6M pixel 30.0 inch Color LCD Monitor CCL650i2 (CL30650. MD302C6) 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 mammography.

Device Description

CCL650i2 (CL30650, MD302C6) is a 6M 30.0-inch Color LCD monitor whose display resolution is 3280 x 2048 supporting DVI (digital visual interface) and DisplayPort.

AI/ML Overview

The provided text describes a 510(k) summary for a medical display monitor, the JVC KENWOOD 6M 30.0 inch Color LCD Monitor CCL650i2 (CL30650, MD302C6). The document aims to demonstrate substantial equivalence to a predicate device, the 21.3 inch (54 cm) Color LCD Monitor CCL358i2 (CL21358) (K133185).

However, the document does not contain information typically found in a study proving a device meets acceptance criteria for an AI/CADe medical device, but rather for a display monitor. Therefore, many of the requested fields regarding AI/CADe performance studies (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

The acceptance criteria described relate to the monitor's technical specifications and performance, demonstrating equivalency to a predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device's technical specifications and compares them to a predicate device to demonstrate substantial equivalence, rather than listing explicit "acceptance criteria" against which performance is measured in a quantitative study with pass/fail metrics. However, based on the "Technical Specification" and "Substantial Equivalence Comparison" sections, the following can be inferred as performance aspects that needed to be met or shown as equivalent/superior to the predicate:

Acceptance Criteria (Inferred from Technical Specifications & Equivalence)	Reported Device Performance (CCL650i2)
Luminance Uniformity	Less than 30% based on AAPM-TG18 4.4. (Note: "Refer to actual Luminance uniformity data" implies this was tested and met, but the specific 'actual data' is not provided in this summary.)
Pixel Defects / Fault	Class II or more (ISO13406-2). (Note: "Refer to actual data" implies this was tested and met, but specific 'actual data' is not provided in this summary.)
Artifacts (pixel defects/faults, ringing, ghosting, image sticking)	Not explicitly quantified, but adherence to ISO13406-2 for pixel defects is mentioned. The general conclusion states "None of the tests revealed behaviors inconsistent with the expected performance."
Chromaticity Measurement (5%, 50%, 95% Level)	Not explicitly quantified, but "Refer to actual data" implies this was tested and met.
Chromaticity (Delta (u', v'))	≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. (Note: "Refer to actual chromaticity data" implies this was tested and met, but specific 'actual data' is not provided in this summary.)
Maximum Display Resolution	3280 x 2048 dots (twice or more larger than predicate's 1536 x 2048).
Active Display Area	Horizontal: 645.504mm, Vertical: 403.0464mm (larger than predicate).
DICOM Calibrated Luminance	410 cd/m² (same as predicate).
Typical Maximum Luminance	800 cd/m² (same as predicate).
Backlight Type	LED (same as predicate, considered beneficial due to mercury-free, less power, slower deterioration).
DICOM GSDF Compliance	Images displayed in accordance with DICOM GSDF by default utilizing factory calibrated display mode (same as predicate).
Input Signal Support	DVI and DisplayPort (same as predicate).
Pixel Pitch	0.197 x 0.197mm (smaller than predicate's 0.2115 x 0.2115mm, indicating finer display).
Safety and EMC Standards Compliance	Validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers (ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC Class B, MDD/CE, VCCI-B Class B, same as predicate). JVC KENWOOD Corporation performed additional system and performance tests, with no inconsistent behaviors found.
Calibration Software and Sensor	Software: Medivisor Nx, Calibration Sensor: Chroma5 (X-Rite) (same as predicate).
Built-in Sensors	Front Sensor and Ambient Light Sensor (same as predicate, with front sensor enabling automatic grayscale calibration).

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

This information is not applicable as this is a medical display device, not an AI/CADe system processing medical images for diagnostic tasks using a test set of patient data. The "tests" performed relate to the monitor's physical performance characteristics and compliance with technical standards.

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

This information is not applicable for a medical display device. The "ground truth" here refers to the physical and electrical characteristics of the monitor meeting specified technical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for a medical display device.

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

This information is not applicable as this is a medical display device, not an AI-assisted diagnostic tool.

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

This information is not applicable as this is a medical display device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to established technical specifications and international standards (e.g., AAPM-TG18, ISO13406-2, ANSI/AAMI ES60601-1, FCC, etc.) that the monitor's performance characteristics must meet.

8. The sample size for the training set

This information is not applicable for a medical display device.

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

This information is not applicable for a medical display device.

Summary

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FEB 1 9 2014

TOTOKU

K140214
Page 1 of 5

510(k) SUMMARY

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:	January 20, 2014
Device Name:	6M 30.0 inch Color LCD Monitor CCL650i2 (CL30650, MD302C6)
Common Name:	CCL650i2, CL30650, MD302C6
Classification Name:	Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System)
Predicate Device:	21.3 inch (54 cm) Color LCD Monitor CCL358i2 (CL21358)(K133185)
Device Description:	CCL650i2 (CL30650, MD302C6) is a 6M 30.0-inch Color LCDmonitor whose display resolution is 3280 x 2048 supporting DVI(digital visual interface) and DisplayPort.
Intended Use:	6M pixel 30.0 inch Color LCD Monitor, CCL650i2 (CL30650,MD302C6) is intended to be used in displaying and viewingmedical images for diagnosis by trained medical practitioners. It isnot meant to be used for digital mammography.
Substantial Equivalence:	CCL650i2 (CL30650, MD302C6) realizes 2 (two) 3M screens of thepredicate device CCL358i2 (CL21358) (K133185) in one device.The characteristics of CCL650i2 (CL30650, MD302C6) achievesmore than that of 2 (two) 3M monitors, CL358i2 (CL21258)(K133185). The both devices do not share common components.

JVC KENWOOD Corporation

Professional & Healthcare Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan

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Technical Specification

Luminance uniformity: [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data 2. Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2 3. Artifacts • pixel defects/faults (ISO13406-2): · artifacts: miscellaneous including ringing, ghosting, image sticking 4. Chromaticity Measurement of 5%, 50%, 95% Level
[SPEC] Refer to actual data. 5. Chromaticity [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 Refer to actual chromaticity data.

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	CCL35812 (CL21358)	CCL650i2 (CL30650, MD302C6)
510(k) Number	K133185	Unknown
Display Area	Horizontal: 433.152mm, Vertical: 324.864mm	Horizontal: 645.504mm, Vertical: 403.0464mm
Input Signal	DVI-D Digital Video Signal, DisplayPort	DVI-D Digital Video Signal, DisplayPort
Maximum Display	1536 x 2048 dots	3280 x 2048 dots
Pixel Pitch	0.2115 x 0.2115mm	0.197 x 0.197mm
	DVI	DVI/DisplayPort
Scanning Frequency	46.6KHz, Vertical: 30Hz (Landscape)61.9KHz, Vertical: 30Hz (Portrait)93.1KHz, Vertical: 60Hz (Landscape)123.9KHz, Vertical: 60Hz (Portrait)DisplayPort47.4KHz, Vertical: 30Hz (Landscape)63.2KHz, Vertical: 30Hz (Portrait)94.8KHz, Vertical: 60Hz (Landscape)126.3KHz, Vertical: 60Hz (Portrait)	126.5KHz, Vertical: 60Hz (3M) 1123.8KHz, Vertical: 60Hz (3M PLUS) 263.2KHz, Vertical: 30Hz (6M) 361.9KHz, Vertical: 30Hz (6M PLUS) 41 3M=1536 x 20482 3M PLUS=1640 x 20483 6M=3072 x 20484 6M PLUS=3280 x 2048
Maximum Luminance	410 cd/m² DICOM calibrated800 cd/m² typ.as LCD component	410 cd/m² DICOM calibrated800 cd/m² typ.as LCD component
Luminance Calibration(Optional)	Software: Medivisor NxCalibration Sensor: Chroma5 (X-Rite)	Software: Medivisor NxCalibration Sensor: Chroma5 (X-Rite)
Contrast Ratio	1400:1	1000:1
Serial Communication	USB: upstream port (x 1), downstream port (x 2)	USB: upstream port (x 1), downstream port (x 2)
Safety Standards	ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, 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 340(D) mm	Net: 15.5kg695.6(w) x 512.1 - 573.6(H) x 243.5(D) mmPacked: 20.3kg791(w) x 690(H) x 344(D) mm
Power Supply	100-240V AC 50/60Hz	100-240V AC 50/60Hz

ubstantial Equivalence Compariso

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CCL650i2 (CL30650, MD302C6) can be considered to have equivalent display performances to those of the predicate device CCL358) (K133185) due to the following reasons:

a. The maximum display size (3280 x 2048) is twice or more larger than that of the predicate device (1536 x 2048) and the active area size (645.504mm (H) x 403.0464mm (V)) is larger than that of the predicate device (433.152mm (H) x 324.864mm (V)). The proposed 6M device realizes two 3M screens in one device.
b. The DICOM calibrated luminance values of the both devices are the same (410 cd/m² and the typical maximum luminance values are also same (800 cd/m²) between the both devices. 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 is employed with both CCL650i2 (CL30650, MD302C6) and the predicate device CCL358i2 (CL21358) (K133185) because it is mercury-free, consumes less power and deteriorates 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.
Pixel pitch of CCL650i2 (CL30650, MD302C6) 0.197mm x 0.197mm is smaller than that f. of the oredicate device CCL358i2 (CL21358) (K133185) 0.2115mm x 0.2115mm. The proposed device can display image more finely than the predicate device.
g. CCL650i2 (CL30650, MD302C6) can display in 6 modes: 1) Full DVI (6M) 3280 x 2048 (30Hz) 2) Input 1: DVI (3M) 1640 x 2048 (60Hz), Input 2: DVI (3M) 1640 x 2048 (60Hz) 3) Input 1: DVI (3M) 1640 x 2048 (60Hz), Input 2: DP (3M) 1640 x 2048 (60Hz) 4) Input 1: DP (3M) 1640 x 2048 (60Hz), Input 2: DVI (3M) 1640 x 2048 (60Hz) 5) Input 1: DP (3M) 1640 x 2048 (60Hz), Input 2: DP (3M) 1640 x 2048 (60Hz) 6) Full DP (6M) 3280 x 2048 (30Hz) This unique characteristics is only for the proposed device.

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 Ix. 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" in "Application".

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K140214
Page 5 of 5

The overall design of the CCL650i2 (CL30650, MD302C6) has been 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 CCL650i2 (CL30650, MD302C6) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

Conclusion

The 6M pixel Color LCD Monitor, CCL650i2 (CL30650, MD302C6) is substantially equivalent to 2 (two) of the predicate 3M device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are not the same to those of the predicate device, but the proposed device has been accepted by the same Safety Standards of the predicate device and the differences have been independently validated. Any differences between the devices do not affect safety or effectiveness. Therefore, the proposed device CCL650i2 (CL30650, MD302C6) were determined to be substantially equivalent to the predicate device CCL358i2 (CL21358) (K133185).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993.0002

February 19. 2014

JVC KENWOOD Corporation % Mr. Tsukasa Tashiro General Manager 3-12. Moriya-Cho. Kanagawa-Ku Yokohama-Shi. Kanagawa 221-0022 JAPAN

Re: K140214

Trade/Device Name: 6M 30.0 inch Color I.CD Monitor CCL650i2 (C1.30650, MD302C6) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ. Dated: January 21, 2014 Received: January 28, 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. Iisting 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.fda.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/Salctv/ReportalProblem/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 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: January 31, 2017
See PRA Statement on last page.

510(k) Number (if known)	K140214
Not known

Device Name
CCI.650i2 (CI.30650, MD302C6)

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (C

Sm.h.7)

FORM FDA 3881 (1/14)

Page of of

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).