21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL258i2 (CL21258) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

Device Description

CCL258i2 (CL21258) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.

AI/ML Overview

The provided text describes the JVC KENWOOD CORPORATION's 21.3 inch (54 cm) Color LCD Monitor CCL258i2 (CL21258). The document is a 510(k) summary, primarily focused on demonstrating substantial equivalence to a predicate device (CCL256i2). It outlines the device's technical specifications and intended use.

Here's an analysis of the acceptance criteria and study information based only on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (SPEC)	Reported Device Performance (CCL258i2)
Luminance uniformity: Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data	Not explicitly stated as a numerical value for CCL258i2. The document states: "The high luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights." and "Refer to 'Technical Data' where several image quality characteristics of the proposed device are compared with those of the predicate device." It implies uniformity is addressed through the new backlight technology but doesn't give a specific pass/fail for CCL258i2.
Pixel Defects / Fault: Class II or more. ISO13406-2	Not explicitly stated as a numerical value or pass/fail statement for CCL258i2.
Artifacts: • phase/clock issues flicker • miscellaneous including ringing, ghosting, image sticking. By visible check, no flicker, ringing, ghosting and image sticking	Not explicitly stated as a numerical value or pass/fail statement for CCL258i2. The document states: "None of the tests revealed behaviors inconsistent with the expected performance." which would cover this criterion.
Chromaticity Measurement of 5%, 50%, 95% Level: data	Not explicitly stated as a numerical value or pass/fail statement for CCL258i2. The document refers to "Chromaticity actual data."
Chromaticity: Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. Refer to Chromaticity actual data	Not explicitly stated as a numerical value or pass/fail statement for CCL258i2. The document refers to "Chromaticity actual data."
Maximum Luminance (DICOM calibrated)	410 cd/m² DICOM calibrated (Same as predicate device)
Maximum Luminance (typ. as LCD component)	900 cd/m² typ. as LCD component (Lower than predicate device's 950 cd/m²)
Contrast Ratio	1400:1 (Higher than predicate device's 900:1)
DICOM GSDF compliance	Devices display images in accordance with DICOM GSDF by default utilizing factory calibrated display mode (Implied full compliance).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of a clinical study or image dataset. The testing conducted appears to be primarily engineering verification and validation of the device's physical and display characteristics.

Sample Size: Not applicable in the context of a traditional medical device study with a specific dataset of images. The tests appear to have been performed on the device itself.
Data Provenance: Not applicable. The "study" here is a technical performance verification of the LCD monitor.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided because the "study" is a technical performance verification of an LCD monitor, not an AI or diagnostic device that requires expert-established ground truth for a test set of medical images. The acceptance criteria relate to physical display characteristics.

4. Adjudication Method for the Test Set

This information is not provided, as it is not relevant to the technical performance verification of an LCD monitor.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic algorithms or devices that radiologists interact with to assess diagnostic performance. The CCL258i2 is an LCD monitor for displaying images, not a diagnostic algorithm itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone evaluation was not done. The device is an LCD monitor, not an algorithm. The testing described focuses on its display capabilities and compliance with technical standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance verification would be established against technical standards and specifications (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF), not medical image outcomes or pathology reports. The reference to "actual Luminance uniformity data" and "Chromaticity actual data" suggests measurements were taken against these technical standards.

8. The Sample Size for the Training Set

Not applicable. The device is an LCD monitor; there is no AI algorithm being trained.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI algorithm being trained, therefore no training set or associated ground truth.

Summary of the Study and Conclusion from the Document:

The "study" described in the 510(k) summary is a technical verification and validation of the CCL258i2 Color LCD Monitor to demonstrate its substantial equivalence to the predicate device (CCL256i2). The manufacturer performed a range of system and performance tests to ensure the device meets its specifications and complies with internationally recognized safety and EMC standards. Key areas of comparison included display characteristics like maximum display size, active area, DICOM calibrated luminance, maximum typical luminance, contrast ratio, input signals, and compliance with DICOM GSDF.

The conclusion is that the CCL258i2 is substantially equivalent to the predicate device regarding technical characteristics, application, and intended use. The differences (LCD panel and power supply) were validated, and the manufacturer determined they do not affect safety or effectiveness. The employment of LED backlight in the new device is cited as an improvement for maintaining high luminance consistently due to slower deterioration.

Summary

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TOTOKU

K133181
Page 1 of 4

510(k) SUMMARY

DEC 0 3 2013

Submitted Information:	JVC KENWOOD CORPORATION3-12, MORIYA-CHO, KANAGAWA-KU,YOKOHAMA-SHI, KANAGAWA, 221-0022 JAPAN
Contact Person:	Tsukasa Tashiro, General ManagerEmail: tashiro.tsukasa@jvckenwood.comTel: +81.258.24.6611Fax: +81.258.24.6617
Date Prepared:	October 4, 2013
Device Name:	21.3 inch (54 cm) Color LCD Monitor CCL258i2 (CL21258)
Common Name:	CCL258i2, CL21258
Classification Name:	Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System)
Predicate Device:	21.3 inch (54 cm) Col or LCD Monitor CCL25 6i2 (CL21256)(K113136)
Device Description:	CCL258i2 (CL21258) is a 21.3-inch (54 cm) Color LCD monitorwhose display resolution is 1200 x 1600 (landscape), 1600 x 1200(portrait) supporting DVI (digital visual interface) and Display Port.
Intended Use:	21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL258i2 (CL21258)is intended to be used in displaying and viewing medical imagesfor diagnosis by trained medical practitioners. It is not meant to beused for digital mammography.
Substantial Equivalence:	CCL258i2 (CL21258) shares the same characteristics with ourpredicate device CCL256i2 (K113136) except for the LCD paneland power supply.

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

・

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Substantial Equivalence Comparison

510(k) Number	CCL256i2 (CL21256)	CCL258i2 (CL21258)
Display Area	K113136Horizontal: 432.0mm, Vertical: 324.0mm	K133181Horizontal: 432.0mm, Vertical: 324.0mm
Input Signal	DVI-D Digital Video Signal, DisplayPort	DVI-D Digital Video Signal, DisplayPort
Maximum Display	1200 x 1600 dots	1200 x 1600 dots
Pixel Pitch	0.270 x 0.270 mm	0.270 x 0.270 mm


Scanning Frequency	DVI74.1KHz, Vertical: 60Hz (Landscape)98.1KHz, Vertical: 60Hz (Portrait)DisplayPort75.0KHz, Vertical: 60Hz (Landscape)99.0KHz, Vertical: 60Hz (Portrait)	DVI74.1KHz, Vertical: 60Hz (Landscape)98.1KHz, Vertical: 60Hz (Portrait)DisplayPort75.0KHz, Vertical: 60Hz (Landscape)99.0KHz, Vertical: 60Hz (Portrait)
Maximum Luminance	410 cd/m² DICOM calibrated950 cd/m² typ.as LCD component	410 cd/m² DICOM calibrated900 cd/m² typ.as LCD component
Luminance Calibration(Optional)	Software: Medivisor NxCalibration Sensor (Optional): Chroma5 (X-Rite)	Software: Medivisor NxCalibration Sensor (Optional): Chroma5 (X-Rite)
Contrast Ratio	900:1	1400:1
Serial Communication	USB: upstream port (x 1), downstream port (x 2)	USB: upstream port (x 1), downstream port (x 2)
Safety Standards	Medical: UL60601-1, CSA C22.2 No.601.1, FCC (Class B),MDD/CE, VCCI-B (Class B)	ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B)
Weight & Dimension	Net: 12kg474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape)367(w) x 521.9 - 583.4(H) x 220(D) mm (Portrait)Packed: 15.0kg470(w) x 670(H) x 345(D) mm	Net: 12kg474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape)367(w) x 521.9 - 583.4(H) x 220(D) mm (Portrait)Packed: 15.0kg470(w) x 670(H) x 345(D) mm
Power Supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz

Samples

Similarities:
CCL258i2 (CL21258) employs the same front bezel, back enclosure and tilt stand as predicate device CCL256i2 (K113136)
Differences

Differences:

Differences:
CCL258i2 (CL21258) employs a different LCD panel and power supply.

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KB33181
page 4 of 4

CCL258i2 (CL21258) can be considered to have equivalent display performances to those of the predicate device CCL256i2 (K113136) due to the following reasons:

a. The maximum display sizes (1600*1200) and the active area sizes (432.0mm (H) x 324.0mm (V)) used for the both devices are the same.
b. The DICOM calibrated luminance values of the both devices are the same (410 cd/m2) though the typical maximum luminance value (900 cd/m2) is lower than that of the predicate device (950 cd/m2). The high luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
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. Both devices support Digital Visual Interface (DVI) and DisplayPort.

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

As for built-in sensors, both devices have 2 (two) kinds of common sensors, Front Sensor and Ambient Light Sensor. Front Sensor is related to the maintenance or calibration and Ambient Light Sensor is used to measure the ambient light by lx. Front sensor enables automatic grayscale calibration by measuring the luminance at the screen surface. Without Front sensor, the grayscale calibration process requires human intervention and the use of and external sensor. The accuracy data of the calibration with external sensors and that with Front Sensor is included in section 9 "Verification & Validation" in "Application".

The overall design of the CCL258i2 (CL21258) 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 CCL258i2 (CL21258) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

Conclusion

The 2M pixel Color LCD Monitor, CCL258i2 (CL21258) 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three wing-like shapes.

Public Health Service

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

December 3, 2013

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

Re: K133181

Trade/Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL258i2 (CL21258) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 4, 2013 Received: October 17, 2013

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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Page 2-Mr. Tashiro

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.h.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: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) KI33181

Device Name CCL258i2 (CL21258)

Indications for Use (Describe)

21.3 inch (54 cm) Color 2M pixel 1.CD Monitor CC1.258) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital manmography.

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

[図] 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)

FORM FDA 3881 (9/13)

PSC Publicions Service (114) ; d 1-47 41 EF

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).