Portable X-Ray System (Model: BIOX). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for detecting a particular condition).

Instead, the acceptance criteria and proof provided relate to the device's technical specifications, safety, and performance as an X-ray source, ensuring it is as safe and effective as the predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and compliance with various IEC standards. The "reported device performance" refers to the BIOX model's specifications.

Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (BIOX Model)
Intended Use Equivalence	Intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intraoral image receptors. For both adult and pediatric subjects.
Energy Source	Rechargeable 24V DC Lithium polymer battery pack Or DC 24V Power Supply
Source to Skin Distance	210 Cm
Cone Diameter	6 Cm
Exposure Time Range	0.01-1.6 seconds, 0.01 increments
Time Accuracy	±(10% + 1ms)
mA (Tube Current)	3mA fixed
kVp (Tube Voltage)	60kV fixed
Wave Form	Constant Potential (DC)
Safety, EMC, and Performance Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32
User Interface	Exposure time: up, down select buttons of parts of teeth, adult and child, film and sensor with display
Exposure Switch	Control panel and remote controller
Tube Head Mounting	Yes

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

The document does not describe a clinical study in the form of a diagnostic image interpretation trial with a "test set" of patient data. The "tests" mentioned are:

Bench testing
Clinical evaluation (not detailed, but likely referring to a general assessment of functionality and safety, not a diagnostic accuracy study).

Therefore, there is no sample size for a test set of patient cases or information about data provenance in the context of diagnostic performance. The testing was focused on engineering and performance parameters 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

Not applicable. As no diagnostic accuracy study with a "test set" and "ground truth" for patient conditions was described, no expert consensus was established for such a purpose.

4. Adjudication method for the test set

Not applicable. There was no diagnostic accuracy study described that would require an adjudication method for case interpretations.

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

No MRMC comparative effectiveness study was done. The device is an X-ray source, not an AI-powered image analysis tool. Its purpose is to produce images, not to interpret them or assist human readers with AI.

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

Not applicable. The device is an X-ray source, not an algorithm, and does not operate in a "standalone" or "human-in-the-loop" performance context related to AI.

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

The document does not describe the establishment of ground truth for diagnostic purposes. The "ground truth" in this context is the physical and electrical performance parameters of the X-ray machine itself, which are verified through various engineering tests and compliance with recognized standards.

8. The sample size for the training set

Not applicable. Since this is an X-ray imaging device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for this purpose.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as a combination of:

Bench Testing: This likely involved engineering tests to verify the device's electrical, mechanical, and radiation output specifications (e.g., kVp, mA, exposure time accuracy, radiation leakage).
Clinical Evaluation: While not detailed, this would typically involve assessing the device's functionality, ease of use, and ability to produce clinically usable images in a practical setting. This is distinct from a diagnostic accuracy study.
Compliance with Standards: The device was tested and found to comply with a series of international standards:
- UL/IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- IEC 60601-1-3 (Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment)
- IEC 60601-2-7 (Particular requirements for the safety of high voltage generators of diagnostic X-ray generators) - likely a typo in the original document, often 2-7 is related to X-ray tubes
- IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
- IEC 60601-2-32 (Particular requirements for the safety of associated equipment of X-ray equipment)
- EN/IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)

The conclusion states that "The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices." This implies that the BIOX device met the safety and performance benchmarks set by the predicate device and the relevant international standards.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo for DigiMed. The logo consists of two parts: a stylized graphic on the left and the text "DigiMed" on the right. The graphic is an oval shape with three vertical bars inside, and the text "DigiMed" is written in a bold, sans-serif font.

K 103600

APR - 8 2011

5 510(k) Summary

5.1 Company and Correspondent Making the Submission:

Date Prepared:	June 16, 2008
Name:	DIGIMED Corporation
Address:	#311, ACE HIGH-END TOWER 3, 371-50 Gasan-Dong,Gumcheon-Gu, Seoul, 153-787, Korea
Tel:	+82-2-2624-1551
Fax:	+82-2-2624-1553
E-mail:	kwon@digimed.co.kr
Contact:	Youngbae Kwon, Managing Director

5.2 US Agent for FDA Contact:

Name:	Kim Antol
Company:	Sigma Digital X-Ray
Address:	1607 Barclay Blvd., Buffalo Grove, IL 60089
Tel:	847-419-0669
Fax:	847-419-0675
Email:	KAntol@sigmadigitalxray.com

5.3 Device Information:

Proprietary-Trade Name:	Portable X-Ray System (Models: BIOX)
Classification Name:	Extraoral Source X-Ray System: EHD, Class II perregulation 21CFR 872.1800
Common/Usual Name:	Portable X-Ray System

5.4 Predicate Devices :

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

5.5 Indications for Use (Intended Use):

p. 1 of 3

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

5.6 Description of Device

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

The Portable X-ray System (Model: BIOX) 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: BIOX) provides sharp and clear images and protects patients and dentists from leakage radiation by using a lead protective seal.

5.7 Safety and Effectiveness, Comparison to Predicate Device:

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

5.8 Safety, EMC and Performance Data:

The portable X-ray system, BIOX, will comply with 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 testing was conducted by EMC Compliance Co., Ltd. and SGS Testing Korea Co., Ltd. for BIOX in accordance with Standard EN/IEC 60601-1-2. All test results were satisfactory.

5.9 Substantial Equivalence Chart

$$\mathfrak{g}\cdot\mathfrak{a}\bullet\mathfrak{b}$$

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

Company name	GENORAY Co.	DIGIMED Corp.
Model	PORT-X II	BIOX
Intended use	Intended to use by trained dentists and dental technicians as an extra-oralx-ray source for producing diagnostic x-ray images using intra-oralimage receptors or film. It is intended to use for both adult and pediatricsubjects.
510k No	K063121	New
Energy Source	Rechargeable 22.2VDC Lithium polymer battery pack	Rechargeable 24V,DC Lithium polymer battery packOr DC 24V Power Supply
Source toskin distance	20 Cm	210Cm
Cone diameter	7 Cm	6Cm
Expose time	0.01~2.0 seconds0.01 increments	0.01-1.6 seconds,0.01 increments
Time accuracy	±(10% +1ms)	±(10% +1ms)
mA	2mA fixed	3mA fixed
kVp	60kV fixed	60kV fixed
Wave form	Constant Potential(DC)	Constant Potential(DC)
Safety, EMC andperformance	IEC 60601-1,IEC 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
User Interface	Exposure time: up, down selectbuttons of parts of teeth, adult andchild, film and sensor with display	Exposure time: up, down selectbuttons of parts of teeth, adult andchild, film and sensor with display
Exposure switch	Control panel and remote controller	Control panel and remote controller
Tube headmounting	Yes	Yes

5.10 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided the above comparison table, the DIGIMED Corpor -ation concludes that the portable X-ray System (Model: DIOX-602, PROX) is safe and effective and substantially equivalent to the predicate device as described above.

p. 3 of 3

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

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal 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

Digimed Corporation % Mr. Kim Antol President Sigma Digital X-Ray 1607 N. Barclay Ave. BUFFALO IL 60089

APR - 8 201

Re: K103600

Trade/Device Name: Portable x-ray system (Models: BIOX) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: March 10, 2011 Received: March 10, 2010

Dear Mr. Antol:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally manketed predicate device results in a classification for your device and thus, permits your dry many proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety of (01) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

K103600 510(k) Number (if known):

Device Name: Portable x-ray system (Models: BIOX)

Indications for Use:

The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral 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 __ AND/OR

(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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Patel

Office of In

510K K103600

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.