Intra Oral Sensor (model: IOX 1 / IOX 2) is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.

Device Description

Intraoral Sensor (model: IOX 1 / IOX 2) by Dentium is a medical device that acquires digital images by detecting subject information through X-rays and converting them into electrical image signals to identify teeth and tissues in the mouth. The product consists of the Intraoral Sensor, USB Memory, Sensor Holder, Silicon Cover and Quick Guide.

AI/ML Overview

The provided text describes information related to a 510(k) submission for an Intra Oral Sensor (model: IOX 1 / IOX 2) by Dentium Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and adherence to relevant standards.

Here's an attempt to extract the requested information, noting that some details typically found in a full study report (e.g., specific sample sizes for test sets, detailed ground truth establishment for training) are not fully elaborated in this summary document.

Acceptance Criteria and Device Performance:

The document states that "Performance testing was conducted for the subject device to assess whether or not the parameter required for functionalities related to imaging properties of the dental X-ray device meets the designated acceptance criteria. All test results were satisfactory." And specifically mentions: "The tests include the MTF(Modulation Transfer Function) and DOE(Detective Quantum Efficiency) of detector. MTF of detector shows the resolution more than 30 % at 6 lp/mm and The DQE of detector shows the resolution more than 40 % at 2.5 lp/mm."

Based on the information provided, the following table can be constructed:

Acceptance Criteria (Imaging Performance)	Reported Device Performance (Intra Oral Sensor IOX 1 / IOX 2)
MTF: More than 30% at 6 lp/mm	MTF: More than 30% at 6 lp/mm (Satisfactory)
DQE: More than 40% at 2.5 lp/mm	DQE: More than 40% at 2.5 lp/mm (Satisfactory)

Study Details:

Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): The document does not specify the exact number of images or cases used in the performance bench testing. It refers to "bench testing" and "performance (imaging performance) testing" according to standard IEC 61223-3-4.
- Data Provenance: This was a non-clinical bench study focused on the technical performance of the device itself (sensor characteristics), not on clinical images from patients. Therefore, data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Since this was a non-clinical bench test of technical performance (MTF, DQE), there were no human experts involved in establishing "ground truth" for diagnostic purposes. The ground truth was based on physical measurements of the sensor's technical specifications as per established engineering standards (e.g., IEC 61223-3-4 for imaging performance).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this was a non-clinical bench test, there was no adjudication process involving human reviewers.
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, an MRMC comparative effectiveness study was not done. This submission is for an intraoral sensor, which is a hardware device for capturing X-ray images, not an AI-powered diagnostic software. The study focused on the technical performance equivalence of the sensor to its predicate device. Clinical data and comparative effectiveness studies involving human readers or AI assistance were explicitly stated as "Not required for a finding of substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable as this is a hardware device. This submission is for an intraoral sensor, which is a hardware device that acquires images. There is no standalone algorithm being evaluated for diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this study was based on physical and engineering measurements of the sensor's imaging performance characteristics (MTF, DQE) according to established international standards (IEC 61223-3-4). It is a technical ground truth, not a clinical one.
The sample size for the training set:
- Not applicable. This device is a hardware sensor, not an AI algorithm that requires a training set for machine learning.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm.

Summary of what the document implies about the study:

The study conducted was a non-clinical bench performance study designed to demonstrate that the new Intra Oral Sensor (IOX 1 / IOX 2) meets technical imaging performance specifications (MTF and DQE) that are substantially equivalent to its predicate device. This type of study focuses on the physical properties and output quality of the imaging hardware itself, rather than evaluating diagnostic accuracy with human readers or AI algorithms on clinical cases. The ground truth was based on objective physical measurements and engineering standards.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 10, 2020

Dentium Co., Ltd (ICT Branch) % Dave Kim Medical Device Regulatory Affairs Mtech Group 7707 Fannin St. Ste 200, V111 HOUSTON TX 77054

Re: K201247

Trade/Device Name: Intra Oral Sensor (model: IOX 1/ IOX 2) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, MUH Dated: May 4, 2020 Received: May 11, 2020

Dear Dave 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. 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

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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 (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,

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) K201247

Device Name Intra Oral Sensor (model: IOX 1 / IOX 2)

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 K201247

The summary of 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Date:	6/8/2020
APPLICANT	Dentium Co.,Ltd (ICT Branch)
ADDRESS	76, Changnyong-daero 256beon-gil, Yeongtong-guSuwon-si, Gyeonggi-do, 16229Republic of Korea++82-70-7098-6932
Contact Person	Mr. Sang Woo Lee (swlee1@dentium.com)
OfficialCorrespondent	Dave Kim, MBAMtech Group7707 Fannin St. Ste 200, Houston, TX 77054TEL : 713-467-2607Email : davekim@mtech-inc.net

Device Name

Trade Name:	Intra Oral Sensor
Model Name:	IOX1 / IOX2
Regulation Name:	Stationary X-ray System
Regulatory Number:	21 CFR 892.1680
Regulatory Class:	II
Product code:	MQB, MUH
Panel:	Radiology

Predicate device

Predicate device (K143000)
Trade/Device Name:	RIO Sensor (RIS 500)
Regulation Number:	21 CFR 892.1680
Regulation Name:	Stationary x-ray system
Regulatory Class:	II
Product Code:	MQB
Reference Device (K090526)
ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ
Trade/Device Name:	EzSensor
Regulation Number:	21 CFR 872.1800
Regulation Name:	Extraoral source X-ray system
Regulatory Class:	II
Product Code:	MUH

Dentium Co.,Ltd

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Descrintion

Indication for use

Parameter	Proposed Device	Predicated Device	Reference Device
Manufacturer	DENTIUM Co., Ltd	RAY Co., Ltd	E-WOO Technology Co., Ltd.
DeviceName	Intra Oral SensorIOX1 / IOX2	RIS500	EzSensor
510(K)Number	K201247	K143000	K090526
Feature	Image: Proposed Device Feature	Image: Predicated Device Feature	Image: Reference Device Feature
Indicationsfor use	Intra Oral Sensor (model: IOX 1 /IOX 2) is intended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, views andmanipulated for diagnostic use bydentists.	This system is intended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, views andmanipulated for diagnostic use bydentists.	Indicated for intended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, viewed, andmanipulated for diagnostic use bydentist.
DeviceDescription	Intra Oral Sensor (model: IOX 1 /IOX 2) is a medical device thatacquires digital images bydetecting subject informationthrough X-rays and convertingthem into electrical image signalsto identify teeth andtissues in the mouth. The productconsists of the Intraoral Sensor,USB Memory, Sensor Holder,Silicon Cover and Quick Guide	RIOSensor(Model RIS500) isintended to acquire real-time,clinical digital intraoral X-rayimages using a solid-stateimaging sensor. This systemconsists of the CMOS sensor andsoftware for image display. Thissystem senses the onset of the X-ray exposure and automaticallyacquires and save the image datato a PC (software).	The EzSensor is a solid state x-ray imager designed for dentalradiographic applications, TheEzSensor provides digital imagecapture for conventionalfilm/screen radiographic dentalexaminations. The device is usedto replace radiographicfilm/screen system in generaldental diagnostic procedures. Thecaptured digitalimage is transferred to PersonalComputer via USB interface port
SensorDimension	IOX 1: 36.7 x 24 mmIOX 2: 42.6 x 29.1 mm	Size 1: 39x25 mmSize 2: 42x30 mm	Size "1.0": 35.7x25.2 mm Size"1.5": 38.7x29.2 mm
SensorThickness	5.1 mm	5.6 mm	4.95mm
ActiveArea(mm)	IOX 1: 20 x 30 mmIOX 2: 26 x 36 mm	Size 1: 39x25Size 2: 42x30	Size "1.0": 20.02x30.03Size "1.5": 24.08x31.85
USBModule	Integrated USB 2.0 module	Integrated USB 2.0 module	Integrated USB 2.0 module
Pixel size	20x20 μm	20x20 μm	35x35 μm
Pixel Matrix	IOX 1: 1000x1500 pixel IOX 2:1280x1801 pixel	Size 1: 1000x1500 pixel Size 2:1300x1700 pixel	Size "1.0": 572x858 pixel Size"1.5": 686x944 pixel
Pixel Pitch	20x20 μm	20x20 μm	35x35 μm
TheoreticalResolution	25 lp/mm	25 lp/mm	14.3 lp/mm
MTF	More than 30 % at 6 lp/mm	More than 30% at 6 lp/mm	More than 30% at 6 lp/mm
DQE	More than 40 % at 2.5 lp/mm	More than 40% at 2.5 lp/mm	More than 40% at 2.5 lp/mm

Statement of Substantial Equivalence

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The intended use, constructions, construction materials, technical characteristics and safety characteristics between Intra Oral Sensor (model: IOX 1 / IOX 2) and its predicate device are same.

The differences include the digital X-ray imager sizes and image viewing software. Performance testing was conducted for the subject device to access whether or not the parameter required for functionalities related to imaging properties of the dental X-ray device meets the designated acceptance criteria. All test results were satisfactory.

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Safetv and Effectiveness Information:

Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1(2005+ CORR.1(2006)+CORR.2(2007), AMD 1: 2012 was performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2(2014).

The software of Intra Oral Sensor (model: IOX 1 / IOX 2) has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the guidance document.

Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench"

Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.

Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory.

Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".

All test results were satisfactory.

The tests include the MTF(Modulation Transfer Function) and DOE(Detective Quantum Efficiency) of detector. MTF of detector shows the resolution more than 30 % at 6 lp/mm and The DQE of detector shows the resolution more than 40 % at 2.5 lp/mm.

Base on the Non-Clinical Test report, Even though the pixel size and active area of predicate detectors are different, the diagnostic image quality of Intra Oral Sensor (model: IOX 1 / IOX 2) is substantially equivalent to that of predicate device and there is no significant difference in efficiency and safety.

Clinical Data: Not required for a finding of substantial equivalence.

Conclusions

In accordance with the federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Dentium Co., Ltd concludes that the Intra Oral Sensor (model: IOX 1 / IOX 2) present no new risk and perform its intended use substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.