Dental Sensors, models NanoPix1 and NanoPix2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygenrich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric.

Device Description

Dental Sensors, models NanoPix1 and NanoPix2, are feature 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hi-speed direct USB interface enables a simple connection to a PC without need for an additional control box. The intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of NanoPix1 and NanoPix2 are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of NanoPix system, enables to complete the digitalization of the medical X-ray imaging with the NanoPix software.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Dental Sensors NanoPix1 and NanoPix2. This documentation primarily focuses on establishing substantial equivalence to a predicate device (Digital Intraoral X-ray Imaging System, models Pluto0001X and Pluto0002X, K210312), rather than detailing an independent study to prove the device meets specific acceptance criteria in the way a de novo or PMA submission might.

Therefore, the information you're requesting regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a study proving the device performance is largely not present in the provided 510(k) summary.

However, I can extract the information that is available, including the performance characteristics that were compared to establish substantial equivalence.

Here's a breakdown of the available information:

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

Since this is a 510(k) for substantial equivalence, formal "acceptance criteria" for a specific study proving novel performance are not explicitly stated. Instead, the performance of the proposed devices (NanoPix1, NanoPix2) is compared to the predicate device (Pluto0001X, Pluto0002X) to demonstrate that they are technologically similar and perform equivalently. The "acceptance criteria" here implicitly align with matching or performing comparably to the predicate device.

Performance Characteristic	Predicate Device Performance (Digital Intraoral X-Ray Imaging System Pluto0001X/Pluto0002X)	Proposed Device Performance (Dental Sensors NanoPix1/NanoPix2)	Comparison/Acceptance
Pixel Pitch	20μm	20μm	Same
Spatial Resolution	16lp/mm	16lp/mm	Same
Modulation Transfer Function (MTF)	0.1 at 12.5lp/mm	0.1 at 12.5lp/mm	Same
Image Matrix Size (NanoPix1/Pluto0001X)	1500×1000 pixels	1500×1000 pixels	Same
Image Matrix Size (NanoPix2/Pluto0002X)	1800×1300 pixels	1800×1300 pixels	Same
Effective Imaging Area (NanoPix1/Pluto0001X)	30mm×20mm	30mm×20mm	Same
Effective Imaging Area (NanoPix2/Pluto0002X)	36mm×26mm	36mm×26mm	Same
Detector Structure	CMOS Photodiode Array	CMOS Photodiode Array	Same
X-Ray Absorber (Scintillator)	CsI	CsI	Same
Power Consumption	5V DC, 400mA	5V DC, 400mA	Same
Communications	USB 2.0	USB 2.0	Same
Cooling	Air cooling	Air cooling	Same
Protection against Water/Matter	IP68	IP68	Same
Protection against Shock	Type BF applied part	Type BF applied part	Same
Operating Temperature	10 to 35℃	10 to 35℃	Same
Operating Humidity	20 to 90% (Non-Condensing)	20 to 90% (Non-Condensing)	Same
Operating Atmospheric pressure	70 to 106 kPa	70 to 106 kPa	Same
Operating Altitude	Max. 3000 meters	Max. 3000 meters	Same
Storage and Transportation Temperature	-10 to 55°C	-20 °C ~ 55 °C	Narrower range (proposed)Still considered equivalent
Storage and Transportation Humidity	10 to 95% (Non-Condensing)	20% ~ 80% (Non-Condensing)	Narrower range (proposed)Still considered equivalent
Storage and Transportation Atmospheric pressure	70 ~ 106 kPa	70kPa~106kPa	Same
Storage and Transportation Altitude	Max. 3000 meters	Max. 3000 meters	Same

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states that "Non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles". This typically refers to bench testing and physical measurements of the device's characteristics (like spatial resolution, MTF, signal-to-noise ratio, etc.). It does not mention a specific "test set" in terms of patient data or clinical images, nor does it detail sample sizes for such a set or data provenance.

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

This information is not provided. As no clinical test set is detailed, there's no mention of experts establishing ground truth for such a set.

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

This information is not provided, as no clinical test set is detailed.

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 study was reported or indicated. The submission is for a dental sensor (hardware plus basic image viewing software), not an AI-powered diagnostic tool. The software described is for image acquisition, enhancement, viewing, and reporting, not for automated diagnosis or assistance in a way that would require a comparative effectiveness study with human readers.

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

The device is a dental sensor and associated software for image viewing and manipulation. It is not an algorithm designed for standalone diagnostic performance. Thus, a standalone algorithm performance study is not applicable or mentioned.

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

For the non-clinical studies mentioned, the "ground truth" would be scientific and engineering measurements based on established standards for imaging device performance (e.g., direct measurement of spatial resolution, MTF, signal-to-noise ratio). There is no mention of clinical ground truth (like pathology or expert consensus on clinical images) as clinical studies were not deemed necessary for this 510(k) submission.

8. The sample size for the training set:

This information is not applicable and not provided. The device is an imaging sensor, not a machine learning model that requires a training set in the conventional sense. The "NanoPix software" mentioned performs image processing, viewing, and management functions, not AI-driven diagnostic tasks that would necessitate a large training dataset for model development.

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

This information is not applicable and not provided, as there is no mention of a training set for a machine learning model.

Summary

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March 11, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.

iRay Technology Taicang Ltd. % Wei Pan Registration and Regulatory Affairs Deputy Director No.33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K220422

Trade/Device Name: Dental Sensors NanoPix1, NanoPix2 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: February 8, 2022 Received: February 14, 2022

Dear Wei Pan:

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)

K220422

Device Name

Dental Sensors NanoPix1, NanoPix2

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

Dental Sensors, models NanoPix2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for dagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental

personnel, and not used in the oxygenrich environment.

This device is suitable for providing dental radiography imaging for both adult and pediatric.

	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K220422

SECTION 4 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

SECTION 4 - 1 of 8

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

1. Date Prepared [21 CFR 807.92(a)(1)]

February 8, 2022

2. Submitter's Information [21 CFR 807.92(a)(1)]

Company Name:	iRay Technology Taicang Ltd.
Company Address:	No.33 Xinggang Road, Taicang Port Economic and
	Technological Development Zone, Jiangsu, China 215434
Contact Person:	Guo Wu
Phone:	0512-53698213
Fax:	0512-53690872
Email:	guo.wu@iraygroup.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	Dental Sensors NanoPix1, NanoPix2
Common Name:	Extraoral Source X-Ray System
Model Name:	NanoPix1, NanoPix2
Classification Name:	Extraoral Source X-Ray System
Product Code:	MUH
Regulation Number:	21 CFR 872.1800
Device Class:	Class II
FDA 510 (k) #:	K220422

SECTION 4 - 2 of 8

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4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification predicates within this submission are as follows:

Manufacturer:	iRay Technology Co., Ltd.
Trade Name:	Digital Intraoral X-ray Imaging System
Model Name:	Pluto0001XPluto0002X
Product Code:	MUH
Classification Name:	Extraoral Source X-Ray System
Regulation Number:	21 CFR 872.1800
Device Class:	Class II
FDA 510 (k) #:	K210312

5. Description of the Device [21 CFR 807.92(a)(4)]

	NanoPix1	NanoPix2
Dimensions	38.5mm×25mm×4.5mm	40mm×31mm×4.5mm
Image Matrix Size	1500×1000 pixels	1800×1300 pixels
Effective Imaging Area	30mm×20mm	36mm×26mm

There are the following differences between NanoPix1 and NanoPix2

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NanoPix software is currently not FDA-cleared, according to 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', the level of software concern is Moderate.

NanoPix software is part of the NanoPix Dental Sensor. It is provided to the user with the sensor as a supporting software, and cooperates with the hardware to complete the basic functions of the Dental sensor. The main functions of NanoPix software are as follows,

· Patient menu: record and manage the basic information of the patient;
· Acquisition menu: acquire dental X-ray images from the sensor or import images from external files, select teeth layout and teeth position;

· Viewer menu: process images, such as rotate, flip, pan and zoom the images, annotate and measure the images, set the brightness, contrast, smooth, inverse of the images;

· Report menu: create and print the report. Besides, NanoPix software also has Search function and Tools setting function to set the Environment, Patient, Acquisition, Viewer and Report.

6. Intended Use [21 CFR 807.92(a)(5)]

Indications for use

Dental Sensors, models NanoPix1 and NanoPix2 are intended to collect dental xray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygenrich environment.

This device is suitable for providing dental radiography imaging for both adult and pediatric.

Processing of input and output

The sensor plate is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within CMOS panel, which are composed and

SECTION 4 - 4 of 8

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processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. When NanoPix1/ NanoPix2 work continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.

Item	Predicate Device:Digital Intraoral X-Ray ImagingSystemPluto0001X、Pluto0002X	Proposed Device:Dental SensorsNanoPix1、NanoPix2
Model name	Pluto0001X & Pluto0002X	NanoPix1 & NanoPix2
510(K) Number	K210312	K220422
ClassificationName	Extraoral Source X-ray System	Same
Product Code	MUH	Same
Regulation Number	21 CFR 872.1800	Same
Panel	Radiology	Same
Classification:	II	Same
X-Ray Absorber(Scintillator):	CsI	Same
Installation Type:	Portable	Same
Detector structure:	CMOS Photodiode Array	Same
Dimensions:	Pluto0001X:38.5mm×25mm×4.5mmPluto0002X:40mm×31mm×4.5mm	NanoPix1:38.5mm×25mm×4.5mmNanoPix2:40mm×31mm×4.5mm
Image Matrix Size:	1500×1000 pixels for Pluto0001X1800×1300 pixels for Pluto0002X	1500×1000 pixels for NanoPix11800×1300 pixels for NanoPix2
Pixel Pitch:	20μm	Same
Effective ImagingArea:	30mm×20mm for Pluto0001X;36mm×26mm for Pluto0002X;	30mm×20mm for NanoPix1;36mm×26mm for NanoPix2;
Spatial resolution	16lp/mm	Same
ModulationTransferFunction (MTF)	0.1 at 12.5lp/mm	Same

Item	Predicate Device:Digital Intraoral X-Ray ImagingSystemPluto0001X、Pluto0002X	Proposed Device:Dental SensorsNanoPix1、NanoPix2
Power Consumption:	5V DC, 400mA	Same
Communications:	USB 2.0	Same
Cooling:	Air cooling	Same
Protectionagainstmatter/Water	IP68	Same
Protectionagainstshock	Type BF applied part	Same
Operation:	Temperature: 10 to 35℃Humidity: 20 to 90% (Non-Condensing)Atmospheric pressure: 70 to 106kPaAltitude: Max. 3000 meters	Same
Storage andTransportation:( detector )	Temperature: -10 to 55°CHumidity: 10 to 95%(Non-Condensing)Atmospheric pressure: 70 ~ 106kPaAltitude: Max. 3000 meters	Temperature: -20 °C ~ 55 °CHumidity: 20% ~ 80%(Non-Condensing)Atmospheric pressure:70kPa~106kPaAltitude: Max. 3000 meters
Software	iRayDR	NanoPix Software

7. Technological Characteristic [21 CFR 807.92(a)(6)]

SECTION 4 - 5 of 8

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8. System requirements to operate with other radiographic system components

1. Recommended Generator Specification:
  Energy range: 55~100kV

mA range: 10~1000mA (depending on the generator power)

ms range: 10~~6300ms to produce 0.1~~1000mAs (depending on the generator power) Note: To our best knowledge, the NanoPix1 & NanoPix2 are compatible with the Xray generators with the specifications described above.

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1. Application Program Interface (API) for system integration manufacturer Peripheral hardware: the NanoPix1 & NanoPix2 connected via USB2.0 communication.

Operating System:	Windows® 7 or above
CPU:	Intel® Core 2
Memory:	2 GB or above
Hard Disk:	320 GB or above
USB port:	4 high-speed USB 2.0 ports

1. X-ray exposure mode
  The AED mode can connect X-ray signal in the NanoPix1 & NanoPix2. Once there is X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the intraoral sensor. Following the end of the x-ray exposure, the sensor will receive a signal from the inner trigger module which represents the end of exposure and begins the digital image conversion.

9. Nonclinical study

Electrical Safety and EMC testing: 1)
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC 60601-2-65 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
1. Biological Evaluation:
  Although there is a single-use protective sheeth prior to each use, the materials of the intra-oral sensor enclosure which may contact patient's oral mucosa have been evaluated with the ISO10993-1. And the evaluation results and test result assured the safety the same as the predicate device.

The sensor position frame is evaluate and assured the safety the same as the predicate device.

SECTION 4 - 7 of 8

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1. Nonclinical Considerations:
  According to the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, the non-clinical studies have been performed and the results have shown that the NanoPix1 & NanoPix2 are substantially equivalent to the predicate devices on the Market (K210312):

Dose to output signal transfer function. Signal to noise ratio, uniformity. Defect. Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time.

According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software NanoPix classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification.

According to the Guidance for the Pediatric Information for X-ray Imaging Device Premarket Notifications, the pediatric capabilities and labeling requirements were considered during the design and development process, the related information is shown in the User's manual.

1. Clinical Consideration:
  Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles, and indicates substantial equivalence to the predicate detectors Pluto.

10. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Changzhou Sifary Medical Technology Co., Ltd. Concludes that NanoPix1 & NanoPix2 are substantially equivalent to predicate device with regards to safety and effectiveness.

SECTION 4 - 8 of 8

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.