21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCD Monitor CCL550i2 (CL21550) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

Device Description

CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

AI/ML Overview

The provided text describes the JVC KENWOOD Corporation's 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2 (CL21550) and its substantial equivalence to a predicate device. This document is a 510(k) premarket notification to the FDA. It does not describe a study involving human readers or AI, but rather the technical specifications and testing of a medical display monitor.

Therefore, many of the requested items related to clinical studies, human experts, and AI effectiveness are not applicable to the provided document. The information available focuses on engineering specifications and direct performance measurements of the display device.

Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" or "Not Provided" where the information cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (SPEC)	Reported Device Performance
Declared array size (spec): 422.4(H)mm x 337.92(V) mm	Actual array size (measured): 422.7(H)mm x 338.0(V)mm
Luminance Max (Lmax)=1000cd/m², Luminance Min (typ) = 0.77cd/m² at Lmax=1000cd/m²	Min.700cd/m² Typ. 1000cd/m² (as LCD component), 500cd/m² calibrated luminance. Minimum luminance at Lmax=1000cd/m² is not explicitly re-stated, but the calibrated luminance is 500 cd/m².
Luminance Max recommend: Lmax(r)=500cd/m², Lmin(r)=0.8cd/m²	Calibrated luminance is 500 cd/m².
Intrinsic bit-depth of the panel: 10 bit per each pixel	10.0 bit grayscale (1024 steps) achieved by 16bit LUT (Look-up Table)
Intrinsic luminance response: dJND per dP<3.000, dJNDs/dP max error<2.000, JNDs/P RMS error<1.000 (based on AAPM-TG18 Advanced Luminance Response, 4.3.5)	"Refer to actual luminance response data." (Specific numerical performance not provided in summary)
Angular dependency of luminance: LR'≥175, Κδ>30%	"Refer to actual Luminance uniformity data." (Specific numerical performance not provided in summary)
Luminance uniformity: Less than 30% based on AAPM-TG18 4.4	"Refer to actual Luminance uniformity data." (Specific numerical performance not provided in summary)
Geometrical distortion: Less than 2.0% based on AAPM-TG18	"Refer to actual Geometrical Distortion data." (Specific numerical performance not provided in summary)
Bi-directional reflection distribution function: Refer to Max allowable ambient luminance in Tables 4 and 5 on AAPM-TG18 4.2.4.	"Refer to actual Reflectance Data." (Specific numerical performance not provided in summary)
Pixel fill factor: 30% Min.	"Refer to Data of Pixel fill factor." (Specific numerical performance not provided in summary)
Noise power spectrum (weiner spectrum)	"Refer to actual data." (Specific numerical performance not provided in summary)
Veiling glare: Glare Ratio (GR) ≥ 400 GR=(Lb-Ln)/(L-Ln) based on AAPM-TG18 4.7.4	"Refer to actual veiling glare ratio data." (Specific numerical performance not provided in summary)
Chromaticity: Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4	"Refer to Chromaticity actual data." (Specific numerical performance not provided in summary)
Artifacts: pixel dropouts including spatial distribution: Class (pixel) II. Refer to table 3 on 3.4.13 ISO13406-2.	"Refer to table 3 on 3.4.13 ISO13406-2." (Specific performance details not provided in summary)
Artifacts: phase/clock issues flicker, ringing, ghosting, image sticking	"By visible check, no ringing, ghosting image sticking." (Flicker, phase/clock issues not explicitly addressed as "no.")
Spatial resolution, spatial MTF	"Refer to actual MTF data." (Specific numerical performance not provided in summary)
Temporal response: Rise Time Tr, Fall Time Tf, Tr, Tf<55mS.	"Refer to actual data." (Specific numerical performance not provided in summary)
Stability: Ko within +/- 10% deviation to DICOM GSDF, based on AAPM-TG18 Luminance Response 4.3.4 via temperature stress 0 degC, 20 degC, 25 degC, 30 deqC, 40 deqC	"Refer to actual measured data." (Specific numerical performance not provided in summary, but indicates testing was done across given temperatures.)
Calibrated Luminance	500cd/m²
Contrast Ratio	Min.1000 : 1, Typ. 1300 : 1
Grayscale	10.0 bit (1024 gradation)

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

Sample Size: Not Applicable. This device is a display monitor, not an AI or diagnostic algorithm, so there is no "test set" in the context of medical images or patient data. Its performance is evaluated through physical and optical measurements according to display standards.
Data Provenance: Not Applicable. The testing involves measurements of the monitor's physical characteristics, not medical image data.

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

Not Applicable. Ground truth in this context refers to standardized measurements and specifications of the display, not clinical interpretations. Compliance is based on established display performance standards like AAPM-TG18.

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

Not Applicable. This is not a clinical study involving diagnostic interpretations.

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

No. This is a technical submission for a display monitor, not an AI or diagnostic imaging device.

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

Not Applicable. This product is a display monitor, not an algorithm. Its performance is inherently "standalone" in that it is measured as a device, without a "human-in-the-loop" component in its evaluation for this submission (though it is intended for human-in-the-loop diagnostic use). The study described is a technical performance test of the monitor itself.

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

The ground truth for the device's technical acceptance criteria is based on established industry standards and specifications for medical displays (e.g., AAPM-TG18, ISO13406-2) and the manufacturer's own specifications. These are objective, measurable physical parameters.

8. The sample size for the training set

Not Applicable. This is a display monitor, not a machine learning model.

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

Not Applicable. This is a display monitor, not a machine learning model.

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 stylized caduceus symbol, which features three abstract human profiles in a row, with a triple-strand helix wrapping around them. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 8, 2015

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

Re: K151007

Trade/Device Name: 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2 (CL21550) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 14, 2015 Received: April 15, 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)

K151007

Device Name CCL550i2 (CL21550)

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 14, 2015
Device Name:	21.3 inch (54 cm) inch Color Digital Mammography LCD MonitorCCL550i2 (CL21550)
Common Name:	CCL550i2, CL21550
Classification Name:	Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System)
Predicate Device:	21.3 inch (54 cm) inch Monochrome Digital Mammography LCDMonitor MS55i2 (ML21055) (K131137)
Device Description:	CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCDmonitor whose display resolution is 2048 x 2560 (landscape), 2560 x2048 (portrait) supporting DVI (digital visual interface) andDisplayPort.
Intended Use:	21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCDMonitor CCL550i2 (CL21550) is intended to be used in displayingand viewing medical images for diagnosis by trained medicalpractitioners. It is to be used in digital mammography PACS andmodalities including FFDM.
Substantial Equivalence:	CCL550i2 (CL21550) shares the same characteristics with ourpredicate device MS55i2 (ML21055) (K131137) except for the LCDpanel and standard software.

JVC KENWOOD Corporation

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

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Display System Description
1. Active-Matrix Liquid-Crystal Displays (AMLCD) panel manufacturer, technology, Screen sizeand pixel pitch:
Screen size: 422.4(H)mm x 337.92(V) mm at landscape display, 337.92(H)mm x 422.4(V)mmat portrait display, Pixel pitch: 0.165mm(H) x 0.165mm(V) at landscape display, 0.165mm(H)x 0.165(V) at portrait display
• Communicating ports:
Serial communication: USB (upstream x1, downstream x2)
2. Graphics card and software
• Digital-to-Analog converters: speed and precision:
Only Digital operation, Digital to Analog converters are not provided.
• Software included: calibration
JVCKENWOOD's calibration software called "FCAL" optimizes the display's performance
using DICOM GSDF gamma and luminance. Calibration is recommended quarterly.
• On-screen GUI: On-screen GUI is not provided.
• Panel user controls: power switch
Technical Specification
1. Measuring EquipmentRefer to List.
2. Declared and actual (measured with test pattern in the screen) array size:Declared array size (spec): 422.4(H)mm x 337.92(V) mmActual array size (measured): 422.7(H)mm x 338.0(V)mm
3. Luminance response
• max and min achievable luminance:[SPEC] Luminance Max (Lmax)=1000cd/m²,Luminance Min (typ) = 0.77cd/m² at Lmax=1000cd/m²
• max and min recommended (operational) luminance:[SPEC] Luminance Max recommend: Lmax(r)=500cd/m², Lmin(r)=0.8cd/m²
• intrinsic bit-depth of the panel:[SPEC] 10 bit per each pixel
• true output bit-depth by performing visual test with gradient test pattern:[SPEC] 10.0bit grayscale (1024 steps) achieved by 16bit LUT (Look-up Table) inthe Display hardware.
• intrinsic luminance response at 256 digital values:[SPEC] dJND per dP<3.000, dJNDs/dP max error<2.000,JNDs/P RMS error<1.000Above spec is based on AAPM-TG18 Advanced Luminance Response, 4.3.5Refer to actual luminance response data.
4. Angular Dependency
• angular dependency of luminance:[SPEC] LR'≥175, Κδ>30%
5. Luminance uniformity[SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminanceuniformity data.
6. Geometrical distortion[SPEC] Less than 2.0% based on AAPM-TG18. Refer to actual GeometricalDistortion data.

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1. Display reflectance
- Bi-directional reflection distribution function [SPEC] Refer to Max allowable ambient luminance in Tables 4 and 5 on AAPM-TG18 4.2.4.

Refer to actual Reflectance Data.

1. Noise
- · Pixel fill factor [SPEC] 30% Min. Refer to Data of Pixel fill factor.
- · Noise power spectrum (weiner spectrum) [SPEC] Refer to actual data.

9. Veiling glare

[SPEC] Glare Ratio (GR) ≥ 400 GR=(Lb-Ln)/(L-Ln) based on AAPM-TG18 4.7.4 Refer to actual veiling glare ratio 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.

11. Artifacts

pixel dropouts including spatial distribution [SPEC] Class (pixel) II. Refer to table 3 on 3.4.13 ISO13406-2.
phase/clock issues flicker
· miscellaneous including ringing, ghosting, image sticking [SPEC] By visible check, no ringing, ghosting image sticking
1. Spatial resolution, spatial MTF [DATA] Refer to actual MTF data.

13. Temporal response

rise and fall time constants for 5-95% and 40-60% transitions [SPEC] Rise Time Tr, Fall Time Tf, Tr, Tf<55mS. Refer to actual data.
1. Stability (possibly determined via temperature or time stress tests)
- · of luminance response, of temporal response, of described artifacts [SPEC] Ko within +/- 10% deviation to DICOM GSDF, based on AAPM-TG18 Luminance Response 4.3.4 via temperature stress 0 degC, 20 degC, 25 degC, 30 deqC, 40 deqC Refer to actual measured data.

[fefxos = for example, following ... or similar]

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		5M Color Digital Mammograpl
		CD Monitor CCL550i2 (CL2155
0(k) Numb
isplay Are put Signa		lorizontal: 337.92mm, Vertical: 422.41
		DisplayPort
aximum Displa		048 x 2560 dots
canning Frequer		LandscapPortraitizontal:129.1KHz Vertical:50Hz izontal:103.5KHz Vertical:50Hz
aximum Image Cloc		85 MHz
aximum Luminancı alibrated Luminanc วntrast Ratio		Min.700cd/m² Typ. 1000cd/m² (as LCD component) (500cd/m² calibrated lluminance)

		Min.1000 : 1 Typ. 1300 : 1
	Min.900 : 1 Typ.1200 : 1 CR>50 Typ.176 horizontal/vertical Software (Standard): Medivisor Software (Standard): Medivisor Calibration Sensor (Optional): Chroma5 (X-Rit	R>50 Typ.176 horizontal/vertic:
ewing Angle uminance Calibratio		tware (Standard): FCAL
Optional)		ibration Sensor (Optional): Chroma5 (X-Rite
erial Communicati		B: Downstream port x 2, Upstream port
ayscale	Uest Downstream Boot in 2. Uperream Port x 1 10.3 bit it CoSA C22.2 No. 601-1. FOOD, V. FOOD, V. FOOD, V. FOOD, V. FOOD, V. POOD, V. POOD, V. POOD, V. POOLES NGC 3. BOOKWAY N	0.0 bit (1024 gradation
afety Standa		60601-1,NSI/AAMI ES60601-1, CAN/CSA-C22.2 No.
		B, VCCI-B, MDD/CE
eight & Dimensi		Net




ower Suppl	AC100-240V, 1.5-0.6A, 50/60Hz	C100-240V, 1.5-0.6A, 50/60Hz

bstantial Equivalence Compariso

Similarities

Similarities:
CCL55012 (CL21550) employs the same driver board, tilt stand, power supply, etc. except of those of LCD Panel and standard software

Differences:
CCL550i2 (CL21550) employs different LCD panel and standard softwar

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CCL550i2 (CL21550) can be considered to have equivalent display performances to those of the predicate device MS55i2 (ML21055) due to the following reasons:

a. The maximum display sizes (2048*2560) and the active area sizes (337.92mm (H) x 422.4mm (V)) used for the both devices are the same.
b. The DICOM calibrated luminance value of the both devices are the same (500 cd/m²) though the typical maximum luminance value (typ. 1000cd/m²) is lower than that of the predicate device (typ. 1200cd/m²). And Panels of the both devices are used LED backlight. The high luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights. 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.
c. 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.
d. Both devices support Digital Visual Interface (DVI) and DisplayPort.
e. As for the maintenance, the same QC software is used for both devices have Front Sensor to stabilize the luminance.
f. 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 8 "Validation & Verification: Integration Test Report" and section 9 "Validation & Verification: System Test Report" in "Application".
g. The overall design of the CCL550i2 (CL21550) 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 CCL550i2 (CL21550) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

Conclusion

The 5M pixel Color LCD Monitor, CCL550i2 (CL21550) is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of the primary components employed by the proposed device are the same to those of the predicate device except for the LCD panel, and the 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).