The Medical LCD Monitor is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

Device Description

The Medical LCD Monitor (Model: KT-D213V5E) is designed for the purpose of medical applications such as X-ray, radiology, MRI, endoscopy or mammography imaging display. The high-resolution LCD panel with a resolution of 2560 x 2048, combined with a high performance image processing controller, provides the users high-definition and high-quality medical image displays. The medical monitor complies with international EMC/ safety standards.

AI/ML Overview

The provided document is a 510(k) premarket notification for a Medical LCD Monitor (Model: KT-D213V5E) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven medical device, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an AI/ML model's performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device based on this document. The document describes a medical display monitor and its technical specifications, along with standard performance tests to ensure basic functionality and safety/effectiveness consistent with its predicate.

The "Performance Data" section lists several tests performed on the subject device and states that "passed the pre-set criteria," but it does not specify what those criteria are or provide any detailed results.

Here's a summary of what is available in the document, which might be similar to how a non-AI medical device would list performance:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests that were conducted and states they "passed the pre-set criteria," but it does not provide the specific acceptance criteria or detailed reported performance data for these tests.

Performance Test	Acceptance Criteria	Reported Device Performance
Luminance Response	Not Specified	Passed pre-set criteria
Uniformity	Not Specified	Passed pre-set criteria
Miscellaneous Test	Not Specified	Passed pre-set criteria
Display Reflection	Not Specified	Passed pre-set criteria
Angular dependencies	Not Specified	Passed pre-set criteria
Clinical Reference Image	Not Specified	Passed pre-set criteria
Geometric Distortion	Not Specified	Passed pre-set criteria
Display Noise	Not Specified	Passed pre-set criteria
Display Veiling Glare	Not Specified	Passed pre-set criteria
Scheduler Table	Not Specified	Passed pre-set criteria
EMC and Electrical Safety Tests	Not Specified	Passed pre-set criteria
Software Verification and Validation	Not Specified	Passed pre-set criteria

Since the device described is a Medical LCD Monitor and not an AI/ML algorithm, the following points are not applicable and cannot be answered based on the provided text:

2. Sample size used for the test set and the data provenance (Not applicable for a display monitor's technical performance tests)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable, as "ground truth" in the context of expert diagnosis from images is not relevant for a display monitor's technical performance)
4. Adjudication method for the test set (Not applicable)
5. 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 (Not applicable, as this is not an AI device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable, as this is not an AI algorithm)
7. The type of ground truth used (Not applicable)
8. The sample size for the training set (Not applicable, as there is no training set for a display monitor)
9. How the ground truth for the training set was established (Not applicable)

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

August 4, 2014

Kostec Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E. Chapman Avenue, Suite 110 FULLERTON CA 92831

Re: K141891

Trade/Device Name: Medical LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 7, 2014 Received: July 14, 2014

Dear Ms. Chung:

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.

FDA

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

510(k) Number (if known)

K141891

Device Name Medical LCD Monitor

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)

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)

Image /page/2/Figure/14 description: The image shows a signature in black ink over a light gray FDA logo. The signature is illegible, but appears to be cursive. The FDA logo is a triangle with the letters "FDA" inside.

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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: 08/01/2014

1. Applicant / Submitter

KOSTEC Co., Ltd. #2-101, Medical Industry Technocenter, 1720-26 Taejang-dong, Wonju-si, Kangwon-do, 220-120, Republic of Korea Phone: +82-33-747-9672 Fax: +82-33-747-9673

2. Submission Correspondent

LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton, CA 92831 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: Medical LCD Monitor (Model: KT-D213V5E)
· Classification Name: Picture archiving and communications system
· Classification regulation: 21 CFR 892.2050
Product Code: PGY

4. Predicate Device:

Wide 5MP (Mammo) LCD Monitor System (K052312) by WIDE Corporation

5. Description:

6. Indications for use:

The Medical LCD Monitor is intended to be used in displaying and viewing medical digital images

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for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

7. Comparison to the Cleared Device

The Medical LCD Monitor (KT-D213V5E) is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The specifications of the primary component employed by the subject device are the same as those of the predicate device and other differences have been independently validated. Any differences such as clock speed between the devices do not affect safety or effectiveness.

	Predicate Device	Subject Device
Device Name	5MP (Mammo) LCD MonitorSystem	Medical LCD Monitor
510K Number	K052312	-
Manufacturer	WIDE Corporation	Kostec Co., Ltd.
Indications for Use	The 5MP (Mammo) LCDMonitor System is intended tobe used in displaying andviewing medical digital imagesfor review and analysis bytrained medical practitioners. Itis specifically designed fordigital mammographyapplications.	The Medical LCD Monitor isintended to be used indisplaying and viewing medicaldigital images for review andanalysis by trained medicalpractitioners. It is specificallydesigned for digitalmammography applications.
Panel	TFT AMLCD IPS	TFT AMLCD IPS
Screen size	21.3"(422.4(H) x 337.92(V)[mm])	21.3"(422.4(H) x 337.92(V)[mm])
Pixel pitch	0.165(H) x 0.165(V) [mm]	0.165(H) x 0.165(V) [mm]
Contrast ratio	850:1	850:1
Declared and actual array size	422.4(H)x337.92(v)mm	422.4(H)x337.92(v)mm
Max and min achievableluminance	Typ: 1,100 cd/m2	Typ: 1,100 cd/m2
Luminance Calibration	Software(Optional)Sensor (optional)	Software(Optional)Sensor (optional)
Intrinsic bit-depth of the panel	8bit	8bit
True output bit-depth byperforming visual test	14bit	14bit
Luminance Uniformity	min : 70L.U =(Min.lum/Max.lum.)*100	min : 70L.U =(Min.lum /Max.lum.)*100
Chromaticity measured at 5, 50and 95% (fefxox ISO13406-2)	x:0.294, y:0.309	x:0.294, y:0.309
Clock speed	64.5MHz	74 MHz
Spatial resolution, spatial MTF	2,560(H)x2,048(V)	2,560(H)x2,048(V)

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8. Performance Data

The following tests have been performed on the subject device and passed the pre-set criteria.

Luminance Response
Uniformity
Miscellaneous Test
Display Reflection
Angular dependencies
Clinical Reference Image
Geometric Distortion
Display Noise
Display Veiling Glare
Scheduler Table
EMC and Electrical Safety Tests
Software Verification and Validation

9. Conclusion

We have concluded that our devices are substantially equivalent to the predicate device in safety and effectiveness. No new questions of safety and effectiveness have been raised.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).