HDI 2000 / HDI 2000A, an Intra-Oral 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 HDI 2000 / HDI 2000A Intra-oral imaging system is a device which acquires digital image. Direct digital systems acquire images with a solid-state 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. The sensor is connected by a wire to an analog-to-digital USB box, which is connected to the computer. Images are produced within seconds of sensor exposure. The wire length from a direct sensor is about 3 meters and less. The USB box connects to the USB 2.0 port of the computer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HDI 2000 / HDI 2000A device:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (EzSensor P) rather than presenting a de novo clinical study with explicit acceptance criteria for diagnostic performance. Therefore, many of the typical clinical study details are not present.

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission for substantial equivalence based on technological characteristics, explicit numerical diagnostic performance acceptance criteria (e.g., sensitivity, specificity, AUC) are not defined or reported for diagnostic accuracy. The acceptance criteria revolve around meeting established safety and performance standards for medical electrical equipment and X-ray imaging devices, and demonstrating that the new device does not raise new questions of safety or effectiveness compared to the predicate.

Acceptance Criteria Category	Specific Standard/Guidance	Reported Device Performance / Compliance
Electrical, Mechanical, Environmental Safety & Performance	IEC 60601-1:2005 + CORR.I(2006) + CORR(2007)	"All test results were satisfactory."
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2007	"EMC testing were conducted in accordance with standard IEC 60601-1-2:2007."
Non-clinical & Clinical Considerations for Solid State X-ray Imaging Devices	FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices	"Non-clinical & Clinical considerations... was performed."
Technological Equivalence (Primary justification)	Comparison to predicate device (EzSensor P)	"The indications for use, material, form factor, performance, and safety characteristics of HDI 2000 / HDI 2000A described in this 510(k) are the same as that of the predicate device... The difference in the physical dimension of the sensor does not present any new concerns in terms of safety and effectiveness."
Software Risk Analysis	Not explicitly stated, but implied by "design control risk analysis for ProraView"	"All risks are mitigated and any residual risks are determined acceptable."

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

The document does not describe a clinical test set in the traditional sense of a clinical trial for diagnostic performance. The testing described is primarily for engineering standards compliance (safety, EMC) and performance characteristics relevant to sensor operation, rather than a clinical evaluation of diagnostic accuracy using a test dataset of patient images.

Sample Size for Test Set: Not applicable in the context of diagnostic performance. The document refers to "test results" for electrical, mechanical, environmental, and EMC testing, which would involve laboratory testing of device units.
Data Provenance: Not applicable for diagnostic performance as no clinical diagnostic test set is described. The engineering tests would be performed in a controlled laboratory environment.

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

Not applicable. As no clinical test set for diagnostic performance is described, there's no mention of experts establishing a ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process for diagnostic interpretations is described.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) submission. The submission focuses on demonstrating substantial equivalence based on technological characteristics and engineering tests, not a clinical comparison of diagnostic efficacy.

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

This device is an intra-oral imaging system (sensor and software), not an AI algorithm designed to interpret images independently. Therefore, the concept of "standalone performance" for an AI algorithm without human-in-the-loop is not applicable to this submission. The device's function is to acquire and display images for diagnostic use by dentists.

7. The Type of Ground Truth Used

The concept of "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data) is not applicable in this submission, as no diagnostic performance study is described. The "truth" being evaluated relates to the device's adherence to engineering standards and its functional performance as an imaging system (e.g., image capture, viewing) being equivalent to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is an imaging sensor and viewer software; it is not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a "training set" of data for learning diagnostic patterns.

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

Not applicable, as there is no training set for an AI/ML algorithm described.

Summary

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K140060
Page 1 of 4

510(k) Submission – HDI 2000 / HDI 2000A

510(k) Summary

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

Date 510K summary prepared: January 3, 2014

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 / 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:	HDI 2000, HDI 2000A
Common Name:	Medical Image Processing Unit
Classification Name :	21CFR892.1680 / Stationary x-ray system
Product Code:	MQB

Predicate Device :

Manufacturer	: Rayence Co., Ltd.
Device	: EzSensor P
510(k) Number	: K121132 (Decision Date - MAY. 10. 2012)

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Device Description :

Indication for use :

HDI 2000 / HDI 2000A, an Intra-oral Imaging System, 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.

Summary of the technological characteristics of the device compared to the predicate device

The The indications for use, material, form factor, performance, and safety characteristics of HDI 2000 / HDI 2000A described in this 510(k) are the same as that of the predicate device, EzSensor P of Rayence Co., Ltd.

The primary difference is the size of new sensors and availability of optional image viewing software, Prora view, which is alreay cleared by FDA (K131594). As demonstrated by the technical comparison between the subject and predicate device, the difference in the physical dimension of the sensor does not present any new concerns in terms of safety and effectiveness.

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1. HDI 2000 / HDI 2000A Summary

1.1 Hardware

The hardware of HDI 2000 and HDI 2000A are identical.

The shape of the top cover and case of EzSensor P ( K121132) are modified without affecting the sensor performance.

Change	HDI 2000 / HDI 2000A	EzSensor P
Image: Sensor ASS'Y	Image: HDI 2000 / HDI 2000A exploded view	Image: EzSensor P exploded view
Sensor_ASS'Y③ : Upper Case⑤ : Top Cover

1.2 Viewer Software

This device is operated using viewer software. With the identical hardware configuration, the model name is distinguished by the type of image viewing software available. The software functions include the patient information management, image capture, and viewer for captured images.

Model	Sensor Type	Size (mm)	Viewer Software	Viewer SoftwareManufacturer
HDI 2000	1.5	38.7 x 29.2 x 4.95	Easydent	Rayence Co., Ltd.
HDI 2000A	1.5	38.7 x 29.2 x 4.95	ProraView (K131594)	EWOO Soft
HDI 2000	2.0	42.8 x 31.5 x 4.95	Easydent	Rayence Co., Ltd.
HDI 2000A	2.0	42.8 x 31.5 x 4.95	ProraView (K131594)	EWOO Soft

Easydent is the same software used for the predicate device whereas ProraView image viewing software is a stand alone imaging viewer program with 510(k) clearance of its own. Both viewing programs have the similar functionality and performance. The main difference is the design of the user interface (UJ) and new consulting simulation tool for Prora View. Prora View requires a fee based license registration for the right to use whereas EasyDent is provided to users free of charge.

The design control risk analysis for ProraView describes hazards associated with respect to SRS and SDS. All risks are mitigated and any residual risks are determined acceptable.

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K140060
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2.1) Difference for Easydent and ProraView

	Easydent	Prora View
Function	Patient	Patient
	View	View
	Acquisition	Acquisition
	Consultation	Consultation
	Report	Report
		License

Summary for any testing in the submission

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005 + CORR.I(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.

Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed.

All test results were satisfactory.

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. Rayence Co., Ltd. concludes that HDI 2000 / HDI 2000A is safe and effective and substantially equivalent to predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element encircles the symbol and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The symbol is a stylized representation of a human figure, with three overlapping figures in a dynamic, forward-leaning pose.

Public Health Service

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

May 13, 2014

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

Re: K140060

Trade/Device Name: Digital Dental Intra Oral Sensor (HDI 2000, HDI 2000A) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and MUH Dated: April 15, 2014 Received: April 18, 2014

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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Page 2—Mr. Kim

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K140060

Device Name

HDI 2000, HDI 2000A digital dental image processing system

Indications for Use (Describe)

HDI 2000 / HDI 2000A, an Intra-Oral 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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 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)

($m, 3)

FORM FDA 3881 (6/13)

PSL" Pakkatung Services { 101 \ 44 -47 \u

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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.