The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.

Device Description

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan and process image data contained in the intraoral imaging plate. Once the intraoral imaging plate is inserted into the entrance of the scanner, the scanning program will be started to progressively scan the imaging plate, and move forward in the meantime to scan the imaging plate completely with the laser beam in a specified time. In the place where the laser is irradiated, blue fluorescence will be excited and the intensity of the fluorescence brightness is linearly related to the image data density at that point. The fluorescence will be collected by a high-efficiency photoconductor, which is positioned along the laser scanning line and then will be introduced into a photomultiplier tube, where it will be converted into a corresponding electrical signal. After the electrical signal is converted by A/D (analog/digital) converter in the electrical circuit, it can be used for digital image processing and then output to the image display, storage, or transmission communication system.

This Dental Image Plate Scanner, Model DFC-4T-SMART mainly consists of image plate scanner, power adapter, intraoral imaging plate and Dental image plate scanner control system software (Version: V1.0).

The image plate scanner is composed of lasers, optical scanners, photomultiplier tubes, amplifiers, A/D converters, image processing unit and output interfaces etc.

Dental image plate scanner control system software (DFC software) is mainly used to acquire and display the image data of the intraoral imaging plate as well as used for patient management, examination management, image storage, image printing etc. Dental image plate scanner control system software (Version: V1.0) is of Moderate level of concern.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Dental Image Plate Scanner, Model DFC-4T-SMART. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria, particularly for an AI-powered device.

This document is a regulatory submission for a scanner, which converts X-ray latent images on an imaging plate into digital images. It is not an AI-powered device for image analysis or diagnosis. Therefore, the detailed requirements for AI device testing (like MRMC studies, expert consensus for ground truth, or specific performance metrics like sensitivity/specificity for disease detection) are not present or applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (another image plate scanner) based on technological characteristics and non-clinical bench testing to ensure safety and performance of the hardware and scanner functionalities.

Based on the provided text, I cannot fulfill your request as it pertains to acceptance criteria and study proving an AI device meets those criteria.

The document states:

"No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its predicate device." This explicitly states no clinical trials were done.
The non-clinical testing listed focuses on electrical safety (IEC 60601-1, IEC 60601-1-2), laser safety (IEC 60825-1), photobiological safety (IEC 62471), risk analysis (ISO 14971), and software/cybersecurity guidelines. These are general safety and performance standards for a medical device, not specific performance metrics for an AI-driven diagnostic or analytical tool.
The "Image Quality" metric is "≥12lp/mm" (line pairs per millimeter) and "Pixel Size" is "35μm". These are characteristics of the scanner's resolution, not performance metrics of an AI algorithm interpreting the image. MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) are also listed as image quality parameters of the scanner itself.

If you can provide a document for an AI-powered medical device, I would be able to answer your request.

Summary

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March 2, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Hefei DentaFilm Medical Equipment Co., Ltd. % Ming Chang Qiu Management Representative No. 98 Tangkou Road, Economic and Technological Development Zone Hefei, Anhui 230601 CHINA

Re: K214091

Trade/Device Name: Dental Image Plate Scanner, Model DFC-4T-SMART Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 5, 2022 Received: January 5, 2022

Dear Ming Qiu:

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

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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) 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 (OS) 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K214091

Device Name

Dental Image Plate Scanner, Model DFC-4T-SMART

Indications for Use (Describe)

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

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K214091

Hefei DentaFilm Medical Equipment Co., Ltd

Dental Image Plate Scanner, Model DFC-4T-SMART

Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: II Product Code: MUH Traditional 510(K) Submission Files

SECTION 5

510(k) Summary or 510(k) Statement

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510(k) Summary

Submission Number: K214091

Submitter

Name: Hefei DentaFilm Medical Equipment Co., Ltd

Address: No. 98 Tangkou Road, Economic and Technological Development Zone,

230601 Hefei City, Anhui Province, People's Republic of China

Name of contact person: Ming Chang Qiu

Telephone: +86-551-63528008

Submission date: 2022-01-26

Device

Device trade name: Dental Image Plate Scanner, Model DFC-4T-SMART

Regulation Name: Extraoral Source X-ray System

Regulation class: 2

Regulation number: 21CFR 872.1800

Panel: Radiology

Product code: MUH

Predicative device

Predicate Submission Number: K192766 Predicate Device Trade Name: Digital Intraoral Imaging Plate System, Model F200, F210 Regulation Name: Extraoral Source X-ray System Regulation number: 21CFR 872.1800 Panel: Radiology Product code: MUH

Device description

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan and process image data contained in the intraoral imaging plate. Once the intraoral imaging

Traditional 510(K) Submission Files

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plate is inserted into the entrance of the scanner, the scanning program will be started to progressively scan the imaging plate, and move forward in the meantime to scan the imaging plate completely with the laser beam in a specified time. In the place where the laser is irradiated, blue fluorescence will be excited and the intensity of the fluorescence brightness is linearly related to the image data density at that point. The fluorescence will be collected by a high-efficiency photoconductor, which is positioned along the laser scanning line and then will be introduced into a photomultiplier tube, where it will be converted into a corresponding electrical signal. After the electrical signal is converted by A/D (analog/digital) converter in the electrical circuit, it can be used for digital image processing and then output to the image display, storage, or transmission communication system.

The image plate scanner is composed of lasers, optical scanners, photomultiplier tubes, amplifiers, A/D converters, image processing unit and output interfaces etc.

Indication for use

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to be used to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.

Attribute	Subject device	Predicative device	Discussion/Conclusion
Product name	Dental Image PlateScanner, ModelDFC-4T-SMART	Digital IntraoralImaging Plate System,Model F200, F210	/
Manufacturer	Hefei DentaFilm	Fussen Technology Co.,	/
DentaFilmSection 5 510(k) Summary
Attribute	Subject device	Predicative device	Discussion/Conclusion
	Medical EquipmentCo., Ltd	Ltd.
510(k) number	K214091	K192766	/
Deviceclassificationname	Class II	Class II	Same
Classificationregulations	21 CFR 872.1800	21 CFR 872.1800	Same
Product code	MUH	MUH	Same
Product picture	Image: DentaFilm	Image: FUSSEN	/
Similarities
Indication forUse	The Dental ImagePlate Scanner isintended to be used toscan dental X-raylatent imagescontained in theintraoral imaging plateand then generate,browse, process andreview the intraoraldental digital X-rayimage.	Digital Intraoral ImagingPlate System is indicatedfor capturing, digitizationand processing ofintraoral x-ray imagesstored in imaging platerecording media.	Samemeaning
Intended user	The Dental ImagePlate Scanner isexpected to be usedonly by professionallyqualifieddental/medical staffs.Typical user is a dentalassistant with specifictraining for usingdental diagnostic	It is intended for uses inhospitals and clinics, andshall be operated and usedby trained professionalswith physician'sguidance.	Samemeaning
DentaFilm			Section 5 510(k) Summary
Attribute	Subject device	Predicative device	Discussion/Conclusion
Workingprinciple	The Dental ImagePlate Scanner isintended to scan andprocess image datacontained in theintraoral imagingplate. Once theintraoral imaging plateis inserted into theentrance of thescanner, the scanningprogram will be startedto progressively scanthe imaging plate, andmove forward in themeantime to scan theimaging platecompletely with thelaser beam in aspecified time. In theplace where the laser isirradiated, bluefluorescence will beexcited and theintensity of thefluorescencebrightness is linearlyrelated to the imagedata density at thatpoint. Thefluorescence will becollected by a high-efficiencyphotoconductor, whichis positioned along thelaser scanning line andthen will be introducedinto a photomultipliertube, where it will beconverted into acorrespondingelectrical signal. After	The imaging platescanner functions asinterpreting the latentimage information storedin the imaging plate, andit consists of laser, opticalscanner, photomultiplier,amplifier, A/D converter,image processing unit,output interface, etc.After a phosphor imagingplate is loaded into theimaging plate scannerinlet, start the scanningprogram to scan theimaging plate with latentimage information to beinterpreted row by row,move forwards at thesame time, and it can becompletely scanned bythe laser beams oncewithin set time. Blueflorescence can beexcited from partsradiated by the laser, andthe intensity of theflorescence brightness isin linear relationship withthe density of the latentimage information at thepoint. The florescence iscollected by efficientphotoconductor arrangedalong laser scanning line,is introduced into thephotomultiplier, and isfurther converted intocorresponding electricsignals. After beingtransmitted into circuit	Samemeaning
Attribute	Subject device	Predicative device	DiscussionConclusion
Attribute	the electrical signal isconverted by A/D(analog/digital)converter in theelectrical circuit, it canbe used for digitalimage processing andthen output to theimage display, storage,ortransmissioncommunicationsystem.	A/D (analog/digital)signal conversion, theelectric signals can beused in digital imageprocessing, and can beoutput to image display,storage or transmissioncommunication system.
Productstructure	The image platescanner is composedof lasers, opticalscanners,photomultiplier tubes,amplifiers, A/Dconverters, imageprocessing unit andoutput interfaces etc.	The imaging platescanner consists of laser,opticalscanner,photomultiplier,amplifier, A/D converter,image processing unit,output interface, etc.	Same
Softwarefunction design	Dental image platescanner control systemsoftware (DFCsoftware) is mainlyused to acquire anddisplay the image dataof the intraoral	Digital intraoral imagingplate control systemsoftware (CRFC) ismainly used to readimages from oral imagingplate and for patient andexamination management	Same
DentaFilm Section 5 510(k) Summary
Attribute	Subject device	Predicative device	Discussion/Conclusion
scanningplate reuse.
Transport/feedmechanism ofimaging plate	Imaging plate tray	Imaging plate holdinggroove	Same
Imaging plate	Intra Oral DentalPhosphor PlatesSize 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mmSize 3: 27 x 54 mm	Intra Oral DentalPhosphor PlatesSize 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mmSize 3: 27 x 54 mm	Same
Image data bitdepth	14 bits/pixel	14 bits/pixel	Same
Datatransmissioninterface	USB 2.0 port	USB 2.0 port	Same
Communication	DICOM3.0	DICOM3.0	Same
PatientContaminationprevention	In order to ensurehygiene, the imagingplate must be packedin an imaging plateprotective bag duringexposure procedure.	Use a barrier envelope topack an imaging plate inorder to ensure sanitation.	Samemeaning
Differences
Product size andweight	size (H×W×D):296×170×196mm;Wight: ≤7kg	size (H×W×D):260×167×325mmWeight: 5.2kg	differences onproduct size andweight willnot affect theperformanceand safety ofthe scannertotally.
Imagingscanning	Laser/PhotomultiplierTube	Laser/PhotomultiplierTube	Same
Image Quality	≥12lp/mm	12lp/mm	Same
Pixel Size	35μm	35μm	Same
MTF	≥41% at 3 lp/mm	not publicly available	The scanneris only usedto transfer therecordedimage in the
DentaFilm	Section 5 510(k) Summary
Attribute	Subject device	Predicative device	Discussion/Conclusion
DQE	More than 9% at 3 lp/mm	not publicly available	image plate, and will not adversely affect the image quality as demonstrated by the solid-state device testing. The scanner is only used to transfer the recorded image in the image plate, and will not adversely affect the image quality as demonstrated by the solid-state device testing.
ImagingSoftware	DFC Software V1.0	CRFC V2.0.2	software is evaluated and validated according to the FDA Guidance. Such difference will not affect the performance and safety of the device.
External powersource	Power adapter:input 100-240 V AC, 50/60Hz,1.4-0.7AOutput: 15V	Power adapter:Input 100-240V ~ 47-63Hz 1.62-0.72AOutput: DC15V 4.2A	slight difference on power adapter will
Attribute	Subject device	Predicative device	Discussion/Conclusion
	4.0A;60W MAX.	max. 63W	not affect theeffectivenessand safety ofthe device.

Comparison of technological characteristics with the predicate device

Traditional 510(K) Submission Files

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and image storage and

the recorded image plate

is scanned using a laser.

printing.

imaging plate as well |

as used for patient

storage, image printing

the recorded image

plate is scanned using

image

management, examination management,

etc.

scan

Image

design

DentaFilm

Same

erasing

Section 5 510(k) Summary

ﮐﮯ ﺑ

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Section 5 510/k) Summa

The subjective device and predicative device have the same intended use. The subject and predicative device have similar technological characteristics as evidenced by the table above. The differences in technological characteristics do not raise different questions of safety or effectiveness. Detailed information on difference discussion and conclusion refer to section 12 Substantial equivalence discussion.

Summary of non-clinical testing (Performance testing-bench)

The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.

Risk Analysis developed in accordance with ISO 14971:2019. .
IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests
. IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
IEC 62471: 2006 Photobiological safety of lamps and lamp systems ●
Software development: Guidance for the Content of Premarket Submissions ● for Software Contained in Medical Devices.
Cybersecurity: Content of Premarket Submissions for Management of ● Cybersecurity in Medical Devices.

Summary of clinical testing

No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its predicate device.

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Conclusions

The differences between the subjective device and its predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed 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.