EzSensor T, 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

EzSensor T is a solid state x-ray imager designed for dental radiographic applications. EzSensor T provides digital image capture for conventional film/screen radiographic dental examinations. The device is used 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

Here's an analysis of the provided text regarding the EzSensor T device, focusing on acceptance criteria and study details:

Interpretation of the Document:

The provided document is a 510(k) summary for the EzSensor T, an intra-oral imaging system. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove performance against a set of predefined clinical acceptance criteria using a standalone clinical study. The "acceptance criteria" here largely refer to demonstrating the new device's performance is comparable to or better than the predicate device and meets relevant safety and performance standards.

The document emphasizes non-clinical and clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices". This implies that the 'study' likely involved technical performance tests and comparative analyses against the predicate, rather than a prospective clinical trial with specific diagnostic accuracy endpoints.

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative "acceptance criteria" in the typical sense of diagnostic metrics (e.g., sensitivity, specificity, AUC) for a clinical study. Instead, it focuses on demonstrating equivalence to a predicate device based on technical specifications and adherence to safety and performance standards. The "reported device performance" is primarily a comparison of technical characteristics to the predicate.

Acceptance Criteria (Implied from Substantial Equivalence and Standards)	Reported Device Performance (Comparison with Predicate EzSensor)
Functional Equivalence: Intended to collect dental x-ray photons and convert them into electronic impulses stored, viewed, and manipulated for diagnostic use by dentists.	Equivalent: Both EzSensor T and EzSensor share the exact same Indications for Use.
Device Description Equivalence: Solid state x-ray imager for digital image capture in general dental diagnostic procedures, transferring images via USB.	Equivalent: Both EzSensor T and EzSensor share the same fundamental device description and method of operation.
Technical Specifications (Spatial Resolution): Comparable or better spatial resolution.	Comparable: EzSensor T: 14.28 lp/mm (Intrinsic Property), EzSensor: 14.3 lp/mm (Intrinsic Property). Pixel size and pitch are identical (35x35 µm, 0.035 mm x 0.035 mm).
Safety and EMC Standards Compliance: Adherence to relevant electrical, mechanical, and environmental safety standards (e.g., IEC 60601-1, IEC 60601-1-2).	Compliant: "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-1(2ª edition, 2000) [...] and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007. All test results were satisfactory."
FDA Guidance Compliance: Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices".	Compliant: "Non-clinical & Clinical considerations according to FDA Guidance [...] was performed. All test results were satisfactory."
Image Quality (Implied): Production of images suitable for diagnostic use.	Not explicitly quantified in terms of clinical diagnostic performance metrics (e.g., sensitivity/specificity for specific dental conditions) in this summary, but implied by technical equivalence and satisfactory non-clinical/clinical considerations as per FDA guidance.
Primary Differences Justification: Any differences in materials or dimensions should not negatively impact safety or effectiveness.	Justified: Primary differences (sensor size, active area, scintillator material: GOS for EzSensor T vs. CsI for EzSensor) are acknowledged and deemed not to compromise substantial equivalence.

Study Details

Given the nature of a 510(k) summary for substantial equivalence, especially for an imaging device replacing another with similar function, the "study" is primarily a series of non-clinical technical tests and a comparative analysis against the predicate, guided by FDA regulations. It is not presented as a traditional clinical trial.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a 'test set' with a specific number of images or patients for diagnostic accuracy assessment. The "all test results were satisfactory" refers to engineering and performance tests.
- Data Provenance: Not applicable in the context of a retrospective/prospective clinical data set for diagnostic performance. The data provenance is from laboratory and engineering testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving expert readers establishing ground truth for a diagnostic test set. The focus is on technical performance and equivalence.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a diagnostic test set requiring adjudication in this summary.
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 performed or mentioned. The device is a direct-capture digital X-ray sensor, not an AI-powered diagnostic aide designed to enhance human reader performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The "standalone" performance in this context refers to the intrinsic technical performance of the imaging device itself (e.g., resolution, pixel size, EMC compliance) without a human interpreting images. The listed technical specifications (resolution, pixel matrix, etc.) are characteristics of the device operating in a standalone capacity. "All test results were satisfactory" under "Safety, EMC and Performance Data" implies this.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the typical sense of clinical ground truth. The "ground truth" for the engineering performance tests would be defined by established calibration standards, physical measurements, and regulatory requirements for safe and effective operation of X-ray imaging devices.
The sample size for the training set:
- Not applicable. The EzSensor T is a hardware device (digital X-ray imager for dental applications), not an AI algorithm requiring a training set of data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.

Summary of the "Study" from the document:

The "study" referenced in this 510(k) summary primarily consists of:

Engineering and Performance Testing: Compliance with electrical, mechanical, and environmental safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2). This includes verifying technical specifications like resolution, pixel size, etc.
Comparative Analysis: Side-by-side comparison of technical specifications and Indications for Use with the predicate device (EzSensor K090526) to demonstrate substantial equivalence.
Compliance with FDA Guidance: Adherence to "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices," which likely includes non-clinical and some clinical considerations, but without detailing a full-scale clinical trial with diagnostic endpoints in this summary.

The conclusion is that the EzSensor T is "safe and effective and substantially equivalent to predicate device." This means it meets the regulatory hurdle for market entry based on its similarity to an already approved device and its satisfactory performance in compliance tests.

Summary

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K113360
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Special 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

November 10, 2011

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 Kimberley Ln, Houston, TX 77079

Tel: +713-467-2607

Fax: +713-464-8880

Contact person: Mr. Dave Kim

Trade/Proprietary Name: EzSensor T

Common Name:

Medical Image Processing Unit

Classification Name:

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

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diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.

Indication for use:

Predicate Device:

Manufacturer	: HUMANRAY Co., Ltd.
Device	: EzSensor
510(k) Number	: K090526 (Decision Date - DEC/02/2009)

Substantial Equivalence:

EzSensor T described in this 510(k) has the same intended use and similar technical characteristics as EzSensor (K090526) of HUMANRAY Co., Ltd.

Characteristic	ProposedHUMANRAY Co., Ltd.EzSensor T	PredicateHUMANRAY Co., Ltd.EzSensor
Feature	Image: Proposed HUMANRAY Co., Ltd. EzSensor T	Image: Predicate HUMANRAY Co., Ltd. EzSensor
510(k) number	-	K090526
Indicationsfor use	EzSensor T, 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, Intra-oral Imaging System,is intended to collect dental x-rayphotons and convert themintoelectronic impulses that may bestored, viewed, and manipulated fordiagnostic use by dentists.

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K113360
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Device Description	EzSensor T is a solid state x-ray imagerdesigned for dental radiographicapplications. EzSensor T provides digitalimage capture for conventional film/screenradiographic dental examinations. Thedevice is used to replace radiographicfilm/screen systems in general dentaldiagnostic procedures. The captured digitalimage is transferred to Personal Computervia USB interface port.	EzSensor is a solid state x-ray imagerdesigned for dental radiographicapplications. EzSensor provides digitalimage capture for conventionalfilm/screen radiographic dentalexaminations. The device is used toreplace radiographic film/screen systemsin general dental diagnostic procedures.The captured digital image is transferredto Personal Computer via USB interfaceport.
SensorDimension(mm)	Size "1.0" : 36.8x26.1Size "1.5" : 38.7x29.2Size "2.0" : 42.8x31.5	Size "1.0" : 35.7x25.2Size "1.5" : 38.7x29.2
SensorThickness	4.95	4.9
Active Area(mm)	Size "1.0" : 20.02x30.03Size "1.5" : 24.01x33.04Size "2.0" : 26.04x36.05	Size "1.0" : 20.02x30.03Size "1.5" : 24.08x31.85
USB Module	Integrated USB 2.0 module	Integrated USB 2.0 module
Pixel Size(\u03bcm)	35x35	35x35
Pixel Matrix	Size "1.0" : 572x858 pixelSize "1.5" : 686x944 pixelSize "2.0" : 744x1030 pixel	Size "1.0" : 572x858 pixelSize "1.5" : 686x944 pixel
PixelPitch(Spacing)	0.035 mm x 0.035 mm	0.035 mm x 0.035 mm
Resolution	14.28 lp/mm (Intrinsic Property)	14.3 lp/mm (Intrinsic Property)

The indications for use, material, form factor, performance, and safety characteristics between EzSensor T and the predicate device are the same. The primary differences are size, active area and scintillator layer materials; GOS (Gd2O2S: Tb) for EzSensor T and cesium iodide (CsI) for EzSensor, respectively. Accordingly we can claim the substantially equivalence of EzSensor T.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(2ª edition, 2000) for use with IEC60601-

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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 "Guidance for the 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 T is safe and effective and substantially equivalent to predicate device as described herein. ﻜ

END

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

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

AUG 2 3 2013

Re: K113360

Trade/Device Name: EzSensor T Regulation Number: 21 CFR 872.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MOB Dated: January 11, 2012 Received: January 12, 2012

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of February 7, 2012.

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

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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

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Indications for Use Statement

510(K) Number (if known):

Device Name: EzSensor T

Classification: Solid State X-Ray Imager

Indications for Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ V 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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation(ODE)

Susan Sign-On

Onesium a fracturing all Devices Office of in V hag "un" the tiened Evaluation and Salen

K113360

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Regulation Number and Section

§ 872.1810 Intraoral source x-ray system.

(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.