This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. The display is not intended for mammography.

Device Description

The 21HK512D is a 21.3" LCD display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical monitor (21HK512D) by LG Electronics Inc. It focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce RX350). The key takeaway regarding this device's performance validation is: No clinical studies were considered necessary and performed.

Therefore, the requested information regarding acceptance criteria, proven device performance through a study, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from this document, as a clinical performance study was not conducted for this device.

The document primarily relies on non-clinical testing for electrical safety, electromagnetic compatibility, usability, and software validation. It asserts substantial equivalence based on comparable intended use and technological characteristics with the predicate device.

Here's a breakdown of what can be extracted and why other points cannot:

A table of acceptance criteria and the reported device performance
- Not applicable for clinical performance. The document states "No clinical studies were considered necessary and performed."
- For non-clinical tests, it states compliance with standards:
  - Acceptance Criteria (Implied): Compliance with IEC 60601-1:2005/AMD1:2012 (Electrical Basic Safety and Essential Performance), IEC 60601-1-2 Edition 4.0:2014 (Electromagnetic Compatibility), and IEC 60601-1-6:2010/A1:2013 (Usability).
  - Reported Performance: "The test results demonstrated that the proposed device complies with the following standards." (For software: "The 21HK512D contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.")
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for clinical performance. No clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No clinical test was performed with associated ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test was performed.
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. This device is a medical monitor, not an AI-assisted diagnostic tool. No MRMC study was done.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (monitor), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical performance study was conducted.
The sample size for the training set
- Not applicable. This device does not use a training set as it's a monitor, not an AI algorithm.
How the ground truth for the training set was established
- Not applicable. This device does not use a training set.

In summary, the provided text details the regulatory submission for a medical monitor and explicitly states that no clinical studies were performed. The device's safety and effectiveness were demonstrated through non-clinical testing and a comparison of technological characteristics to a predicate device, as opposed to a performance study involving patient data or expert readers.

Summary

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December 5, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is 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: K191864

Trade/Device Name: 21HK512D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: September 30, 2019 Received: October 7, 2019

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for 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.

Michael D. O'Hara 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) K191864

Device Name 21HK512D

Indications for Use (Describe)

This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. The display is not intended for mammography.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face within a circle and the letters "LG" in a sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller font. The face and the circle are in a shade of red, while the letters and the slogan are in gray.

222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, Republic of Korea Tel: +82-31-8066-5641

510(k) Summary

[As Required by 21 CFR 807.92]

K191864

1. Date of submission

July 5, 2019

2. Submitter's Information

• 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,Republic of Korea

3. Trade Name, Common Name, Classification

Trade Name: ● 21HK512D
Common Name: Medical Monitor ●
. 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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Image /page/4/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face within a circle on the left, and the letters "LG" in gray on the right. Below the letters "LG" is the slogan "Life's Good" in a smaller font.

4. Identification of Predicate Device(s)

The identified predicate device within this submission are shown as follow:

Predicate Device

510(k) Number: K153354
Applicant: EIZO Corporation
Classification Name: Picture archiving and communications system ●
Trade Name: RadiForce RX350

5. Description of the Device

6. Indications for Use

This Medical Monitor is intended to be used by trained medical practitioners for displaying, and analysis of medical images. The display is not intended for mammography.

7. Determination of Substantial Equivalence

The comparison table shows that the subject device (21HK512D) has the same intended use as the predicate one. Although the devices have some different technological characteristics, 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. It is substantially equivalent to a predicate device in indications for use and technology characteristics.

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Image /page/5/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face in a circle and the letters "LG" in a bold, sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller, lighter font.

222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, Republic of Korea Tel: +82-31-8066-5641

	Proposed Device	Predicate Device
K Number	Not known	K153354
Manufacturer	LG Electronics Inc.	EIZO Corporation
Model Name	21HK512D	RadiForce RX350
Classification Name	Picture archiving and	Picture archiving and
	communications system	communications system
Classification Number	21 CFR 892.2050	21 CFR 892.2050
Indications for Use	This Medical Monitor is intendedto be used by trained medicalpractitioners for displaying,reviewing, and analysis ofmedical images. The display isnot intended for mammography.	This product is intended to beused in displaying and viewingdigital images for review,analysis and diagnosis by trainedmedical practitioners. It does notsupport the display ofmammography images fordiagnosis.
LCD Screen	TFT LCD	TFT LCD
Pixel Pitch	0.2115 x 0.2115 mm	0.2115 x 0.2115 mm
Resolution	2,048 x 1,536 pixels	1,536 x 2.048 pixels

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Image /page/6/Picture/0 description: The image shows the logo for LG. The logo consists of a red circle with the letters "L" and "G" inside, and the letters "LG" in gray next to the circle. Below the letters "LG" is the phrase "Life's Good" in a smaller font.

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 21HK512D contains MODERATE level of concern 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.

8. Conclusion

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 21HK512D 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).