The OpenSensorX Series is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.

Device Description

OpenSensorX series are digital intra-oral sensors. It features a 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 optional iRay intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of the OpenSensorX series is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software. The OpenSensorX series has two device models, OpenSensor0001X and OpenSensor0002X.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria in a structured format. The document is primarily a 510(k) summary for the OpenSensorX Series, focusing on establishing substantial equivalence to a predicate device. It describes general non-clinical studies and states that clinical data is not needed.

However, I can extract the non-clinical considerations from Section 9, which lists performance parameters tested against standard requirements to establish substantial equivalence. These can be interpreted as implicit acceptance criteria for maintaining equivalence with the predicate device.

Here's the information extracted and organized to best fit your request:

Acceptance Criteria and Device Performance

The "Nonclinical Considerations" section (Section 9.3) outlines various performance aspects that were tested to demonstrate substantial equivalence to the predicate device (DentiMax Digital X-ray Imaging System, K092547). While the specific acceptance values are not always explicitly stated (e.g., "meet standard requirements" or "assured the same as the predicate device"), the reported performance indicates that the OpenSensorX series meets or is substantially equivalent to the predicate for these criteria.

Acceptance Criteria (Implied from Non-clinical Studies)	Reported Device Performance (OpenSensorX Series)
Electrical Safety & EMC	Met standard requirements (IEC/ES 60601-1, IEC60601-2-65, IEC 60601-1-2)
Biocompatibility (Patient Contact Materials)	Evaluated with ISO10993-1; results assured safety same as predicate.
Sensor Position Frame Safety	Evaluated and assured same as predicate device.
Dose to Output Signal Transfer Function	Demonstrated substantial equivalence to predicate device.
Signal to Noise Ratio (SNR)	Demonstrated substantial equivalence to predicate device.
Uniformity	Demonstrated substantial equivalence to predicate device.
Defect	Demonstrated substantial equivalence to predicate device.
Minimum Triggering Dose Rate	Demonstrated substantial equivalence to predicate device.
Modulation Transfer Function (MTF)	0.1 at 12.5lp/mm (Predicate: 0.1 at 7lp/mm) - Note: This indicates an improvement in spatial frequency response.
Spatial Resolution	Demonstrated substantial equivalence to predicate device.
Low Contrast Resolution	Demonstrated substantial equivalence to predicate device.
Image Acquisition Time	Demonstrated substantial equivalence to predicate device.
Software Hazard Classification	Hazards classified, requirements and design specifications defined and passed all test cases, complying with intended design.

Study Details

The provided text describes non-clinical studies performed to establish substantial equivalence, rather than a clinical study or a comparative effectiveness study with human readers.

Sample size used for the test set and the data provenance: Not explicitly stated for each non-clinical test. The tests are described generally (e.g., "Electrical, mechanical, environmental safety and performance testing"). The product is an intraoral X-ray sensor; thus, the "test set" would refer to the physical devices themselves and the images generated by them under various conditions, rather than a dataset of patient images in the typical sense of AI/clinical studies. Data provenance is not specified beyond being "non-clinical."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned are primarily engineering and performance tests (e.g., electrical safety, EMC, sensor performance metrics). Ground truth, in this context, would be established by validated test equipment and standard measurement protocols.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for expert interpretation, which is not relevant for the described non-clinical performance and safety tests.
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. The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence." This indicates no clinical study, and therefore no MRMC study, was performed. The device is an image acquisition sensor, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in effect. The performance metrics (MTF, SNR, uniformity, etc.) are inherent characteristics of the device itself, measured objectively without human interpretation or intervention in the measurement process. The software component also underwent verification and validation tests independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance tests, the "ground truth" is based on established engineering standards, physical measurements, and comparison to the performance specifications of the predicate device. For biocompatibility, it's based on ISO 10993-1. For software, it's based on predefined requirements and design specifications.
The sample size for the training set: Not applicable. This device is an X-ray sensor, not an AI/ML algorithm that requires a training set in the conventional sense. The software mentioned (iRayDR) handles image acquisition, enhancement, analysis, and viewing, implying more traditional software engineering and validation rather than machine learning.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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April 13, 2022

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

DentiMax, Inc. % Mr. David Arnett President 4115 E Valley Auto Dr, Suite 101 MESA AZ 85298

Re: K220556

Trade/Device Name: OpenSensorX Series Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: March 18, 2022 Received: March 23, 2022

Dear Mr. Arnett:

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 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

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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 medical devices and radiation-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) K220556

Device Name OpenSensorX Series

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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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

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

February 23, 2022

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

Company Name:	DENTIMAX, INC.
Company Address:	4115 E. Valley Auto Drive, Suite 101 Mesa AZ 85206
Contact Person:	David J. Arnett
Phone:	(480) 396-1798
Email:	david@dentimax.com

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

Trade Name:	OpenSensorX Series
Common Name:	Intraoral X-Ray Imaging System
Model Name:	OpenSensorX series
Classification Name:	Extraoral Source X-ray System
Product Code:	MUH
Regulation Number:	21 CFR 872.1800
Device Class:	II

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

The identification predicates within this submission are as follows:

Manufacturer:	DENTIMAX, INC.
Trade Name:	DentiMax Digital X-ray Imaging System
Model Name:	SENSORH1
	SENSORH2
Product Code:	MUH
Classification Name:	Extraoral Source X-ray System
FDA 510 (k) #:	K092547

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

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

6.1. Intended Use

6.2. Suitable patient

This device is suitable for both adult and pediatric, but not suitable for pregnant women.

6.3. Processing of input and output

The sensor plate of OpenSensorX series are 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 processed by connecting to scanning and readout

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electronics, consequently to form a panel image by transmitting to PC through the user interface.

When OpenSensorX series work continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.

Item	Predicate Device:DentiMax Digital X-Ray ImagingSystem	Proposed Device:OpenSensorX Series
510(K) Number	K092547	To be assigned
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:	CCD and thin FOP(fiber opticplate)	CMOS Photodiode Array
Dimensions:	SENSORH1:41mm×26.4mm×5.8mmSENSORH2:42.3mm×30mm×5.8mm	OpenSensor0001X:38.5mm×25mm×4.5mmOpenSensor0002X:40mm×31mm×4.5mm
Image Matrix Size:	1500×1000 pixels for SENSORH1;1700×1200 pixels for SENSORH2	1500×1000 pixels forOpenSensor0001X;1800×1300 pixels forOpenSensor0002X
Pixel Pitch:	20μm	20μm
EffectiveImagingArea:	30mm×20mm for SENSORH1;34mm×24mm for SENSORH2	30mm×20mm forOpenSensor0001X;35mm×26mm forOpenSensor0002X
ModulationTransferFunction (MTF)	0.1 at 7lp/mm	0.1 at 12.5lp/mm
Item	Predicate Device:DentiMax Digital X-Ray ImagingSystem	Proposed Device:OpenSensorX Series
Power Consumption:	DC +4.5 to 5.5V(480mA Max.)	5V DC, 400mA
Communications:	USB 2.0	Same
Protection against shock	Type BF applied part	Type BF applied part
Operation:	Temperature: 0 to 50°CHumidity: 0 to 70% (Non-Condensing)	Temperature: 10 to 35°C
		Humidity: 20 to 90% (Non-Condensing)
		Atmospheric pressure: 70 to 106 kPa
		Altitude: Max. 3000 meters
		Storage andTransportation:( detector )
Humidity: 10 to 95%(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters
Software	XRAY Vision Software(XVA3TM)

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

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System requirements to operate with other radiographic system components 8.

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 OpenSensorX series are compatible with the X-ray generators with the specifications described above.

1. Application Program Interface (API) for system integration manufacturer
  Peripheral hardware: OpenSensorX series connected via USB2.0 communication.

Operating System:	Windows 7 or above 32/64bit
CPU:	Intel Core i5 3.6G
Memory:	8G DDR3
Hard Disk:	640 G
USB port:	in accordance with USB2.0 interface

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1. X-ray exposure mode
  The AED mode can connect X-ray signal in the OpenSensorX series. Once there the X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the intraoral sensor. Until the exposure is finished, the sensor will receive a signal which represents the end of exposure from the inner trigger module and begin to acquire the image.

9. Nonclinical study

1. Electrical Safety and EMC testing:
  Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-65 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results 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 same as the predicate device.

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 OpenSensorX series are substantially equivalent to the predicate devices on the Market (K092547):

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 iRayDR classifies the hazards, defines requirements specification and design specification, all the specification pass all the

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test cases and complies the intended design specification.

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.

10. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Dentimax Inc. Concludes that OpenSensorX series are substantially equivalent to predicate device with regards to safety and effectiveness.

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.