EzSensor P, 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.

Device Description

The EzSensor P digital intra oral sensor is a solid state x-ray imager designed for dental radiographic applications. The EzSensor P digital intra oral sensor provides digital diagnostic image capture to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB interface port.

AI/ML Overview

The acceptance criteria and the study proving the EzSensor P device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain specific acceptance criteria with numerical targets. Instead, it claims substantial equivalence to a predicate device, EzSensor T, by comparing technical characteristics. Performance is implicitly evaluated by demonstrating these characteristics are either the same or superior.

Characteristic	Acceptance Criteria (Implied)	Reported EzSensor P Performance
Indication for Use	Same as predicate device (EzSensor T)	EzSensor P, 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. (Identical to predicate)
Device Description	Same as predicate device (EzSensor T)	EzSensor P is a solid state x-ray imager designed for dental radiographic applications. The EzSensor P digital intra oral sensor provides digital image capture to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port. (Similar to predicate)
Sensor Dimension (mm) Size "1.5"	Within acceptable range, compared to predicate (EzSensor T)	38.7 x 29.2 (Identical to predicate)
Sensor Dimension (mm) Size "2.0"	Within acceptable range, compared to predicate (EzSensor T)	42.8 x 31.5 (Identical to predicate)
Sensor Thickness	Same as predicate device (EzSensor T)	4.95 (Identical to predicate)
Active Area (mm) Size "1.5"	Within acceptable range, compared to predicate (EzSensor T)	24.01 x 33.04 (Identical to predicate)
Active Area (mm) Size "2.0"	Within acceptable range, compared to predicate (EzSensor T)	26.04 x 36.05 (Identical to predicate)
USB Module	Same as predicate device (EzSensor T)	Integrated USB 2.0 module (Identical to predicate)
Pixel Size (µm)	Equal to or improved over predicate device	20x20 (Improved compared to 35x35 of predicate)
Pixel Matrix Size "1.5"	Equal to or improved over predicate device	1200x1650 pixel (Improved compared to 686x944 of predicate)
Pixel Matrix Size "2.0"	Equal to or improved over predicate device	1300x1800 pixel (Improved compared to 744x1030 of predicate)
Pixel Pitch (Spacing)	Equal to or improved over predicate device	0.02 mm x 0.02 mm (Improved compared to 0.035 mm x 0.035 mm of predicate)
Theoretical Resolution	Equal to or improved over predicate device	25 lp/mm (Improved compared to 14.1 lp/mm of predicate)
Scintillator materials	Acceptable as a design difference that does not alter fundamental scientific technology or safety/effectiveness (Implied)	Cesium iodide (CsI) (Different from GOS(Gd2O2S:Tb) of predicate, but deemed substantially equivalent)
Safety and EMC	Compliance with relevant standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2)	Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-1(2nd edition, 2000) for use with IEC60601-1(Al+A2, 1995) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007. All test results were satisfactory.
Non-clinical & Clinical Considerations	Compliance with FDA Guidance for Solid State X-ray Imaging Devices submissions	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.

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

The provided text does not specify a sample size for a test set for evaluating the imaging performance of the EzSensor P directly through clinical or non-clinical image analysis against a ground truth.

The "Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed, and "All test results were satisfactory." However, details on the specific nature of these "clinical considerations," the data provenance (e.g., country of origin, retrospective or prospective), or the number of images/cases used are not provided. The study primarily relies on a comparison of technical specifications to a predicate device.

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

This information is not provided in the document. As detailed above, a specific test set requiring expert ground truth establishment for a diagnostic performance study is not explicitly described.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted (or at least, not reported in this summary). The device is an imaging sensor, not an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable to this submission.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an imaging sensor, not an algorithm, so a "standalone" algorithmic performance study as typically understood for AI/ML devices is not applicable. The performance is inherent to the sensor's ability to capture images based on its technical specifications.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for evaluating the imaging performance beyond physical and electrical measurements. The "Non-clinical & Clinical considerations" mention that "all test results were satisfactory," implying some form of objective assessment was conducted, but the specific nature of the ground truth (e.g., expert consensus, pathology, outcomes data) for image quality or diagnostic accuracy is not detailed. The primary ground for acceptance appears to be substantial equivalence to a predicate device based on technical specifications and conformance to safety and EMC standards.

8. The Sample Size for the Training Set

This information is not applicable as the EzSensor P is a digital X-ray sensor, not an AI/ML device that requires a training set.

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

This information is not applicable as the EzSensor P is a digital X-ray sensor, not an AI/ML device that requires a training set.

Summary

{0}------------------------------------------------

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

March 30, 2012

Manufacturer

HUMANRAY Co., Ltd.

1,3F 23-8, Seokwoo-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic

Tel: +82-31-8015-6264

Fax: +82-31-8015-6394

Contact person: Mr. Sang-Wook, Yang

United States Sales Representative (U.S. Designated agent)

Dave Kim / Mtech Group 12946 Kimberly Ln, Houston, TX 77079 Tel: +713-467-2607 Fax: +713-464-8880 Contact person: Mr. Dave Kim

EzSensor P Trade/Proprietary Name:

Common Name:

Medical Image Processing Unit

Classification Name:

Solid State X-Ray Imager (21CFR 892.1650, Product Code MQB)

Description:

{1}------------------------------------------------

transferred to personal computer via USB interface port.

Indication for use:

Predicate Device:

Manufacturer	: HUMANRAY Co., Ltd.
Device	: EzSensor T
510(k) Number	: K113360 (Decision Date - February 7th, 2012)

Substantial Equivalence:

The EzSensor P digital intra oral sensor described in this 510(k) has the same intended use and similar technical characteristics as EzSensor T of HUMANRAY Co., Ltd.

Characteristic	ProposedHUMANRAY Co., Ltd.EzSensor P	PredicateHUMANRAY Co., Ltd.EzSensor T
Feature	Image: EzSensor P	Image: EzSensor T
510(k) number	-	K113360
Indicationsfor use	EzSensor P, Intra-oral Imaging System,is intended to collect dental x-rayphotons and convert them into electronicimpulses that may be stored, viewed,and manipulated for diagnostic use bydentists.	EzSensor T, Intra-oral ImagingSystem, is intended to collect dental x-ray photons and convert them intoelectronic impulses that may bestored, viewed, and manipulated fordiagnostic use by dentists.
Device Description	EzSensor P is a solid state x-ray imagerdesigned for dental radiographic	EzSensor T is a solid state x-ray imagerdesigned for dental radiographic

{2}------------------------------------------------

510(k) Submission - EzSensor P

	applications. The EzSensor P digital intraoral sensor provides digital image capture toreplace radiographic film/screen systems ingeneral dental diagnostic procedures. Thecaptured digital image is transferred toPersonal Computer via USB interface port.	applications. The EzSensor T digital intraoral sensor provides digital image captureto replace radiographic film/screensystems in general dental diagnosticprocedures. The captured digital image istransferred to Personal Computer via USBinterface port.
SensorDimension(mm)	Size "1.5" : 38.7 x 29.2Size "2.0" : 42.8 x 31.5	Size "1.0" : 36.8x26.1Size "1.5" : 38.7x29.2Size "2.0" : 42.8x31.5
SensorThickness	4.95	4.95
Active Area(mm)	Size "1.5" : 24.01 x 33.04Size "2.0" : 26.04 x 36.05	Size "1.0" : 20.02x30.03Size "1.5" : 24.01x33.04Size "2.0" : 26.04x36.05
USB Module	Integrated USB 2.0 module	Integrated USB 2.0 module
Pixel Size(\u03bcm)	20x20	35x35
Pixel Matrix	Size "1.5" : 1200x1650 pixelSize "2.0" : 1300x1800 pixel	Size "1.0" : 572x858 pixelSize "1.5" : 686x944 pixelSize "2.0" : 744x1030 pixel
PixelPitch (Spacing)	0.02 mm x 0.02 mm	0.035 mm x 0.035 mm
TheoreticalResolution	25 lp/mm	14.1 lp/mm

The indications for use, material, form factor, performance, and safety characteristics between EzSensor P and its predicate device are the same. The primary difference is Pixel size, Pixel matrix, Pixel pitch, Resolution and Scintillator materials; Cesium iodide(Csl) for EzSensor P and GOS(Gd2O2S:Tb) for EzSensor T, respectively. Accordingly we can claim the substantially equivalence of EzSensor P to the predicate device.

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-1(2nd edition, 2000) for use with IEC60601-1(Al+A2, 1995) 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

{3}------------------------------------------------

Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

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. HUMANRAY Co., Ltd. concludes that EzSensor P is safe and effective and substantially equivalent to predicate device as described herein.

END

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Humanray Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberly Lane HOUSTON TX 77079

MAY 1 0 2012

Re: K121132

Trade/Device Name: EzSensor P Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: April 13, 2012 Received: April 13, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{5}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use Statement

510(K) Number (if known):

· Device Name: EzSensor P

Classification: Solid State X-Ray Imager

Indications for Use:

EzSensor P, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, and manipulated for diagnostic use by dentists. ·

Prescription Use______________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off)
Division of Radiological Devices

ર્દ્ર OK

Division of Rediolog Office of In

Page 1 of 1

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.