This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

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

Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points.

It's important to note that this document is a 510(k) summary for a medical monitor (32HL512D) intended for displaying radiological images. It is not an AI/algorithm-based diagnostic device. Therefore, many of your questions related to AI performance, ground truth, expert consensus, MRMC studies, and training sets will not be applicable to this submission. The "device" in this context is a monitor, not a diagnostic algorithm.

Acceptance Criteria and Device Performance for LG 32HL512D Medical Monitor

The acceptance criteria for this device (a medical monitor) are primarily related to its technical specifications for displaying medical images and compliance with electrical safety and EMC standards. The "performance" is demonstrated by meeting these specifications and showing compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from predicate or general medical display requirements)	Reported Device Performance (LG 32HL512D)
Indications for Use	Display radiological images for review, analysis, and diagnosis by trained medical practitioners. Not intended for mammography.	This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography. (Matches exactly)
Electrical Safety	Compliance with IEC 60601-1:2005/AMD1:2012	Complies with IEC 60601-1:2005/AMD1:2012
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 Edition 4.0:2014	Complies with IEC 60601-1-2 Edition 4.0:2014
Usability	Compliance with IEC 60601-1-6:2010/A1:2013	Complies with IEC 60601-1-6:2010/A1:2013
Software Validation (if applicable)	Designed and developed according to a software development process; verified and validated (for MODERATE level of concern software)	Software was designed and developed according to a software development process and was verified and validated. (MODERATE level of concern)
Resolution	(Implied comparison to predicate/PACS needs)	3,840 x 2,160 pixels
Screen Size	(Implied comparison to predicate/PACS needs)	718.2 x 414.3 mm (or 31.5" diagonal through module description)
Display Technology	TFT LCD with specific display capabilities for medical images.	TFT Liquid Crystal Display module with LED Backlight unit, 30-pin eDP port, 4 lane eDP interface, supports 3840 x 2160 UHD mode, 10-bit drivers.
Pixel Pitch	(Implied comparison to predicate/PACS needs)	0.18159 x 0.18159 mm
Input Video Signals	Standard video inputs for medical imaging systems.	DisplayPort x 2, HDMI x 1

Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable acceptance thresholds for all performance parameters in the context of a new, unique claim. Its performance is accepted if it is shown to be as safe and effective as the predicate, despite technological differences. The "reported device performance" are its specifications and compliance with standards.

Regarding the Study Proving Device Meets Acceptance Criteria:

The document states: "No clinical studies were considered necessary and performed." This is crucial. This is a submission for a medical display monitor, not a diagnostic algorithm or device that makes a clinical determination. Therefore, the "study" proving it meets acceptance criteria is primarily non-clinical testing and a comparison to a predicate device.

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

Sample Size: Not applicable in the context of patient data or algorithm performance. The "test set" for a monitor would be the monitor itself undergoing various electrical, EMC, and display characteristic tests.
Data Provenance: Not applicable. The testing is on the physical monitor, not a dataset.

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

Not applicable. There is no "ground truth" to establish in the sense of medical diagnoses for this device. The device itself is the display. The "experts" involved would be engineers and metrologists conducting the technical measurements and ensuring compliance with display standards and safety regulations.

4. Adjudication Method for the Test Set:

Not applicable. This concept pertains to resolving discrepancies in expert interpretations of medical data, which is not relevant for a medical monitor.

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

No, not performed. This type of study is relevant for evaluating the impact of AI algorithms or new diagnostic methods on human reader performance. As this is a medical monitor, an MRMC study is not part of its substantial equivalence demonstration.

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

No, not applicable. This device is a monitor, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used:

Not applicable. There is no 'ground truth' in the clinical diagnostic sense for a medical display monitor. The "ground truth" for its performance is its measured technical specifications and compliance with relevant industry and safety standards (e.g., DICOM Part 14 for display characteristics, IEC standards for safety).

8. The Sample Size for the Training Set:

Not applicable. This device does not use a training set as it is not an AI/machine learning algorithm.

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

Not applicable. No training set exists for this device.

Summary

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

March 13, 2020

Re: K192925

Trade/Device Name: 32HL512D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: February 6, 2020 Received: February 14, 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) K192925

Device Name 32HL512D

Indications for Use (Describe)

This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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)]

K192925

February 7, 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:	32HL512D
---------------	----------

. 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:	K131090
Applicant:	EIZO Corporation
Classification Name:	Picture archiving and communications system

Trade Name: RadiForce MX215 ●

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

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

This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

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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 (32HL512D) and the legally marketed predicate device (K131090):

	Proposed Device	Predicate Device
K Number	Not known	K131090
Manufacturer	LG Electronics Inc.	EIZO Corporation
Model Name	32HL512D	RadiForce MX215
Classification Name	Picture archiving andcommunications system	Picture archiving andcommunications system
Classification Number	21 CFR 892.2050	21 CFR 892.2050
Indications for Use	This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography.	This product is intended to beused in displaying and viewingdigital images for review andanalysis by trained medicalpractitioners. It does not supportthe display of mammographyimages for diagnosis.
Display Technology	The 32HL512D has a LM315WR2module for displaying. TheLM315WR2 is a 31.5" TFT LiquidCrystal Display module with LEDBacklight unit and one 30-pineDP port has 4 lane eDPinterface. This module supports3840 x 2160 UHD mode and candisplay color driven by 10bitdrivers.	RadiForce MX215 is a color LCDmonitor for viewing medicalimages other than those ofmammography. The color panelemploys in-plane switching (IPS)technology allowing wideviewing angles and the matrixsize (or resolution) is 1,200 x1,600 pixels (2MVP).
Power Consumption	MAX. 65WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W	Max. 48WStandby < 0.5W
Screen size	718.2 x 414.3 mm	54 cm / 21.3"
LCD Screen	TFT LCD	TFT LCD
Pixel Pitch	0.18159 x 0.18159 mm	0.270 x 0.270 mm
Resolution	3,840 x 2,160 pixels	1,200 x 1,600 pixels
Horizontal Frequency	30 kHz to 135kHz	24 kHz to 80 kHz
Vertical Frequency	56 Hz to 61 Hz	49 Hz to 76 Hz
Viewing angle	View angle free (R/L 178(Typ.),U/D 178(Typ.))	Horizontal: 178°, vertical: 178°
Input video signals	DisplayPort x 2HDMI x 1	DisplayPort x 1DVI-I x 1

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

The comparison table shows that the subject device (32HL512D) has the similar indications for use the predicate one. Although the devices have some different technological characteristics (screen size, pixel pitch, resolution, horizontal/vertical frequency), 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 devise do not raise different questions of safety and

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effectiveness. It is substantially equivalent to a predicate device in indications for use and technology characteristics.

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 32HL512D 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 quidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.

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 32HL512D 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).