The XR-01 Portable X-Ray System is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects.

Device Description

XR-01, a portable X-ray system is mainly designed for dental diagnosis via X-ray exposure with intraoral image receptors, supplied with 25.2 V DC rechargeable Li-ion polymer battery. The portable X-ray system consist of an x-ray generator with an x-ray tube, device controller, beam limiting device, AC-DC power supply, charging unit and optional back scatter shield.

AI/ML Overview

The provided text contains information about the XR-01 Portable X-ray System and its substantial equivalence to predicate devices, focusing on regulatory compliance, electrical safety, battery safety, and general performance. However, it does not include the detailed results of a study demonstrating the device meets specific acceptance criteria related to its image quality or diagnostic performance. The document primarily discusses its compliance with safety and performance standards for an x-ray system, rather than a clinical study evaluating its diagnostic accuracy.

Therefore, many of the requested sections about acceptance criteria, detailed study results, sample sizes, ground truth establishment, and MRMC studies cannot be extracted from the provided text.

Here's an attempt to answer the questions based on the available information:

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

The document mentions compliance with general safety and performance standards rather than specific diagnostic acceptance criteria. The "Performance Testing" section states: "Performance test validate that accuracy, reproducibility, deviation and linearity of technical factors such as tube voltage, tube current and exposure time is meet the criteria. Safety tests in terms of HVL, leakage, x-ray field size meet Federal standard requirements."

The "criteria" are referred to as "Federal standard requirements" and "safety and performance standards", but the specific numerical acceptance values for accuracy, reproducibility, deviation, linearity, HVL, leakage, and x-ray field size are not provided.

Acceptance Criteria Category	Reported Device Performance (as described)
Accuracy of technical factors (tube voltage, tube current, exposure time)	Meets criteria (specific values not provided)
Reproducibility of technical factors (tube voltage, tube current, exposure time)	Meets criteria (specific values not provided)
Deviation of technical factors (tube voltage, tube current, exposure time)	Meets criteria (specific values not provided)
Linearity of technical factors (tube voltage, tube current, exposure time)	Meets criteria (specific values not provided)
Half Value Layer (HVL)	Meets Federal standard requirements (specific value not provided)
X-ray Leakage	Meets Federal standard requirements (specific value not provided)
X-ray Field Size	Meets Federal standard requirements (specific value not provided)

2. Sample sized 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 in the document. The text describes general "Performance Testing" but does not detail the nature of the test set, its size, or provenance.

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 as there is no mention of a clinical study involving experts establishing ground truth for a diagnostic performance evaluation.

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

This information is not provided.

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 is not mentioned in the provided document. The device is a portable X-ray system, not an AI-powered diagnostic tool. The submission is for a traditional 510(k) for an extraoral X-ray source.

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

This is not applicable as the device is an X-ray system, not an algorithm, and the document focuses on its technical performance and safety for generating images.

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

This information is not provided. The "Performance Testing" section refers to technical measurements against defined standards for X-ray devices (e.g., accuracy of kVp, mA, exposure time, HVL, leakage) rather than a ground truth for diagnostic accuracy derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. There is no mention of a training set for an algorithm in this submission.

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

This information is not provided. There is no mention of a training set or ground truth establishment for a training set in this submission.

Summary

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March 16, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Rolence Enterprise, Inc. % Sterling Cheng General Manager 18-3 Lane 231 Pu Chung Rd., Chungli Taovuan, 32083 TAIWAN

Re: K172928

Trade/Device Name: XR-01 Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: February 22, 2018 Received: February 23, 2018

Dear Sterling Cheng:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172928

Device Name XR-01 Portable X-Ray System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

SEQUENCE OF INSTRUCTIONS

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Image /page/3/Picture/1 description: The image shows the logo for ROLENCE. The logo consists of two stylized "R" letters intertwined on the left. To the right of the logo is the company name in both Chinese and English. The English name "ROLENCE" is in larger, bold font, while the Chinese name is above it in a smaller font.

510(k) Summary

Date 510(k) Summary prepared	2018/2/1
Submitter Name	Rolence Enterprise Inc.Address: 18-3 Lane 231 Pu Chung Rd., Chungli, TaoyuanTaiwan
Contact Person	Jui-Ya LaiRegulatory Affairs Quality Assurance Associate Manager
Telephone	+886-3-4631999
FAX	+886-3-4631997
Device Information
Type of 510(k) Submission	Traditional
Trade or Proprietary Name	XR-01 Portable X-Ray System
Common or Usual Name	Portable X-ray System
Regulation Name	Extraoral source x-ray system
Regulation Number	872.1800
Product Code	EHD
Class of Device	Class II
Panel	Radiology

1. Comparison with predicate devices:

	SubjectDevice	PrimaryPredicateDevice	Reference Devices			Source to skin distance	200 mm	210 mm	100 mm	> 100 mm (fixed by cone)
Device Name	XR-01Portable X-RaySystem	Nomad ProIntraoral X-Ray system	Port-X II	DX-3000Portable X-RaySystem		X-ray field Size	60 mm round	60 mm round	70 mm round	50 mm round
Regulation Number	872.1800	872.1800	872.1800	872.1800		User Interface	Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size, image receptor type and tooth selection icon on control panel.	Up-down buttons for exposure time selection, with timer display. Additionally, several user-selectable preset times with patient size, image receptor type, and tooth selection icons on an LCD display.	Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size and tooth selection icons on an LCD display.	Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size and tooth selection icons on an LCD display.
Regulation Name	Extraoralsource x-raysystem	Extraoralsource x-raysystem	Extraoralsource x-raysystem	Extraoralsource x-raysystem		Backscatter radiation protection	Available as optional accessory	171.45 mm dia. Pb-filled acrylic plastic scatter shield	None	Available as optional accessory
Regulatory Class	II	II	II	II		Exposure Switch	Exposure button at front body	Trigger on Handset	Exposure button at x-ray control panel	Exposure button at front body
Primary Product Code	EHD	EHD	EHD	MUH		Tube head mounting	Handheld or on a tripod	Handheld	Handheld or on a tripod	Handheld
Applicant Name	RolenceEnterprise Inc.	Aribex Inc.	Genoray Co.,Ltd.	Dexcowin Co.,Ltd.	Electrical	Energy source	Rechargeable 25.2 V DC Lithium Polymer battery pack	Rechargeable 22.2 V DC Lithium Polymer battery pack	Rechargeable 22.2 V DC Lithium Polymer battery pack	Rechargeable 16.8 V DC Lithium Polymer battery pack
510(k) Number	-	K081664	K063121	K133007		Exposure time	0.01 – 2.00 seconds in 0.01 steps	0.02 - 1.00 seconds in 0.01 increments	0.01 - 2.0 seconds in 46 steps	0.05 - 1.35 seconds in 0.01 steps
INTENDED USE	All four systems are intended as extraoral X-ray sources to beused with intraoral image receptors for diagnostic imaging bydentist or dental technicians.					mA	2 mA fixed	2.5 mA fixed	2 mA fixed	2 mA
Mechanical Size (mm)	174 x 178 x257	266.7 x 133.35x 304.8	197 x 147 x145.5	139 x 163.5 x66.5		kVp	60 kVp fixed	60 kVp fixed	60 kVp fixed	60 kvp
	Waveform	Constant Potential (DC)	Constant Potential (DC)	Constant Potential (DC)	Constant Potential (DC)
	Duty Cycle	1:30	1:60	N/A	1:60
Applied Standards		IEC 60601-1	IEC/EN	UL/IEC	21 CFR

Rolence Enterprise Inc.

No. 18-3, Lane 231, Pu chung Rd., Chungli, Taoyuan, 32083 Taiwan

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Rolence Enterprise Inc.

No. 18-3, Lane 231, Pu chung Rd., Chungli, Taoyuan, 32083 Taiwan

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Image /page/5/Picture/0 description: The image contains a logo for a company called "ROLENCE". The logo consists of two stylized "R" letters, one in blue and one in white, placed next to each other. To the right of the "R" letters, the company name "ROLENCE" is written in blue, with some Chinese characters above it. The Chinese characters are likely the company name in Chinese.

EN 60601-1-2, 60601-1,IEC 60601-1-3,IEC 60601-2-65,IEC 6213321 CFR1020.30,21 CFR	IEC 60601-1-3, IEC 60601-2-7, 21 CFR1020.30,21 CFR1020.31	60601-1,EN 60601-1-2, IEC 60601-1-2 21 CFRIEC 60601-2- 7,21 CFR1020.30,21 CFR1020.31	1020.30,1020.31
1020.31

Device Description

Indication for Use

The XR-01 Portable X-Ray System is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects.

Performance Testing

Subject device XR-01 complies with safety and performance standards which are in accordance with 21 CFR 1020.30 and 31. Performance test validate that accuracy, reproducibility, deviation and linearity of technical factors such as tube voltage, tube current and exposure time is meet the criteria. Safety tests in terms of HVL, leakage, x-ray field size meet Federal standard requirements.

Standards and Guidance Documents

Electrical Safety and EMC Standards

IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 ●
EN 60601-1-2:2015
IEC 60601-1-3:2008 (Second Edition) + A1:2013 for use in conjunction with IEC 60601-1:2005 (Third Edition) + A1:2012
IEC 60601-1-6:2010 (Third Edition) + A1:2013
IEC 60601-2-65:2012 (First Edition) for use in conjunction with IEC 60601-1:2005 (Third edition)

Battery Safety Standards

IEC 62133:2012 (Second Edition)

Usability Standards

IEC 62366: 2007 (First Edition) + A1: 2014

Radiation Control

21 CFR 1020.30
21 CFR 1020.31

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Guidance

Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use
How to Prepare a Special 510(k)
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Pediatric Information for X-ray Imaging Device Premarket Notifications
Applying Human Factors and Usability Engineering to Medical Devices
. . . . Content of Premarket Submissions for Management of Cybersecurity in Medical
Devices
Refuse to Accept Policy for 510(k)s
eCopy Program for Medical Device Submissions

Conclusion

The subject device and predicate devices have same intended use and principle of operation. Also, both of them met Federal regulations 21 CFR Part 1020.30, 1020.31 and international medical device safety standard. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Rolence Enterprise Inc. concludes that the Portable X-Ray System (XR-01) is safe and effective and substantially equivalent to predicate devices as described herein.

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.