The HyperLight Portable X-ray Unit 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 receptors. Its use is intended for both adults and pediatric subjects.

Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

Device Description

HyperLight Portable X-ray Unit of Changzhou Sifary Medical Technology Co., Ltd., is a handheld x-ray device. The technology of portable x-ray devices was originally developed in the 1950s and was originally designed to be used in situations where there was no access to fixed x-ray units. With new technological possiblities arising, the use of portable handheld devices are becoming more mainstream.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The intraoral x-ray detectors are not part of the subject device. The functions of the HyperLight Portable device are supported by software. The software package is of Moderate level of concern and it's not based on the predicate system.

This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The handheld x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (HyperLight Portable X-ray Unit). It does not contain information about an AI/ML algorithm or a study related to its performance against acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (MobileX Portable X-ray System) based on technical characteristics, indications for use, and non-clinical performance data (electrical safety, EMC, software validation, biocompatibility, usability, risk assessment, and clinical comparison).

Therefore, I cannot provide the requested information about acceptance criteria, study details for an AI/ML algorithm, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The document discusses the following:

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

The document provides a "Comparison of Technological Characteristics with Predicate" table, which acts as a comparison against a predicate device, not against specific quantitative acceptance criteria for an AI/ML algorithm.
It lists characteristics like size, source to skin distance, cone diameter, user interface, backscatter radiation protection, exposure switch, electrical information (exposure time, time accuracy, mA, kVp, waveform, total filtration), and performance standards.
For example, for "Exposure time," the subject device's reported performance is "0.02 ~ 2.0 seconds in .01-.40s increments (20 steps)" compared to the predicate's "0.01 ~ 1.3 seconds in 0.01 or 0.05 increments." This is a comparison, not an acceptance criterion with a pass/fail threshold.

2. Sample sized used for the test set and the data provenance:

Not applicable. The document describes non-clinical performance data, primarily engineering and safety tests, and a comparison to a predicate device. There is no mention of a test set with patient data for an AI/ML algorithm, nor data provenance (country of origin, retrospective/prospective).

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

Not applicable. No AI/ML algorithm performance study is described that would require expert-established ground truth.

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

Not applicable. No AI/ML algorithm performance study 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. No MRMC study or AI assistance for human readers is mentioned.

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

Not applicable. No AI algorithm is the focus of this 510(k) submission. The device is a portable X-ray unit.

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

Not applicable. There is no AI/ML algorithm requiring ground truth from clinical data. The "ground truth" for this submission are
established engineering standards (e.g., IEC standards for electrical safety, EMC, etc.) and the characteristics of the predicate device.

8. The sample size for the training set:

Not applicable. No AI/ML algorithm training is mentioned.

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

Not applicable. No AI/ML algorithm training is mentioned.

In summary, this document is a regulatory submission for a physical medical device (X-ray unit) based on substantial equivalence, not an AI/ML device requiring clinical performance validation against acceptance criteria.

Summary

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September 1, 2023

Changzhou Sifary Medical Technology Co., Ltd. % Mr. Lee W. Strong Regulatory Dept Manager 510k FDA Inc. 156 E. Granada Blvd. ORMOND BEACH FL 32176

Re: K232068

Trade/Device Name: HyperLight Portable X-ray Unit Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: July 7, 2023 Received: July 12, 2023

Dear Mr. Strong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232068

Device Name HyperLight Portable X-ray Unit

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)

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510k FDA Consulting

Medical Device Clearances

156 East Granada Blvd.

Ormond Beach, FL 32176

386-506-8711

510(k) Summary - K232068

Submitter/Applicant

Changzhou Sifary Medical Technology Co., Ltd No.99 Qingyang Road, Xuejia County, Xinbei District Changzhou, Jiangsu, China 213000

Phone: + 86-186-02591004 Contact: Tao Huan, Head of Firm (simon@sifary.com)

Date Prepared: July 10, 2023

Preparer/Consultant

510K FDA Inc. 156 East Granada Blvd. Ormond Beach, FL 32176

Phone:

386-506-8711 Fax: (386) 675-4621 Lee Strong, Regulatory Dept. Mgr (lee@510kfda.com) Primary Contact: Secondary Contacts: Claude Berthoin, CEO (claude@denterpriseintl.com).

Device Classification

Trade/Model Names:	HyperLight Portable X-ray Unit
Common Name:	Portable X-ray System
Regulation Name:	Extra-oral Source X-ray System
Regulation Number:	21 CFR 872.1800
Primary Product Code:	EHD
Classification Name:	Unit, X-ray, Extraoral with Timer
Regulatory Class:	II
510k Review Panel:	Dental

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Predicate Device

The subject device claims equivalence to the following legally marketed predicate:

510(k) Number:	K180561
Applicant:	MobileX Portable X-ray System (Model T-100).
Date Cleared:	April 4, 2018
Regulation Name:	Extra-oral Source X-ray System
Regulation Number:	21 CFR 872.1800
Primary Product Code:	EHD
Classification Name:	Unit, X-ray, Extraoral with Timer
Regulatory Class:	II
510k Review Panel:	Dental

Indications for Use

The device 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 receptors. Its use is intended for both adults and pediatric subjects.

Intended Use

Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

Device Description

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Comparison of Technological Characteristics with Predicate

DeviceCharacteristic	Subject DeviceHyperLight PortableX-ray Unit	Predicate Device Mobile-X Portable X-ray System(K180561)	Comparison
510(k) Owner	Changzhou Sifary MedicalTechnology Co., Ltd.(China)	Denterprise International,Inc.(USA)	NA
Classification &Product Code	872.1800; EHD	872.1800; EHD	Similar
Intended Use	Intended as extraoral x-raysources to be used withintraoral image receptors fordiagnostic imaging bydentists or dentaltechnicians.	Intended as extraoral x-raysources to be used withintraoral image receptors fordiagnostic imaging bydentists or dentaltechnicians.	Similar
Indication for Use	The device is a diagnosticX-ray system which isintended to be used bytrained dentists and dentaltechnicians as an extra-oralX-ray source for producingdiagnostic x-ray imagesusing intra-oral receptors.Its use is intended for bothadults and pediatricsubjects.	The device is a diagnosticX-ray system, which isintended to be used bytrained dentists and dentaltechnicians as an extra-oralX-ray source for producingdiagnostic x-ray imagesusing intra-oral receptors.Its use is intended for bothadults and pediatricsubjects.	Similar
Size	11.85" x 4.58" x 9.97"	6.5" x 6.0" x 10.5"	Difference ofdesign, size
Source to SkinDistance	20 cm	20.5 cm	Difference .5 cm
Cone diameter	5.7 cm	6.0 cm	Difference .3 cm
DeviceCharacteristic	Subject DeviceHyperLight PortableX-ray Unit	Predicate Device Mobile-X Portable X-ray System(K180561)	Comparison
User interface	Up-down buttons forexposure time selectionwith timer display.Additionally, several user-selectable preset times withpatient size, and toothselection icons on an LCDdisplay.	Up-down buttons forexposure time selection withtimer display. Additionally,several user-selectablepreset times with patientsize, image-receptor type,and tooth selection icons onan LCD display.	Difference;subject devicedoes not setimage-receptortype
Backscatterradiation protection	159.5mm dia. 13mm thickPb-filled acrylic plasticscatter shield	153mm dia. 12mm thickPb-filled acrylic plasticscatter shield	6.5 mmdifference indiameter and 1mm difference inthickness
Exposure switch	Exposure trigger at thelower front area of the mainbody or remote switch.	Exposure button at frontcover on right hand side orremote switch.	Differentlocation
ElectricalInformation
Exposure time	0.02 ~ 2.0 secondsin .01-.40s increments (20steps)	0.01 ~ 1.3 seconds in 0.01or 0.05 increments	Difference;subject devicehas higherexposure time
Time accuracy	±5% or ±20ms, whichever is greater	± (10% +1 ms)	Slight difference
mA	2.5mA	2mA	Subject hasgreater mA
kVp	65kVp	70kVp	Subject haslesser kVp
Waveform	Constant Potential (DC)	Constant Potential (DC)	Similar
Total Filtration	1.8mmAl	1.5mmAl	Subject hasgreater TotalFiltration
DeviceCharacteristic	Subject DeviceHyperLight PortableX-ray Unit	Predicate Device Mobile-X Portable X-ray System(K180561)	Comparison
Performancestandards	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-65IEC 62304IEC 62366ISO 14971IEC 61223-3-4	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-65IEC 62304IEC 62366ISO 14971	Difference;subject devicetested toIEC61223-3-4

The following table compares technological and other characteristics of the subject and predicate device.

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The above comparison shows the subject and predicate devices have substantially similar technological characteristics. Differences show up in the shape, size, design of the device and those are in cm and mm measurements of slight difference. The exposure time is slightly less with the subject device matched to the predicate. The differences of the device are minor and do not raise new issues of safety and effectiveness.

Non-Clinical Performance Data

The following performance was completed on the subject device in support of the substantial equivalence determination of the predicate device. Clinical data was not needed to support substantial equivalence.

Electrical Safety and EMC
Software Validation ●
Biocompatibility ●
Usability
Clinical Comparison ●
Risk Assessment ●
. All tests were performed in accordance with ISO standards and tests are recognized by FDA.
None of the standards were adapted for application to the device under . review.
. There were no requirements of any standard that were not applicable to the device.

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No deviations from the standards were applied. ●
No differences exist between the tested device and the device to be marketed.
. Conformity with all standards was determined by the device manufacturer, Changzhou Sifary Medical Technology Co., Ltd
Electrical tests performed by TÜV Rheinland (Shanghai) Co., Ltd.

Specific Guidance Document

There are three FDA Specific Guidance Documents associated with the device:

Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held . Use. This manufacturer utilized this guidance to develop this device to ensure the safety of this device for both the operators and the patients.
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Details of this guidance are provided within the Software Validation Report.
Pediatric Information for X-ray Imaging Device Premarket Notifications. The . submission includes pediatric patients in the Indications for Use and labelling.

Labels

The labels on the device show that this device conforms to the following:

21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products,

21 CFR 1020.30: Diagnostic x-ray systems and their major components,

21 CFR 1020.31: Radiographic Equipment

Substantial Equivalence

The above comparison chart shows the subject and predicate devices are substantially equivalent in technological characteristics.

Both devices have:

The same function and used in the same environment.
The same indications for use and the same intended use. ●
The same manufacturing process and technological characteristics. ●
Both devices have completed the ISO standardized testing and have passed ● and the tests are in the comparison chart shown above.

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Conclusion

The subject and predicate device have the same indications for use, the same intended use and the same technological characteristics. The HyperLight Portable X-ray Unit performs the same identical functions, in the same environment as the predicate device. HyperLight Portable X-ray Unit uses the same technology as the predicate device, based on well-known technology. HyperLight Portable X-ray Unit is as safe and effective as the predicate device. We believe the subject device does not introduce any new safety concerns and is substantially equivalent to the predicate device. In conclusion, the subject device, HyperLight Portable X-ray Unit, is at least as safe and effective as the predicate device and warrants a finding of substantial equivalence to the legally marketed 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.