This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Device Description

The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images

AI/ML Overview

This document describes the 510(k) premarket notification for the LG Electronics 31HN713D Medical Monitor. The submission aims to demonstrate substantial equivalence to a predicate device (BARCO N.V. MDMC-12133, K141428) for displaying radiological images, including full-field digital mammography and digital breast tomosynthesis.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-clinical tests performed in accordance with FDA guidance for "Display Devices for Diagnostic Radiology." The reported device performance is indicated by the outcome of these tests being deemed "Equivalent" or "Same" to the predicate device, suggesting the device met the necessary performance standards to be considered substantially equivalent.

Acceptance Criterion (Implied by Test Item)	Description of Test	Reported Device Performance (SE Note)
Spatial resolution	Measurements of the transfer of information from the image data to the luminance fields at different spatial frequencies, typically by reporting the modulation transfer function. Non-isotropic resolution properties characterized by 2D measurements or along at least two representative axes (Using TG18 QC Test Pattern).	Equivalent
Pixel defects	Measurements (count, types (e.g., sub-pixel or entire pixel, always-on, always-off), and locations (map) of pixel defects. Provided as a tolerance limit. Pixel defects can interfere with the visibility of small details.	Equivalent
Artifacts	Evaluate for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern for a period of time (Using 5x5 mosaic pattern, 64Gray / 127 Gray judgment).	Same
Temporal response	Measurements of the temporal behavior of the display in responding to changes in image values from frame to frame. Rise and fall time constants are needed. Slow displays can alter details and contrast when large image stacks are browsed or in video, panning, and zooming modes.	Equivalent
Luminance	Measurements of the maximum and minimum luminance that the device outputs under recommended conditions and achievable values if set to expand the range to the limit.	Same
Conformance to a grayscale-to-luminance function	Measurements of the mapping between image values and the luminance output following a target model response for 256 or more levels.	Equivalent
Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners	Measurements of the luminance response at off-normal viewing related to the target model for the luminance response.	Equivalent
Luminance uniformity or Mura test	Measurements of the uniformity of the luminance across the display screen.	Equivalent
Stability of luminance and chromaticity response with temperature and time of operation (on-time)	Measurements of the change in luminance and chromaticity response with temperature and use time.	Same
Spatial noise	Measurements of the spatial noise level as represented by the noise power spectrum using an appropriate ratio of camera and display pixels. Spatial noise and resolution affect how images are presented and can alter features relevant to interpretation.	Equivalent
Reflection coefficient	Measurements of the reflection coefficients of the display device. Specular and diffuse reflection coefficients can be used as surrogates for the full bidirectional reflection distribution function.	Same
Veiling glare or small-spot contrast	Measurements of the contrast obtained for small targets.	Equivalent
Color tracking	Chromaticity at different luminance levels of primary colors as indicated by the color coordinates in an appropriate units system (e.g., CIE u'v') and the color gamut enveloped by the primary colors.	Equivalent
Gray tracking	Chromaticity at different luminance levels of gray shades, including the white point, as indicated by the color coordinates in an appropriate units system.	Equivalent

2. Sample Size and Data Provenance (Test Set)

Sample Size: Not applicable. The "study" described is a series of non-clinical, technical performance tests on the device itself, rather than a study involving patient data or human readers. The tests involve the physical display unit.
Data Provenance: Not applicable. The tests are conducted on the device hardware and its performance characteristics.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

Number of Experts: Not applicable. There is no involvement of experts establishing ground truth for a test set in the traditional sense, as this is a device performance test. The "ground truth" for these tests comes from established industry standards and guidance (e.g., TG18 QC Test Pattern) and the technical specifications required for medical diagnostic displays.
Qualifications of Experts: Not applicable.

4. Adjudication Method (Test Set)

Adjudication Method: Not applicable. There is no adjudication in the context of the described non-clinical performance tests. The results are based on direct measurements against predefined technical specifications or comparisons to the predicate device's expected performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The document explicitly states: "No clinical studies were considered necessary and performed." This submission focuses on demonstrating substantial equivalence through non-clinical technical performance testing.
Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: Yes, in a way. The tests performed are inherent to the device's standalone performance characteristics as a display monitor. The device itself (the monitor) is tested as a standalone product to ensure it meets the technical specifications for displaying medical images. While it's not an "algorithm," it assesses the fundamental output quality of the device without human interpretation being part of the performance metric.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for these non-clinical tests is derived from technical specifications, industry standards, and regulatory guidance. Specifically, reference is made to:
- IEC 60601-1:2005/AMD1:2012 (Electrical Basic Safety and Essential Performance)
- IEC 60601-1-2 Edition 4.0:2014 (Electromagnetic Compatibility)
- IEC 60601-1-6:2010/A1:2013 (Usability)
- FDA guidance: "Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017"
- Specific test patterns like TG18 QC Test Pattern and 5x5 mosaic patterns are mentioned for certain measurements.

8. Sample Size for the Training Set

Sample Size: Not applicable. This document pertains to the submission of a medical monitor (hardware), not an AI algorithm that requires a training set. The software validation mentioned is for the display's internal operating software, not for image analysis.

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

Ground Truth Establishment: Not applicable, as there is no training set for an AI algorithm discussed in this submission.

Summary

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October 8, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LG Electronics, Inc. % Jinhwan Jun Chief Research Engineer 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-Si. Gyeonggi-do 17709 REPUBLIC OF KOREA

Re: K201777

Trade/Device Name: 31HN713D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: September 7, 2020 Received: September 10, 2020

Dear Jinhwan Jun:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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) K201777

Device Name 31HN713D

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As Required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

K201777

June 25, 2020

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Sponsor:	LG Electronics Inc.
Address:	222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si,Gyeonggi-do, 17709, Republic of Korea
Contact Name:	Jinhwan Jun / Chief Research Engineer
Telephone No.:	+82-31-8066-5641
Email Address:	jinhwan.jun@lge.com
Name of Manufacturer:	LG Electronics Inc.
Address:	77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

• Trade Name:	31HN713D
• Company Name:	Medical Monitor

. Common Name:

Medical Monitor

Republic of Korea

Classification: ●

Classification Name	Picture archiving and communications system
Classification Number	21 CFR 892.2050
Product Code	PGY
Device Class	II
Review Panel	Radiology

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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

Predicate Device

• 510(k) Number:	K141428
• Applicant:	BARCO N.V.
• Classification Name:	Picture archiving and communications system
• Trade Name:	MDMC-12133

5. Description of the Device [21 CFR 807.92(a)(4)]

6. Indications for use [21 CFR 807.92(a)(5)]

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7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]

The table below presents comparisons between the subject device (31HN713D) and the legally marketed predicate device (K141428):

	Proposed Device	Predicate Device
K Number	Not known	K141428
Manufacturer	LG Electronics Inc.	BARCO N.V.
Model Name	31HN713D	MDMC-12133
Classification Name	Picture archiving and communications system	Picture archiving and communications system
Classification Number	21 CFR 892.2050	21 CFR 892.2050
Indications for Use	This Medical Monitor is indicated for usein displaying radiological images(including full-field digital mammographyand digital breast tomosynthesis) forreview, analysis, and diagnosis by trainedmedical practitioners.	The MDMC- 12133 is intended to be usedin displaying arid viewing digital images,including standard and multi-framedigital mammography. for review,analysis and diagnosis by trained medicalpractitioners. It is especially designed forbreast tomosynthesis applications.
Display Technology	The 31HN713D has a LB310FTMmodule for displaying. The LB310FTM isa 31" TFT Liquid Crystal Display modulewith LED Backlight unit. This modulesupports 4,200 x 2,800 pixels and candisplay color driven by 10bit drivers.	Coronis Uniti Barco is a color LCDmonitor for viewing radiology,mammography, and breasttomosynthesis images. The color panelemploys in-plane switching (IPS)technology allowing wide viewing anglesand the matrix size (or resolution) is4,200 x 2,800 pixels.
Power Consumption	MAX. 150WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W	190W (nominal)<0.5 W (hibernate)
Screen size	676.9 x 459.7 mm	853.44mm / 33.6"
LCD Screen	TFT LCD	TFT LCD
Pixel Pitch	0.1554 x 0.1554 mm	0.1686 x 0.1686 mm
Resolution	4,200 x 2,800 pixels	4,200 x 2,800 pixels
Horizontal Frequency	30 kHz to 135kHz	25-85 Hz
Vertical Frequency	56 Hz to 61 Hz	25-85 Hz
Viewing angle	View angle free (R/L 178(Typ.), U/D178(Typ.))	178°
Input video signals	DisplayPort x 2HDMI x 1	DisplayPort x 2

[Table 1. Comparison of Proposed Device to Predicate Device]

The comparison table shows that the subject device (31HN713D) has the similar indications for use the predicate device. Although the devices have some different technological characteristics (screen size, pixel pitch, horizontal/vertical frequency and input video signals), these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does. There are no significant differences in the technological characteristics of the subject device. All the differences between the subject and predicate device do not raise different questions of safety and effectiveness. It is substantially equivalent to a predicate device in indications for use and technology characteristics.

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8. Non-Clinical Test summary

1. Electrical Safety and Electromagnetic Compatibility
  The test results demonstrated that the proposed device complies with the following standards:
· Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD1:2012
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2 Edition 4.0:2014
· Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability in accordance with IEC 60601-1-6:2010/A1:2013
1. Software Validation

The 31HN713D contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated.

The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.

1. Guidance
  Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017

	Measurements	Description	SE Note
a.	Spatial resolution	Measurements of the transfer ofinformation from the image data to theluminance fields at different spatialfrequencies of interest typically done byreporting the modulation transferfunction. Non-isotropic resolutionproperties should be characterizedproperly by providing two-dimensionalmeasurements or measurements alongat least two representative axes.(Using TG18 QC Test Pattern)	Equivalent
b.	Pixel defects	Measurements (count, types (e.g., sub-pixel or entire pixel, always-on, always-off), and locations (map) of pixeldefects. This is typically provided as atolerance limit. Pixel defects caninterfere with the visibility of smalldetails in medical images.	Equivalent
c.	Artifacts	Evaluate for image artifacts such asghosting and/or image sticking fromdisplaying a fixed test pattern for aperiod of time.(Using 5x5 mosaic pattern, 64Gray /127 Gray judgment)	Same
d.	Temporal response	Measurements of the temporal behaviorof the display in responding to changesin image values from frame to frame.Since these transitions are typically notsymmetric, rise and fall time constants	Equivalent
Measurements	Description	SE Note
	are needed to characterize the system.Slow displays can alter details andcontrast of the image when large imagestacks are browsed or in video,panning, and zooming modes.
e. Luminance	Measurements of the maximum andminimum luminance that the deviceoutputs as used in the application underrecommended conditions and theachievable values if the device is set toexpand the range to the limit.	Same
f. Conformance to agrayscale-to-luminancefunction	Measurements of the mapping betweenimage values and the luminance outputfollowing a target model response for256 or more levels.	Equivalent
g. Luminance at 30° and 45°in diagonal, horizontal,and vertical directions atcenter and four corners	Measurements of the luminanceresponse at off-normal viewing relatedto the target model for the luminanceresponse.	Equivalent
h. Luminance uniformity orMura test	Measurements of the uniformity of theluminance across the display screen.	Equivalent
i. Stability of luminance andchromaticity responsewith temperature and timeof operation (on-time)	Measurements of the change inluminance and chromaticity responsewith temperature and use time.	Same
j. Spatial noise	Measurements of the spatial noise levelas represented by the noise powerspectrum using an appropriate ratio ofcamera and display pixels. Spatial noiseand resolution affect the way imagesare presented to the viewer and canalter features that are relevant to theinterpretation process of the physicianor radiologist.	Equivalent
k. Reflection coefficient	Measurements of the reflectioncoefficients of the display device.Specular and diffuse reflectioncoefficients can be used as surrogatesfor the full bidirectional reflectiondistribution function.	Same
l. Veiling glare or small-spotcontrast	Measurements of the contrast obtainedfor small targets.	Equivalent
m. Color tracking	Chromaticity at different luminancelevels of primary colors as indicated bythe color coordinates in an appropriateunits system (e.g., CIE u'v') and thecolor gamut enveloped by the primarycolors.	Equivalent
n. Gray tracking	Chromaticity at different luminancelevels of gray shades, including thewhite point, as indicated by the colorcoordinates in an appropriate unitssystem	Equivalent

According to the quidance, we test following performance items:

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According to the above test results, there are no significant performance differences between 31HN713D and the predicate device that would adversely affect the use of the product. It has substantially equivalent performance compared to the predicate device.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

9. Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification LG Electronics, concludes that the 31HN713D is substantially equivalent in safety and effectiveness to the predicate devices as described herein.

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).