24.1 inch (61.1 cm) Color 2M pixel LCD Monitor CCL244 (CL24244) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.

Device Description

CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitor whose display resolution is 1920 x 1200 (landscape), 1200 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.

AI/ML Overview

This document is a 510(k) premarket notification for a medical display monitor, the JVC KENWOOD CORPORATION's 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244). The information provided focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance or AI-related metrics. Therefore, many of the requested elements are not applicable or cannot be extracted from this type of document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly frame these as "acceptance criteria" and "reported device performance" in a structured table for clinical decision-making metrics. Instead, it lists technical specifications and performance characteristics tested for the device. The "SPEC" column below is derived from the "Technical Specification" section on page 6, and "Reported Device Performance" is inferred from statements like "Refer to actual data" or comparisons to the predicate.

Acceptance Criteria (from "Technical Specification")	Reported Device Performance (as inferred)
1. Luminance uniformity [SPEC] Less than 30% based on AAPM-TG18 4.4.	Reported: "Refer to actual Luminance uniformity data" (Implies data was collected and met the spec, but numerical performance is not detailed in this document). The device is stated to have "equivalent or superior capability in stabilizing luminance" to the predicate.
2. Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2	Reported: Performance meets or exceeds Class II (ISO13406-2). (No specific numerical defect count is provided, but meeting the class implies performance within the standard).
3. Artifacts (phase/clock issues flicker, miscellaneous including ringing, ghosting, image sticking) [SPEC] By visible check, no flicker, ringing, ghosting and image sticking	Reported: "By visible check, no flicker, ringing, ghosting and image sticking" (Directly states it meets the criteria by visual inspection). No specific metrics are given for "reported device performance" beyond this qualitative statement.
4. Chromaticity Measurement of 5%, 50%, 95% Level [SPEC] Refer to actual data.	Reported: "Refer to actual data." (Implies data was collected, but not provided in this document).
5. Chromaticity [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4	Reported: "Refer to Chromaticity actual data." (Implies data was collected and met the spec, but numerical performance is not detailed in this document). The device is stated to have "equivalent display performances" to the predicate, and both display images "in accordance with DICOM GSDF."
6. Power On Luminance Drift [SPEC] Refer to actual data.	Reported: "Refer to actual data." (Implies data was collected, but not provided in this document). The device "achieves equivalent or superior capability in stabilizing luminance to that of the predicate device."
Other relevant performance points mentioned:	Reported: - Maximum Luminance: Both devices have 300 cd/m². The proposed device's DICOM calibrated luminance is 200 cd/m² (higher than predicate's 120 cd/m²). - Backlight: LED backlight used, which "lasts longer than the conventional CCFL's" and "consumes less power and deteriorates more slowly." No adverse effects on image quality from LED backlight recognized.
Safety and EMC Standards	The device was "validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers." Specific standards listed for CCL244: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 (Class B), CCC.

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

This document describes a medical display monitor, not an AI or diagnostic algorithm. Performance evaluation for a monitor primarily involves testing the physical display unit(s) against technical specifications. Therefore, the concept of a "test set" and "data provenance" as typically used for AI or diagnostic studies (e.g., patient cases, retrospective/prospective data) does not apply here. The tests would be performed on the manufactured device models.

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

Again, for a medical display monitor, the "ground truth" is typically objective physical measurements and adherence to technical standards. There isn't a "ground truth" established by medical experts in the context of clinical interpretation for this device. Calibration against standards like AAPM-TG18 would be performed using specialized equipment and trained technicians, not radiologists establishing clinical ground truth.

4. Adjudication method for the test set:

Not applicable. This is not a study involving human interpretation of medical images where adjudication methods like "2+1" or "3+1" would be used. Device performance is determined by objective technical measurements.

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. This device is a display monitor, not an AI-powered diagnostic tool. No MRMC study or AI-assistance evaluation was conducted or is relevant for this product.

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

Not applicable. This is a hardware device (display monitor), not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance relies on objective technical specifications and internationally recognized standards. For example:

Luminance uniformity, chromaticity, power-on luminance drift: Measured against quantitative specifications derived from standards like AAPM-TG18.
Pixel defects: Assessed against ISO13406-2 standard for LCD pixel defects.
Artifacts: Assessed by visual inspection against qualitative criteria of "no flicker, ringing, ghosting, image sticking."
Safety and EMC: Assessed by compliance with relevant international standards (e.g., IEC60601-1, ANSI/AAMI ES60601-1, FCC Class B).

8. The sample size for the training set:

Not applicable. This device is a hardware display monitor and does not involve AI or machine learning models that require a "training set."

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

Not applicable for the reason stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

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

October 3, 2014

JVC KENWOOD CORPORATION

% Mr. Tsukasa Tashiro Senior Manager 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa, 221-0022 JAPAN

Re: K142540

Trade/Device Name: 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: September 5, 2014 Received: September 9, 2014

Dear Mr. Tashiro:

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.

Sm.f.f)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) Not known K142540

Device Name CCL244 (CL24244)

Indications for Use (Describe)

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

区 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)

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TOTOKU

510(k) SUMMARY

Submitted Information:	JVC KENWOOD CORPORATION3-12, MORIYA-CHO, KANAGAWA-KU,YOKOHAMA-SHI, KANAGAWA, 221-0022 JAPAN
Contact Person:	Tsukasa Tashiro, Senior ManagerEmail: tashiro.tsukasa@jvckenwood.comTel: +81.258.24.6611Fax: +81.258.24.6617
Date Prepared:	September 5, 2014
Device Name:	24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
Common Name:	CCL244, CL24244
Classification Name:	Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System)
Predicate Device:	20.1 inch (51 cm) Color LCD Monitor CCL208 (CDL2013A)(K092728).
Device Description:	CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitorwhose display resolution is 1920 x 1200 (landscape), 1200 x 1920(portrait) supporting multiple interfaces such as HDMI, BNC,S-video and HD-SDI in addition to DVI and D-Sub.
Intended Use:	24.1-inch (61.1 cm) Color 2M pixel LCD Monitor, CCL244(CL24244) is intended to be used in displaying and viewingmedical images from PACS, endoscope and ultrasonograph fordiagnosis by trained Medical practitioners. It is not meant to beused in digital mammography.
Substantial Equivalence:	CCL244 (CL24244) shares the same technical characteristics andapplication with our predicate device CCL208 (K092728).

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Technical Specification

1. Luminance uniformity [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data
1. Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2
1. Artifacts
- phase/clock issues flicker
- · miscellaneous including ringing, ghosting, image sticking [SPEC] By visible check, no flicker, ringing, ghosting and image sticking
1. Chromaticity Measurement of 5%, 50%, 95% Level [SPEC] Refer to actual data.
1. Chromaticity

[SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 Refer to Chromaticity actual data

1. Power On Luminance Drift [SPEC] Refer to actual data.

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	CCL208 (CDL2013A)	CCL244 (CL24244)
510(k) Number	K092728	Not Known
Display Area	Horizontal: 408.0mm, Vertical: 306.0mm	Horizontal: 518.0mm, Vertical: 324.0mm
Input Signal	Mini D-sub 15-pin connector (same connector)DVI-I 29-pin connector	Mini D-sub 15-pin connector (same connector)DVI-I 24-pin connector, HDMI connector, BNC connector,S-Video connector, HD-SDI connector
Maximum Resolution	1200 x 1600 at portrait display1600 x 1200 at landscape display	1920 x 1200 at landscape display1200 x 1920 at portrait display
Scanning Frequency	Horizontal: 30 - 75kHzVertical: 55 - 60Hz	Horizontal: 30 - 80kHzVertical: 50 - 85Hz
Maximum Image Clock	162MHz	162MHz
Maximum Luminance	300cd/m²	300cd/m²
Luminance Calibration (Optional)	SoftwarePhoto Sensor (optional): X-Rite Chroma 5	SoftwarePhoto Sensor (optional): X-Rite Chroma 5
Serial Communication	DDC-ci based serial communication	RS-232C based serial communication (D-sub 9-pin)
Safety Standards	Medical Safety: MET (for US)/MET-C (for Canada),IEC60601-1, IEC60601-1-2, IEC60950-1, FCC-B,VCCI-B, MDD/CE	Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003(Class B), CCC
Weight & Dimension	Net: 10.7kg453(w) x 462 - 523(H) x 220(D) mmPacked: 15.5kg470(w) x 685(H) x 345(D) mm	Net: 7.1kg560.2(w) x 363.8(H) x 100(D) mmPacked: 9.2kg240(w) x 470(H) x 685(D) mm
Power Supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz

ubstantial Equivalence Compariso

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CCL244 (CL24244) can be considered to have equivalent display performances to those of the predicate device CCL208 (K092728) due to the following reasons:

a. CCL244 (CL24244) comes with a wider screen of 518mm x 324mm sized active display area with 19201200 sized maximum display compared to the predicate device CCL208 (K092728) with 408.0mm x 306.0mm active area and 16001200 sized maximum display.
b. The DICOM calibrated luminance value of the predicate device CCL208 (K092728) is 120cd/m2, whereas that of CCL244 (CL24244) is set to a higher value of 200cd/m2. Both devices have 300cd/m2 for the highest luminance value. Moreover, by adopting LED backlighting system which lasts longer than the conventional CCFL's, CCL244 (CL24244) becomes capable of maintaining the brightness at the higher DICOM-calibrated luminance value for the same backlight life time as or even longer than the predicate device.
c. The LED backlight was newly employed instead of CCFL backlight because it is mercury-free, consumes less power and deteriorates more slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to "Technical Data" where several image quality characteristics of the proposed device are compared with those of the predicate device.
d. The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated display mode stored in lookup tables inside of them.
e. The predicate device CCL208 (K092728) supports DVI-D (digital interface) and D-Sub (analog interface), while CCL244 (CL24244) is compatible with multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.

As for the maintenance, QA software is used for both devices. Adopting the LED current stabilization circuit for luminance stabilization, CCL244(CL24244) achieves equivalent or superior capability in stabilizing luminance to that of the predicate device CCL208 (K092728).

The overall design of the CCL244 (CL24244) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL244 (CL24244) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

Conclusion

The 2M pixel Color LCD Monitor, CCL244 (CL24244) is substantially equivalent to the predicate device with respect to technical characteristics and application. In terms of the intended use, the proposed device can be used for displaying medical images through endoscope and ultrasonograph besides PACS. The specifications of the primary component employed by the proposed device are the same to those of the predicate device and do not affect safety or effectiveness.

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).