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

The provided text describes a 510(k) premarket notification for a medical monitor, 24HR513C, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or AI algorithm effectiveness.

The document primarily focuses on demonstrating substantial equivalence to predicate medical monitors based on technological characteristics and non-clinical performance (electrical safety, EMC, software validation, and display performance measurements).

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them, as it is not present in the given text.

Here's what I can extract from the provided text, indicating what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" for clinical performance are mentioned, nor is there a study reporting device performance against such. The document discusses technological characteristics of the monitor itself and its compliance with certain standards for electrical safety, EMC, and software validation.

The "Measurements" table under "Non-Clinical Test summary" (pages 9-10) describes performance items for the display, but these are general display characteristics and not explicitly stated as "acceptance criteria" with quantitative targets met by a device study. Instead, they are evaluated for "Equivalence" or "Same" to predicate devices.

Measurements	Description (as in text)	Reported Device Performance / Equivalence Statement
a. Spatial resolution	Measurements of the transfer of information from the image data to the luminance fields at different spatial frequencies of interest typically done by reporting the modulation transfer function. Non-isotropic resolution properties should be characterized properly by providing two-dimensional measurements or measurements along at 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 pixel defects. This is typically provided as a tolerance limit. Pixel defects can interfere with the visibility of small details in medical images.	Equivalent
c. 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
d. Temporal response	Measurements of the temporal behavior of the display in responding to changes in image values from frame to frame. Since these transitions are typically not symmetric, rise and fall time constants are needed to characterize the system. Slow displays can alter details and contrast of the image when large image stacks are browsed or in video, panning, and zooming modes.	Equivalent
e. Luminance	Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values if the device is set to expand the range to the limit.	Same
f. 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
g. 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

2. Sample size used for the test set and data provenance:

Not Applicable. No test set for clinical performance is mentioned. The non-clinical tests relate to the monitor's display characteristics and software validation. Data provenance for these technical tests is not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and qualifications:

Not Applicable. No clinical test set with ground truth established by experts is mentioned. The device is a medical monitor, not an AI diagnostic tool that requires expert ground truth for image interpretation.

4. Adjudication method for the test set:

Not Applicable. As no clinical test set is mentioned, no adjudication method is relevant.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No. The document explicitly states: "No clinical studies were considered necessary and performed." This device is a medical monitor, not an AI-powered diagnostic aide, so an MRMC study comparing human readers with and without AI assistance is not relevant to its clearance.

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

Not Applicable. The device is a medical monitor. This question pertains to AI algorithms, which are not described here.

7. The type of ground truth used:

Not Applicable. No clinical ground truth (expert consensus, pathology, outcomes data) is mentioned as no clinical studies were performed. The non-clinical tests rely on technical specifications and established standards.

8. The sample size for the training set:

Not Applicable. There is no mention of a "training set" as this device is a medical monitor, not an AI model requiring a training dataset.

9. How the ground truth for the training set was established:

Not Applicable. As no training set is mentioned, this information is not relevant.

In summary, the provided document focuses on the technical specifications and non-clinical testing of a medical monitor to demonstrate its substantial equivalence to previously cleared devices. It explicitly states that "No clinical studies were considered necessary and performed," indicating that the type of performance data and acceptance criteria you're asking about (which generally relate to diagnostic accuracy or clinical utility) are not part of this 510(k) submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. % JongHyun Kim Chief Consultant GMS Consulting #B-612, 66 Chengcho-ro Gyeonggi-do, Goyang-si 10543 Korea, South

Re: K232985

December 11, 2023

Trade/Device Name: 24hr513c Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: November 22, 2023 Received: November 22, 2023

Dear JongHyun Kim:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232985

Device Name 24HR513C

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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K232985 510(k) Summary

[As Required by 21 CFR 807.92]

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

SEPT 22, 2023

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

Name of Sponsor: ● LG Electronics Inc.
222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek si, -Address:
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: 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do, -39368, Republic of Korea

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

Trade Name: 24HR513C
Common Name: Medical Monitor ●
Classification: ●

Classification Name	Medical image management and processing 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;

Primary Predicate Device

510(k) Number:•	K223789
Applicant:•	LG Electronics
Classification Name:•	Medical image management and processing system
Trade Name:•	21HQ513D
Secondary Predicate Device

• 510(k) Number:	K221136
• Applicant:	EIZO Corporation
• Classification Name:	Medical image management and processing system
• Trade Name:	RadiForce MX243W

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 (24HR513C) and the legally marketed predicate devices (K223789 and K221136):

	Proposed Device	Primary Predicate Device
K Number	K232985	K223789
Manufacturer	LG Electronics Inc.	LG Electronics Inc.
Model Name	24HR513C	21HQ513D
Classification Name	Medical image managementand processing system	Medical image managementand processing system
Classification Number	21 CFR 892.2050	21 CFR 892.2050
Indications for Use	This Medical Monitor isindicated for use in displayingradiological images for review,analysis, and diagnosis bytrained medical practitioners.The display is not intended formammography.	This Medical Monitor isindicated for use in displayingradiological images for review,analysis, and diagnosis bytrained medical practitioners.The display is not intended formammography.
Power Consumption	MAX. 65WSleep Mode (Standby Mode):≤ 0.5WOff Mode ≤ 0.3W	MAX. 120WOff Mode ≤ 0.3W
LCD Screen	TFT LCD	TFT LCD
Pixel Pitch	0.27 x 0.27 mm	0.2115 x 0.2115 mm
Resolution	MaxResolution/RecommendedResolution	1920 x 1200@ 60Hz([ScreenRotation]:[Landscape])1200 x 1920@ 60Hz([ScreenRotation]:[Portrait -90°],[Portrait +90°])	1,536 x 2,048 pixels
Horizontal Frequency	30 kHz to 83kHz([Screen Rotation]:[Landscape])30 kHz to 120kHz ([ScreenRotation]: [Portrait -90°],[Portrait +90 °])	30 Hz to 130 Hz
Vertical Frequency	56 Hz to 61 Hz	56 Hz to 61 Hz
Input video signals	DVI IN x 1	DisplayPort x 2

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	DP IN x 1HDMI x 1	DVI-IN x 1
Calibration tools	Calibration software:LG Calibration Studio Medical	Calibration software:PerfectLum / LG CalibrationStudio Medical
	Proposed Device	Secondary Predicate Device
K Number	K232985	K221136
Manufacturer	LG Electronics Inc.	EIZO Corporation
Model Name	24HR513C	RadiForce MX243W
Classification Name	Medical image managementand processing system	Medical image managementand processing system
Classification Number	21 CFR 892.2050	21 CFR 892.2050
Indications for Use	This Medical Monitor isindicated for use in displayingradiological images for review,analysis, and diagnosis bytrained medical practitioners.The display is not intended formammography.	This Product is indicated foruse in displaying radiologicalimages for review, analysis,and diagnosis by trainedmedical practitioners. Thedisplay is not intended formammography.
Power Consumption	MAX. 65WSleep Mode (Standby Mode): ≤0.5WOff Mode ≤ 0.3W	MAX. 56WOff Mode: 0.6W or less
LCD Screen	TFT LCD	TFT LCD
Pixel Pitch	0.27 x 0.27 mm	0.27 x 0.27 mm
Resolution	MaxResolution/RecommendedResolution	1920 x 1200@ 60Hz([ScreenRotation]:[Landscape])1200 x 1920@ 60Hz([ScreenRotation]:[Portrait -90o],[Portrait +90o])	1920 x 1200
Horizontal Frequency	30 kHz to 83kHz([Screen Rotation]:[Landscape])30 kHz to 120kHz ([ScreenRotation]: [Portrait -90o],[Portrait +90 o])	31 - 76 kHz
Vertical Frequency	56 Hz to 61 Hz	59 - 61 Hz
Input video signals	DVI IN x 1DP IN x 1HDMI x 1	DVD-D x 1DisplayPort x 1
Output video signals	DP Out x 1	DisplayPort x 1
Calibration tools	Calibration software:	Calibration software: RadiCS

The comparison table shows that the subject device (24HR513C) has the similar indications for use the primary predicate device. Although the devices have some different technological characteristics (Power Consumption, Pixel Pitch, Resolution, horizontal/vertical frequency and input/output 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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|--|

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	LG Calibration Studio Medical
The comparison table shows that the subject device (24HR513C) has the similar indications for usethe Secondary predicate device. Although the devices have some different technologicalcharacteristics (Power Consumption, Pixel Pitch, Resolution, horizontal/vertical frequency and

input/output 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/AMD2:2020
-Electromagnetic Compatibility Testing in accordance with EN 60601-1-2:2015(IEC 60601-1-2:2014)/ EN 60601-1-2:2015/A1:2021 (IEC 60601-1-2:2014/AMD1:2020)
-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+A2:2020

2) Software Validation

The software was designed and developed according to IEC 62304 software development process and was verified and validated. According to the guidance, we evaluated the level of Basic level documentation by identifying safety-related characteristics for device documentation level.

-The software information is provided in accordance with FDA guidance: Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff', issued on JUNE 2023.

3) Guidance

Display Devices for Diagnostic Radiology Guidance for Industry and Food and Drug Administration Staff, issued on SEPT 2022.

Measurements	Description	SE Note
a. Spatial resolution	Measurements of the transfer ofinformation from the image data tothe luminance fields at differentspatial frequencies of interesttypically done by reporting themodulation transfer function. Non-isotropic resolution properties shouldbe characterized properly byproviding two-dimensionalmeasurements or measurementsalong at least two representativeaxes.(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) ofpixel defects. This is typicallyprovided as a tolerance limit. Pixeldefects can interfere with the visibilityof small details in medical images.	Equivalent
c. Artifacts	Evaluate for image artifacts such asghosting and/or image sticking from	Same

According to the quidance, we test following performance items:

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Measurements	Description	SE Note
	displaying a fixed test pattern for a period of time.(Using 5x5 mosaic pattern, 64Gray / 127 Gray judgment)
d. Temporal response	Measurements of the temporal behavior of the display in responding to changes in image values from frame to frame. Since these transitions are typically not symmetric, rise and fall time constants are needed to characterize the system. Slow displays can alter details and contrast of the image when large image stacks are browsed or in video, panning, and zooming modes.	Equivalent
e. Luminance	Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values if the device is set to expand the range to the limit.	Same
f. 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
g. 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

According to the above test results, there are no significant performance differences between 24HR513C and the predicate devices that would adversely affect the use of the product. It has substantially equivalent performance compared to the predicate devices.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

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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 24HR513C 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).