21.5 inch (54.5 cm) Color 2M pixel LCD Monitor CCL220 (CL2220) 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

CCL220 (CL22220) is a 21.5-inch (54.5 cm) Color LCD monitor whose display resolution is 1920 x 1080 (landscape), 1080 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 describes a 510(k) premarket notification for a medical display monitor, the JVC KENWOOD CCL220 (CL2220). As such, the study described focuses on demonstrating substantial equivalence to a predicate device, rather than on proving performance against clinical endpoints using a traditional clinical trial design with patient data.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Technical Specification" as desired criteria (implicitly, acceptance criteria based on industry standards and performance of the predicate device). The performance is largely reported as "Refer to actual data" or a statement of meeting the specification.

Acceptance Criteria (Technical Specification)	Reported Device Performance
1. Luminance uniformity	Less than 30% based on AAPM-TG18 4.4. (Refer to actual Luminance uniformity data)
2. Pixel Defects / Fault	Class II or more. ISO13406-2
3. Artifacts (phase/clock issues, flicker, miscellaneous including ringing, ghosting, image sticking)	By visible check, no flicker, ringing, ghosting, and image sticking
4. Chromaticity Measurement of 5%, 50%, 95% Level	Refer to actual data.
5. Chromaticity	Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. (Refer to Chromaticity actual data)
6. Power On Luminance Drift	Refer to actual data.

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

Sample Size for Test Set: Not explicitly stated as a number of monitors tested. The document refers to testing "the CCL220 (CL2220)" in general, implying at least one unit of the device was subjected to these tests.
Data Provenance: The tests were performed by JVC KENWOOD Corporation as part of their validation process. The "Technical Data" mentioned in section {7} would likely contain the raw data for these tests. The country of origin of the device manufacturer is Japan. The testing is prospective for the purposes of this 510(k) submission, as it was conducted to demonstrate the device's performance.

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

Number of Experts: Not applicable in the traditional sense of medical image interpretation. The "ground truth" for these technical specifications is defined by industry standards (e.g., AAPM-TG18, ISO13406-2) and the technical capabilities of the device itself.
Qualifications of Experts: The validation was performed by JVC KENWOOD Corporation's engineering and quality assurance teams. While specific qualifications are not listed, it's implied they have the technical expertise to perform these measurements and ensure compliance with the stated standards.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The tests involve objective measurements against predefined technical specifications.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a display monitor, not an AI-powered diagnostic tool. The document compares the new device (CCL220) to a predicate device (CCL208) on technical specifications, not on clinical effectiveness with human readers.

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

Standalone Performance: Not applicable. This is a medical display device, not an algorithm. Its "performance" is based on its ability to accurately and consistently display images according to technical standards.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for these technical tests is primarily defined by:
- Industry Standards: Such as AAPM-TG18 (for luminance uniformity, chromaticity) and ISO13406-2 (for pixel defects).
- Manufacturer Specifications: The inherent design and expected performance characteristics of the display.
- Objective Measurements: Using calibrated equipment to measure luminosity, chromaticity, etc.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. As this device is a hardware display monitor, there is no "training set" in the context of machine learning or AI models. The development and calibration would involve engineering processes and manufacturing tolerances.

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

Ground Truth for Training Set: Not applicable. No training set is used for this type of device. The monitor is designed and manufactured to meet specific technical performance benchmarks.

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: K142536

Trade/Device Name: 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) 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. 7)

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 K142536

Device Name CCL220 (CL2220)

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:	21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
Common Name:	CCL220, CL22220
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:	CCL220 (CL22220) is a 21.5-inch (54.5 cm) Color LCD monitorwhose display resolution is 1920 x 1080 (landscape), 1080 x 1920(portrait) supporting multiple interfaces such as HDMI, BNC,S-video and HD-SDI in addition to DVI and D-Sub.
Intended Use:	21.5 inch (54.5 cm) Color 2M pixel LCD Monitor, CCL220(CL22220) 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:	CCL220 (CL22220) 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)	CCL220 (CL22220)
510(k) Number	K092728	Not Known
Display Area	Horizontal: 408.0mm, Vertical: 306.0mm	Horizontal: 475.2mm, Vertical: 267.3mm
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	1080 x 1920 at portrait display1920 x 1080 at landscape display
Scanning Frequency	Horizontal: 30 - 75kHzVertical: 55 - 60Hz	Horizontal: 30 - 91kHzVertical: 50 - 85Hz
Maximum Image Clock	162MHz	162MHz
Maximum Luminance	300cd/m²	250cd/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: 5.1kg513.4(w) x 305.8(H) x 74.3(D) mmPacked: 6.7kg158(w) x 481(H) x 622(D) mm
Power Supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz

ubstantial Equivalence Compariso

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CCL220 (CL2220) can be considered to have equivalent display performances to those of the predicate device CCL208 (K092728) due to the following reasons:

a. CCL220 (CL22220) comes in a wider screen of 475.2mm sized active display area with 19201080 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 CCL220 (CL22220) is set to a higher value of 150cd/m2. In relation to the maximum luminance of the display, the proposed device CCL220 (CL22220) has the lower value of 250cd/m2 compared to the predicate device CCL208 (K092728) with 300cd/m2. However, CCL220 (CL22220) 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. This is achieved by adopting LED backlighting system, which lasts longer than the conventional CCFL's.
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 (digital interface) and D-Sub (analog interface), while CCL220 (CL22220) 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, CCL220 (CL2220) achieves equivalent or superior capability in stabilizing luminance to that of the predicate device CCL208 (K092728).

The overall design of the CCL220 (CL22220) 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 CCL220 (CL2220) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

Conclusion

The 2M pixel Color LCD Monitor, CCL220 (CL22220) 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 as 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).