I-View Gold sensors are digital dental intraoral sensors 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.

Device Description

The subject I-View Gold and Imagen Gold sensors are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port: and (2) an Image Management Software package.

The subject comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm² and two brand names.

Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure.

AI/ML Overview

This document describes the marketing clearance for the I-View Gold and Imagen Gold Dental Sensors (K200625). The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (EzSensor Classic, K153060), rather than providing detailed acceptance criteria and a standalone study proving the device meets those specific acceptance criteria for performance metrics like diagnostic accuracy.

The FDA's 510(k) clearance process primarily evaluates whether a new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It does not typically require the applicant to establish novel performance acceptance criteria or conduct a de novo clinical study to prove those criteria are met, especially for devices with well-understood technology and established clinical pathways like dental X-ray sensors.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy for a specific clinical task) is not found in this 510(k) summary. The document focuses on demonstrating that the new device functions similarly and is as safe and effective as the predicate based on bench testing (SSIX Report, electrical safety, EMC, software documentation) and comparison of technical specifications.

Here's a breakdown of what can be extracted about "acceptance" and "testing" from the provided document, framed within the substantial equivalence argument, and what information is not available:

Information Available/Inferred from the Document:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied for Substantial Equivalence): The implicit "acceptance criterion" is that the technological characteristics and performance are comparable to the predicate device (EzSensor Classic, K153060) to ensure equivalent safety and effectiveness.
Reported Device Performance (Comparative Metrics): The table Compares technological characteristics. The "performance" here refers to measured physical and technical parameters, not diagnostic accuracy. The reported values for the subject device are expected to be sufficiently similar to the predicate to establish equivalence.

Characteristic	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (Subject Device)	Predicate Device Performance
Common Name	Intraoral Digital X-Ray Sensor	Intraoral Digital X-Ray Sensor	Intraoral Digital X-Ray Sensor
Indications for Use	Same as predicate	Same as predicate	Same as subject
Intended Use	Same as predicate	Same as predicate	Same as subject
Principles of operation	Same as predicate ('X-ray radiation => scintillator => fiber optic => CMOS => electronics => PC')	Same as predicate	Same as subject
Sensor Thickness (mm)	4.8 mm	4.8	4.8
USB Module	Integrated USB 2.0 module	Integrated USB 2.0 module	Integrated USB 2.0 module
Pixel Pitch (Full/Binning mode)	14.8 / 29.6	14.8 / 29.6	14.8 / 29.6
DQE (6lp/mm, Full/Binning mode)	0.38 / 0.34	0.38 / 0.34	0.38 / 0.34
MTF (3lp/mm, Full/Binning mode)	0.642 / 0.630	0.642 / 0.630	0.642 / 0.630
Typical dose range (Incisor & Canine)	300 ~ 500	300 ~ 500	300 ~ 500
Typical dose range (Molar)	400 ~ 600	400 ~ 600	400 ~ 600
Standards of Conformity	Compliance with relevant IEC/ISO standards	Listed standards achieved	Listed standards achieved
Biocompatibility	Not warranted (no patient contact)	Not warranted (no patient contact), single-use protective barrier used	Not warranted (no patient contact), single-use protective barrier used
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-2	Conforms to standards	Conforms to standards

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/Not specified for a clinical performance test. The "test set" here refers to the physical units subjected to bench testing (e.g., for electrical safety, EMC, SSIX report). The sample size for these engineering tests is not provided in this summary.
- Data Provenance: The tests are "Non-Clinical Performance Data." There is no mention of patient data (images) or their provenance (country of origin, retrospective/prospective) because a clinical study was not presented for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with ground truth established by experts is described, as this is a substantial equivalence submission relying on bench testing and comparison to a predicate, not a de novo clinical performance study for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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. This device is a digital X-ray sensor, not an AI-powered diagnostic aid. Therefore, no MRMC study or assessment of AI assistance to human readers was performed or presented.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware sensor with image acquisition and management software, not an algorithm for autonomous diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. The "ground truth" for the non-clinical tests would be defined by engineering specifications and reference standards (e.g., a calibrated measurement for DQE, MTF).
The sample size for the training set:
- Not applicable. This is a hardware device with associated image processing firmware/software, not a machine learning model that requires a training set in the AI sense.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary of what's provided related to "proving" performance:

The document states "Bench tests were performed and the SSIX Report is shown in this submission. Additional certificates for the device are also within this submission." These tests (e.g., DQE, MTF, electrical safety, EMC) provide objective measurements of the device's physical and technical performance parameters, which are then compared to the predicate device to argue for substantial equivalence. The "proof" here is that these technical specifications are essentially identical to those of the cleared predicate device, and the device conforms to relevant safety and performance standards (IEC, ISO).

In a 510(k), especially for a device like this, the "acceptance criteria" for clearance are primarily:

Same intended use as the predicate.
Same technological characteristics as the predicate OR different technological characteristics that do not raise new questions of safety and effectiveness.
Performance data (bench testing) demonstrating that the device is as safe and effective as the predicate.

This submission explicitly concludes: "The subject and the predicate device have the same intended use and the same technological features. I View Gold and Imagen Gold Sensors and share the same principles of operation, sensor technology, use the same USB connection to PC and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate." The "study" proving this is the collection of non-clinical bench tests and the detailed comparative analysis of technical specifications presented in the submission.

Summary

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April 15, 2020

Trident s.r.l % Joyce St. Germain Regulatory Consultant The 510K Consulting, LLC 1449 Springleaf Drive ORMOND BEACH FL 32174

Re: K200625

Trade/Device Name: I-View Gold and Imagen Gold Dental Sensors Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: March 5, 2020 Received: March 10, 2020

Dear Joyce St. Germain:

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

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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.

For

Thalia T. Mills, Ph.D. Director 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) K200625

Device Name

I-View Gold and Imagen Gold Dental Sensors

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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The 510k Consulting, LLC

1449 Springleaf Dr., Ormond Beach, FL 32174 Key to success in obtaining your medical device clearance Joyce510kfda@gmail.com

510(k) Summary

Submitter/Applicant

Trident s.r.l. Via Artigiani 4 Castenedolo, (BS) Italy 25014

Phone:	+39-0302732485
Fax:	+39-0302731647
Contact:	Giorgio Rizzo, CEO Giorgio.Rizzo33@gmail.com

Consultant/Contact

The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174

Phone: 904-477-3203 Joyce St. Germain, Regulatory Consultant, joyce510kfda@gmail.com Contact:

Device Classification

Trade/Model Names:	I-View Gold and Imagen Gold Dental Sensors
Common Name:	Intraoral Digital X-ray Dental Sensors
Classification Name:	System, X-ray, Extraoral Source, Digital
Regulation Name:	Extraoral Source X-ray System
Regulation Number:	21 CFR 872.1800
Product Code:	MUH
Regulatory Class:	II
510k Review Panel:	Radiology

Predicate Device

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

510(k) Number:	K153060
Date Cleared:	November 10, 2015
Trade Name:	EzSensor Classic; HDI-U10DB and HDI-U20DB

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Common Name:	Intraoral Digital X-ray Dental Sensors
Classification Name:	System, X-ray, Extraoral Source, Digital
Regulation Name:	Extraoral Source X-ray System
Regulation Number:	21 CFR 872.1800
Product Code:	MUH
Regulatory Class:	II
510k Review Panel:	Radiology

The predicate device, K153060, is the identical sensor as the subject and manufactured by Rayence. The devices for this submission have different trade names and different software brand names. The difference in the subject and predicate devices are the software packages; however, their functionality is the same.

Indications for Use

I-View Gold sensors are digital dental intra oral sensors 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.

Intended Use

Radiographic examination to assist with diagnosis of the teeth, jaw, and oral structure.

Device Description

The subject comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm² and two brand names.

Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure.

The primary advantage of direct sensor systems is the speed with which images are acquired.

For patient comfort, the ergonomic design is based on human intraoral anatomy.

· Excellent image quality based on advanced CMOS technology
· More comfortable sensor ergonomic shape for the human oral structure
· Lower dose exposure (Compared to film sensor)
Enhanced durability
Easy-to-use USB interface

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The I-View Gold and Imagen Gold sensors have reference numbers as follows:

I-View Gold - size 1 Ref # ISO14-S I-View Gold – size 2 Ref # ISO15-S Imagen - size 1 Ref # ISO 18-S Imagen - size 2 Ref # ISO19-S

NOTE: Two different trade names are for marketing purposes.

Before Trident sells these devices, their technicians discuss the hardware and software that the dentist has, to make sure that their systems are compatible with the these sensors. Trident offers technical support for these devices to ensure proper operation and to answer any questions regarding the function of the devices. A means to contact Trident is provided to all end users in their user manual.

The type of x-ray systems that integrate with the I-View Gold and Imagen sensors are wall-mounted generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time.

This device and software cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver.

Archimed Suite is a software produced by Digital Imaging and Deep-View is a brand name for Trident. Archimed Suite / Deep-View software was cleared with K160386 and K162619.

I-View Gold sensors use DEEP-VIEW software that is connected by a 'USB A' cable to a compatible Windows XP or Windows Vista or Windows 7 PC. I-VIEW GOLD is provided the power from PC. Support for the I-VIEW GOLD is provided by compatible software programs such as Deep-View.

DEEP-VIEW and ARCHIMED SUITE complies with the European Directive 93/42 EEC (and its revised version) and CE Certification issued by IMO 0051. Italy.

The subject device is intended to be used by dentists, radiologists and other legally qualified professionals.

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Comparison of Technological Characteristics with Predicate

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

Table 5 -- Technological Comparison

	Subject DeviceI-View Gold,Imagen Gold	PredicateDeviceEzSensors(Detailed liston page 1 ofthisdocument)
510(k)	Not assigned yet	K153060(Cleared November 10,2015)	NA
Applicant	Trident s.r.l.,Italy	Rayence, Korea	NA
Manufacturer—Imaging SoftwareComponent	Deep-View brand nameof Archimed Suiteproduced by DigitalImaging	Easy Dent/EzDent-IRayence	by Difference
Classification;Product Code	872.1800; MUH	872.1800; MUH	None
Common name	Intraoral Digital X-Ray Sensor	Intraoral Digital X-RaySensor	None
Indications for Use	I-View Gold (andImagen Gold)sensors are digitaldental intra oralsensors intended tocollect dental x-rayphotons and convertthem into electronicimpulses that maybe stored, viewed,and manipulated for	Digital Dental IntraOral Sensor is intendedto collect dental x-rayphotons and convertthem into electronicimpulses that may bestored, viewed andmanipulated fordiagnostic use bydentists.	None
	diagnostic use bydentists.
Intended use	Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw and oral structure.	Radiographicexamination to assistwith diagnosis ofdiseases of the teeth, jawand oral structure.	None
Principles of operation	X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital) =>electronics => PC(capture & displayimage)	X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital) =>electronics => PC(capture & displayimage)	None
Sensor Dimensions (mm)	Size 1.0: 36.8 x 25.4Size 2.0: 42.9 x 31.3	Size 1.0: 36.8 x 25.4Size 1.5: 39.5 x 29.2Size 2.0: 42.9 x 31.3	Difference(Predicate has aadditional sizesensor)
Sensor Thickness (mm)	4.8	4.8	None
Active Area (mm)	Size 1.0: 30.01 x 20.01Size 2.0: 35.99 x 25.99	Size 1.0: 30.01 x 20.01Size 1.5: 33.00 x 23.98Size 2.0: 35.99 x 25.99	Difference(Predicate has aadditional sizesensor)
USB Module	Integrated USB 2.0module	Integrated USB 2.0module	None
Pixel PitchFull resolution /Binning mode	14.8 / 29.6	14.8 / 29.6	None
DQE (6lp/mm)Full resolution /Binning mode	0.38 / 0.34	0.38 / 0.34	None
MTF (3lp/mm)Full resolution /Binning mode	0.642 / 0.630	0.642 / 0.630	None
Typical dose range	Incisor & Canine:300 ~ 500 / Molar:400~ 600	Incisor & Canine:300 ~ 500 / Molar:400~ 600	None
Standards ofConformity	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-65IEC 62336EN 62304IEC 60529ISO 15223-1ISO 14971	IEC 60601-1IEC 60601-1-2	Both devicespassed standardsperformed

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Guidance Documents

This petition was prepared in conformance with the following FDA guidance instructions and documents:

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014

Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.

Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016

Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Document issued on: May 11, 2005 Medical Devices, Document issued on: May 11, 2005

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Non-Clinical Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility... Biocompatible testing for the subject is not warranted because there are no direct or indirect patient-contacting components in the subject device. It is covered with a single-use protective barrier prior to each use just like the Ravence predicate device.

Electrical Safety and EMC... The device does require EMC and Electrical Safetv evaluation. EMC and electrical safety testing data reports for the subject device are provided in this petition.

· The I View and Imagen Sensors conforms to electrical and safety standard IEC 60601-1 (Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance).

· The I View and Imagen Sensor conforms to electrical and safety standard IEC 60601-1-2 (Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential 3271 performance - collateral standard: Electromagnetic compatibility).

Software ... The device does contain software/firmware. I-View Gold and Imagen Sensor electronics contains firmware along with a driver and both use image management software provided by Digital Imaging, Italy; therefore, only firmware and driver documentation for the subject device are included in this petition.

Performance Testing ... Bench tests were performed and the SSIX Report is shown in this submission. Additional certificates for the device are also within this submission.

Conclusion

The subject and the predicate device have the same intended use and the same technological features. I View Gold and Imagen Gold Sensors and share the same principles of operation, sensor technology, use the same USB connection to PC and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate. As previously stated, these devices are identical in structure and use. The sensors will only have different brand names for marketing purposes.

Again, K150823 and K151926 are identical to the subject sensors I View Gold and Imagen Gold Sensor. The software packages of the subject device and the predicate are different. The subject device software, Deep-View has been FDA cleared with other similar devices. Additional information regarding Deep-View is stated throughout the submission.

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The I-View Gold and Imagen Gold Sensors warrants a finding of substantial equivalence to both the legally marketed EzSensor Classic Series and thus clearance for premarket activities in the United States.

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.