Digital Dental Intra Oral Sensor is 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

Digital Dental Intra Oral Sensor is a device which acquires digital intra-oral images. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Digital Dental Intra Oral Sensor, EzSensor Smart" device, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive standalone performance study with detailed acceptance criteria and ground truth validation as one might find for a novel AI device. Therefore, some information, particularly regarding specific numerical acceptance criteria and a detailed multi-reader multi-case (MRMC) study, is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a pass/fail format for diagnostic performance. Instead, it focuses on demonstrating superiority or substantial equivalence to a predicate device (EzSensor) through various technical characteristics and a comparative image review.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Proposed Device)
Diagnostic Image Quality	Produce images allowing for correct diagnosis of a range of anatomic structures while minimizing radiation exposure to patients. Ideally, equivalent or superior to the predicate device.	Images produced by the proposed device (IOS-U15VF AND 11MODELS, both Binning Mode and Full Resolution Mode) were consistently better than the predicate device (EzSensor) in terms of diagnostic quality in most cases. Negligible difference between Binning Mode and Full Resolution Mode. All images from both devices presented no significant difficulty in evaluating a range of anatomic structures necessary for a correct diagnosis.
Pixel Pitch ($\mu$m)	Improved (smaller) pixel pitch compared to predicate for better resolution.	Full Resolution: 14.8 $\mu$m; Binning mode: 29.6 $\mu$m (Predicate: 35 $\mu$m)
DQE (6 lp/mm)	Improved DQE compared to predicate for better dose efficiency.	Full Resolution: 0.38; Binning mode: 0.34 (Predicate: 0.123) - Consistently performed better.
MTF (6 lp/mm)	Improved MTF compared to predicate for better resolution.	Full Resolution: 0.642; Binning mode: 0.630 (Predicate: 0.382) - Consistently performed better.
Linear Response to X-ray Exposure	Improved linearity (closer to 1) compared to predicate.	Very linear response, closer to 1, than the predicate device in the same dynamic range.
Electrical, Mechanical, Environmental Safety	Compliance with IEC/EN 60601-1 and IEC 60601-1-2 EMC standards.	Electrical, mechanical, environmental safety and performance testing according to IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) and EMC testing according to IEC 60601-1-2:2007 were performed. (Implied compliance, as the conclusion states the device is safe and effective).
Risk Mitigation	All identified risks successfully mitigated and accepted.	Risks analyzed with FMEA method; specific risk control measures implemented. Overall assessment concluded all risks from design change successfully mitigated and accepted.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "Total 30 sets of radiographic image samples" were reviewed for diagnostic image quality.
Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but given it's an evaluation of image samples, it's most likely retrospective image data captured using the devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: "a licensed dentist." (Singular)
Qualifications: "licensed dentist." (No specific years of experience or subspecialty beyond general dentistry is mentioned).

4. Adjudication Method for the Test Set

Adjudication Method: "Based on the reviewer's conclusion..." The use of a single licensed dentist for review indicates none in terms of formal adjudication (e.g., 2+1 or 3+1 consensus). The assessment relies on a single expert opinion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, a formal MRMC comparative effectiveness study was not done. The evaluation of diagnostic image quality was conducted by a single licensed dentist reviewing 30 image sets.
Effect Size: Not applicable, as no MRMC study was performed. The comparison was qualitative by a single reviewer ("superior to EzSensor in terms of diagnostic quality in most cases").

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This device is a digital intra-oral sensor, a hardware device that captures X-ray images, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The performance tests described relate to the sensor's physical and technical image acquisition capabilities (e.g., DQE, MTF, pixel pitch) and how the images are perceived by a human reader.

7. The Type of Ground Truth Used

Type of Ground Truth: For the diagnostic image quality assessment, the ground truth was expert opinion/consensus by a single "licensed dentist." It's an assessment of whether the images facilitate correct diagnosis, rather than being linked to independent pathology or patient outcomes data.
For technical characteristics (pixel pitch, DQE, MTF, linearity), the "ground truth" is derived from laboratory measurements using standardized testing methods.

8. The Sample Size for the Training Set

The document describes a hardware device (intra-oral sensor) and its associated viewing software. It does not mention any machine learning or AI components that would require a "training set." Therefore, this question is not applicable to this device submission.

9. How the Ground Truth for the Training Set was Established

As there is no mention of a training set for an AI algorithm, this question is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ravence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K150797

Trade/Device Name: Digital Dental Intra Oral Sensor, EzSensor Smart: IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOS-U10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 24, 2015 Received: April 29, 2015

Dear Mr. Kim:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150797

Device Name

EzSensor Smart

Digital Dental Intra Oral Sensor IOS-U15VF, IOS-U1 OVF, IOS-U1 OI, IOS-U15VB, IOS-U10VB, IOS-U10VB, IOS-U151B, IOS-U1 OIB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U1 ODF

Indications for Use (Describe)

Digital Dental Intra Oral Sensor is 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.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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1. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510K summary prepared: March 25, 2015

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	Rayence Co., Ltd.
Submitter's Address:	14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea
Submitter's Telephone:	+82-31-8015-6459
Contact person:	Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
(U.S. Designated agent)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/proprietary name:	IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB,
	IOS-U10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB,
	HDI-U15DF, HDI-U10DF
Common Name:	EzSensor Smart, Digital Dental Intra Oral Sensor
Regulatoin number:	21 CFR 872.1800
Classification Name :	Extraoral source X-ray system
Product Code:	MUH

Predicate Device :

Manufacturer	: Rayence Co., Ltd.
Device	: EzSensor
510(k) Number	: K090526
The Regulation Number	:21 CFR 872.1800
	1

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Classification Name : Extraorla Source X-rav System Primary Product Code : MUH

2. Device Description

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

3. Indication for use

Digital Dental Intra Oral Sensor is 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.

4. Summary of Design Control Risk management

The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.

5. Summarv of the technological characteristics of the device compared to the predicate device

Digital Dental Intra Oral Sensor described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, EzSensor of Rayence Co., Ltd.

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5.1 Feature
Image /page/5/Figure/2 description: The image shows two diagrams of a device labeled as 'Proposed: IOS-U15VF AND 11MODELS' and 'Predicate: EzSensor'. Both diagrams depict a device with three main components labeled A, B, and C. Component A is identified as a USB Connector, component B is an Interface Board, and component C is a Sensor Head.

Mechanical design change point

	Proposed	Predicate
A	1) Ensure robustness by using the stainless steel material to theinside of the frame.2) Soft silicone material surrounds the USB Connector toreduce the protected from a potential external impact when itis positioned behind the PC.	No stainless steel frameNo silicon materialprotecting USB connector
B	1) Easy-to-use USB Interface with the interface board alreadyintegrated with the A.	The interface board requiresa separate USB cable toconnect to PC
C	1) structure is similar2) Improved waterproofing structure(prevents moisture permeation of external environment).	-

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510(k) Submission - IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOU10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF

The potential risks of IOS-U15VF AND 11 MODELS such as electroic shock, device failure, misdiagnosis, tissue damage, serious leakage current, etc... were analyzed by conducting complete verification for IEC/EN 60601-1 and drop & vibration test. (Completed the risk analysis for A,C above).

While applying the stainless steel material to the inside of the frame, soft silicon material surrounds the exterior of the USB connector to reduce the protected from a potential external impact. Additional risk analysis was conducted to mitigate the potential risks that may arise with respect to leakage current, sensor fracture or breakage, and cable disconnection. The risk mitigation measures were satisfactory to manage the new risks identified and the residual risks were within acceptable limits.

Characteristic	ProposedRayence Co., Ltd.IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF,IOS-U15VB, IOS-U10VB, IOS-U15IB, IOS-U10IB,HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF	PredicateRayence Co., Ltd.EzSensor
Feature	Image: Proposed Rayence Co., Ltd.	Image: Predicate Rayence Co., Ltd. EzSensor
510(k) number	-	K090526
Indicationsfor use	Intra-Oral Sensor is intended tocollect dental x-ray photons andconvert them into electronic impulsesthat may be stored, viewed andmanipulated for diagnostic use bydentists.	EzSensor, an Intra-oral ImagingSystem, is intended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, viewed, andmanipulated for diagnostic use bydentists.
SensorDimension(mm)	Size 1.0: 37.6 x 25.4Size 1.5: 39.5 x 29.2	Size 1.0: 35.7 x 25.2Size 1.5: 38.7 x 29.2
SensorThickness(mm)	4.8	4.9
Active PixelArea(mm)	Size 1.0: 1352 x 2028 pixels(20.00 x 30.01 mm)676 x1014 pixels@Binning ModeSize 1.5: 1620 x 2230 pixels(23.98 x 33.00 mm)810 x 1115 pixels@Binning Mode	Size 1.0: 20.02 x 30.03Size 1.5: 24.08 x 31.85

5. 2 Characteristic

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510(k) Submission – IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOU10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF

USB Module	Integrated USB 2.0 module		Integrated USB 2.0 module
Pixel Pitch( $\mu$ m)	Full Resolution	14.8	35
	Binning mode	29.6
DQE(6 lp/mm)	Full Resolution	0.38	0.123
	Binning mode	0.34
MTF(6 lp/mm)	Full Resolution	0.642	0.382
	Binning mode	0.630
Typical doserange( $\mu$ Gy)	Incisor & Canine : 300 ~ 500 $\mu$ Gy / Molar: 400 ~ 600 $\mu$ Gy
Viewer Software	EasydentDental Imaging ViewerEzDent i (K131594)		Easydent

5. 3 Viewer Software

Characteristic	ProposedRayence Co., Ltd.IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF,IOS-U15VB, IOS-U10VB, IOS-U15IB, IOS-U10IB,HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF	PredicateRayence Co., Ltd.EzSensor
Viewer Software	Easydent (Same viewer software usedfor EzSensor Soft, K143753)Dental Imaging ViewerEzDent i (K131594)	Easydent

With the identical hardware configuration, the subject device has different model names distinguished by the sensor size and type of image viewing software utilized. The software functions include the patient information management, image capture, and an image viewer.

Easydent/Dental Imaging Viewer and EzDent i image viewing software have the same functionality and performance. The main difference is the design of the user interface (UI) and new consulting simulation tool for EzDent i. EzDent i requires a license registration for a fee whereas Easydent/ Dental Imaging Viewer is provided free of charge.

Viewer Software	510(k) Number	Manufacturer	Comment
Easydent	Same viewersoftware usedfor EzSensorSoft, K143753	Rayence Co., Ltd.	Easydent and Dental ImagingViewer is same Software. Differenceis that CI is displayed on the UI formarketing purposes.
Dental Imaging Viewer	-	Rayence Co., Ltd.	-
EzDent i	K131594	EWOO SOFT	-

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	Easydent	EzDent i
	Dental Imaging Viewer
Function	PatientViewAcquisitionConsultationReport	PatientViewAcquisitionConsultationReportLicense
The initialscreen shot	Image: Easydent initial screen shot	Image: EzDent i initial screen shot
ImageAcquisitionscreen	Image: Easydent acquisition screen	Image: EzDent i acquisition screen

1) Difference for Easydent/Dental Imaging Viewer and EzDent i

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1. Features added to EzDent i

2.2.1. Acquisition CONSULT Tab

Acquisition CONSULT Tab is a consulting tool and provides a video simulation of the treatment process with the acquired images in sequence.

Image /page/9/Picture/4 description: The image shows a screenshot of a dental imaging software interface. On the left, there is a search panel with options like 'Favorites' and categories such as 'Bridge' and 'Crown'. The central part of the screen displays a dental X-ray image, while the right side features a diagram of a tooth and a video player with thumbnails labeled 'CONSULT CONTENTS THUMBNAIL'.

2.2.2. License

EzDent i requires a fee based license registration whereas EasyDent is provided free of charge.

6. Summary of Performance Testing

The IOS-U15VF AND 11MODELS are the modification of EZSensor. FDA cleared predicate device under the document number K090526 and the performance of both subject and predicate devices are substantially equivalent in terms of safety and effectiveness.

The intended use, application and detector type for both IOS-U15VF AND 11MODELS and the predicate device are identical. Both IOS-U15VF AND 11MODELS and EzSensor use the same amorphous silicon alley and materials for fluorescent as the sensing means. The performance test results indicate that the IOS-U15VF AND 11MODELS detector performed consistently better than EzSensor,the predicated device, in terms of image quality. No additional safety risk is identified in the bench test: Non-clinical report.

With a smaller measured pixel size of IOS-U15VF AND 11MODELS, both in full resolution and in 2x2 binning mode, DQE, MTF, and linear response to X-ray exposure test demonstrated that IOS-U15VF AND 11MODELS has consistently performed better than EzSensor, the predicate sensor. Especially, the response of IOS-U15VF AND 11MODELS as a function of X-ray exposure is very linear and has better linearity, close to 1, than EzSensor in the same dynamic range.

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510(k) Submission - IOS-U15VF, IOS-U10VF, IOS-U15IF, IOS-U10IF, IOS-U15VB, IOU10VB, IOS-U15IB, IOS-U10IB, HDI-U15DB, HDI-U10DB, HDI-U15DF, HDI-U10DF

Total 30 sets of radiographic image samples were reviewed by a licensed dentist. Based on the reviewer's conclusion, IOS-U15VF AND 11MODELS (Binning Mode and Full Resolution Mode) produce images which are superior EzSensor in terms of diagnostic quality in most cases. There is negligible difference between Binning Mode and Full Resolution Mode. All images from both devices present no significant difficulty in evaluating a range of anatomic structures necessary to provide a correct diagnosis while minimizing radiation exposure to patients.

These images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the subject devices operate as indicated.

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.

7. 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. Rayence Co., Ltd. concludes that IOS-U15VF AND 11MODELS is safe and effective and substantially equivalent to predicate device as described herein.

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.