21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) is intended to be used in displaying medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

Device Description

CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical display monitor (JVC KENWOOD Corporation's 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210)). This document details the device's technical specifications and compares it to a predicate device to establish substantial equivalence.

It's important to note that this document describes a display monitor, not an AI-powered diagnostic device or an algorithm that processes medical images. Therefore, many of the requested criteria (e.g., sample size, expert ground truth, MRMC studies, standalone performance) are not applicable or relevant to this type of device.

However, I can extract information related to its technical performance criteria and the justification for its equivalence.

Here's an analysis based on the provided text, focusing on the acceptance criteria for a medical display monitor, recognizing that it's not an AI/algorithm-based device:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (from "Technical Specification")	Reported Device Performance (from "Technical Specification" and "Substantial Equivalence Comparison")
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	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.)
Maximum Luminance (DICOM calibrated)	250 cd/m² DICOM calibrated (superior to predicate's 120 cd/m²)
Maximum Luminance (typ. As LCD component)	440 cd/m² typ. As LCD component (superior to predicate's 300 cd/m²)
Contrast Ratio	Typ 1500:1 (superior to predicate's 800:1)
DICOM GSDF Compliance	Displays images in accordance with DICOM GSDF by default utilizing factory calibrated display mode.
Safety and EMC Standards	Complies with 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).

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

Sample Size: Not applicable. This is a medical display monitor, and the "test set" refers to the individual unit or a small batch of units tested for compliance with performance specifications. It's not testing images or patient data.
Data Provenance: The testing appears to be internal by the manufacturer (JVC KENWOOD Corporation) and verified by third-party certifiers for safety and EMC standards. The origin of the actual "data" (e.g., luminance measurements) would be from the physical monitor itself during testing procedures.

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

Not applicable. The "ground truth" for a monitor's performance is established by objective physical measurements against established industry standards (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF). While trained engineers or technicians perform these tests, there isn't a concept of "expert ground truth" in the way it applies to diagnostic algorithms interpreting medical images.

4. Adjudication method for the test set:

Not applicable. Performance is based on direct measurement against predefined numerical specifications and visual inspection against criteria, not on expert adjudication of diagnostic outcomes.

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 is a display monitor, not an AI-powered diagnostic tool. MRMC studies are used to evaluate diagnostic imaging systems or AI algorithms, not passive display devices.

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

Not applicable. The device itself is a "standalone" display monitor, but it is not an algorithm, and it has no "human-in-the-loop" component in the sense of AI assistance for diagnosis. Its performance is measured as a standalone piece of hardware.

7. The type of ground truth used:

The "ground truth" for this device's performance is defined by established industry standards and specifications, such as:
- AAPM-TG18 (American Association of Physicists in Medicine Task Group 18) for display quality control.
- ISO13406-2 for pixel defects.
- DICOM GSDF (Grayscale Standard Display Function) for consistent grayscale reproduction.
- IEC 60601-1 for medical electrical equipment safety.
- FCC, MDD/CE, VCCI-B, ICES-003 for electromagnetic compatibility and other regulatory compliance.
Performance is confirmed through direct physical measurements of the monitor's characteristics (luminance, chromaticity, pixel defects) and visual inspections as per these standards.

8. The sample size for the training set:

Not applicable. This device does not use an "algorithm" derived from a training set. It's a hardware display whose performance is engineered and then verified.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it. The "ground truth" for the device's design and manufacturing is based on established engineering principles and medical display standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

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

May 27, 2015

JVC KENWOOD Corporation % Mr. Tsukasa Tashiro Engineering Specialist 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi 221-0022 JAPAN

Re: K151134

Trade/Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 28, 2015 Received: April 29, 2015

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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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

510(k) Number (if known) K151134

Device Name

21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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, Engineering SpecialistEmail: tashiro.tsukasa@jvckenwood.comTel: +81.258.24.6611Fax: +81.258.24.6617
Date Prepared:	April 28, 2015
Device Name:	21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210)
Common Name:	CCL210, CL21210
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:	CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitorwhose display resolution is 1600 x 1200 (landscape), 1200 x 1600(portrait) supporting DVI-I (both digital and analog interface) andDisplayPort (digital interface).
Intended Use:	21.3 inch (54 cm) Co lor 2M pixel LCD Monitor, CCL210(CL21210) is intended to be used in displayingand viewin gmedical images for diagnosis by trained medical practitioners. It isnot meant to be used in digital mammography.
Substantial Equivalence:	CCL210 (CL21210) shares the same technical characteristics,application and intended use with our predicate device CCL2 08(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)	CCL210 (CL21210)
510(k) Number	K092728	Not Known
Display Area	Horizontal: 408.0mm, Vertical: 306.0mm	Horizontal: 432.0mm, Vertical: 324.0mm
Input Signal	Mini D-sub 15-pin connector (same connector)DVI-I 29-pin connector	DVI-I 29-pin connector, DisplayPort connector
Maximum Resolution	1200 x 1600 at portrait display1600 x 1200 at landscape display	1200 x 1600 at portrait display1600 x 1200 at landscape display
Pixel Pitch	0.255 mm x 0.255mm	0.270 mm x 0.270 mm
Scanning Frequency	Horizontal: 30 – 75kHzVertical: 55 – 60Hz	Horizontal: 30 – 75kHzVertical: 55 – 60Hz
Maximum Image Clock	162MHz	162MHz
Maximum Luminance	120 cd/m² DICOM calibrated300 cd/m² typ. As LCD component	250 cd/m² DICOM calibrated440 cd/m² typ. As LCD component
Luminance Calibration(Optional)	SoftwarePhoto Sensor (optional): X-Rite Chroma 5	SoftwarePhoto Sensor (optional): X-Rite Chroma 5
Contrast Ratio	800:1	Typ 1500:1
Serial Communication	DDC-ci	USB
Safety Standards	Medical Safety: MET (for US)/MET-C (for Canada),IEC60601-1, IEC60601-1-2, IEC60950-1, FCVCCI-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)
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: 10.7kg473(w) x 476.4 – 537.9(H) x 220(D) mmPacked: 15.5kg470(w) x 675(H) x 347(D) mm
Power Supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz

bstantial Equivalence Compari

.210 (CL21210) employs a different LCD panel, power supply, and main board from predicate device CCL208 (K0927 ifferences:

CL210 (CL21210) employs the same tilt stand as that employed on the predicate device CCL208 (K09278). Th
zel and back enclosure of CCL210 (CL21210) are slightly larger but cl Similarities

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CCL210 (CL21210) can be considered to have equivalent display performances to those of the predicate device CCL208 (K092728) due to the following reasons:

a. The active area of CCL210 (CL21210) differs from that of the predicate device CCL208 (K092728) in size: 432.0mm x 324.0mm for CCL210 and 408.0mm x 305.0mm for the predicate device. Both devices, however, have the same maximum display resolution of 1600 x 1200.
b. The DICOM calibrated luminance value of the predicate device CCL208 (K092728) is 120cd/m2, whereas that of CCL210 (CL21210) is set to a higher value of 250cd/m2. In regard to the maximum luminance, CCL210 (CL21210) also achieves superior value of 400cd/m2 compared to the predicate device CCL208 (K092728) with 300cd/m2. Additionally CCL210 (CL21210) realizes high luminance at constantly stable level by adopting LED backlight, which lasts longer than conventional CCFL backlights do.
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), whereas CCL210 (CL21210) supports DVI-I (both digital and analog interface) and DisplayPort (digital interface).

As for the maintenance, the same QC software is used for both devices. Both devices have Backlight Sensor to stabilize the luminance.

The overall design of the CCL210 (CL21210) 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 CCL210 (CL21210) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

Conclusion

The 2M pixel Color LCD Monitor, CCL210 (CL21210) is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are the same to those of the predicate device and other differences have been independently validated. Any differences between the devices 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).