(18 days)
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor. Their displays' resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
Here's a breakdown of the acceptance criteria and study information for the JVC Kenwood medical monitors, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the JVC KENWOOD monitors (MS55i2 and CCL550i2) primarily focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce GX540) rather than presenting specific, quantitative acceptance criteria and results. The "acceptance criteria" can be inferred as matching or being equivalent to the key performance specifications of the predicate device, especially those related to image quality and functionality for diagnostic medical imaging.
| Feature / Acceptance Criteria (Inferred from Predicate Equivalence) | Predicate Device (EIZO RadiForce GX540) Specification | JVC KENWOOD MS55i2 (ML21055, MD211G5) Performance | JVC KENWOOD CCL550i2 (CL21550) Performance |
|---|---|---|---|
| Response Time (typical) | 25ms (On/Off) | 25ms (On/Off) | 25ms (On/Off) |
| Resolution or Matrix Size | 5MP (2048 x 2560) | 5MP (2048 x 2560) | 5MP (2048 x 2560) |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | TFT Color LCD Panel (IPS) |
| Backlighting | LED | LED | LED |
| Maximum Luminance | Min. 850cd/m², Typ. 1200cd/m² | Min. 850cd/m², Typ. 1200cd/m² | Min. 700cd/m², Typ. 1000cd/m² |
| DICOM Calibrated Luminance | 500cd/m² | 500cd/m² | 500cd/m² |
| Viewing Angle (CR>50) | Horizontal: Typ. 176°, Vertical: Typ. 176° | Horizontal: Typ. 176°, Vertical: Typ. 176° | Horizontal: Typ. 176°, Vertical: Typ. 176° |
| Display Area | Horizontal: 337.92mm, Vertical: 422.4mm | Horizontal: 337.92mm, Vertical: 422.4mm | Horizontal: 337.92mm, Vertical: 422.4mm |
| Aspect Ratio | 4:5 | 4:5 | 4:5 |
| Pixel Pitch | Horizontal: 0.165mm, Vertical: 0.165mm | Horizontal: 0.165mm, Vertical: 0.165mm | Horizontal: 0.165mm, Vertical: 0.165mm |
| Contrast Ratio | Min. 900:1, Typ. 1200:1 | Min. 900:1, Typ. 1200:1 | Min. 1000:1, Typ. 1300:1 |
| Grayscale Tones (10-bit DisplayPort) | 1,024 from a palette of 16,369 tones | 1,024 from a palette of 12,277 tones | 1,024 from a palette of 65,473 tones |
| Grayscale Tones (8-bit) | 256 from a palette of 16,369 tones | 256 from a palette of 12,277 tones | 256 from a palette of 65,473 tones |
| Non-Uniformity Compensation | Digital Uniformity Equalizer (DUE) | Digital Uniformity correction System | Digital Uniformity correction System |
| Input Video Signal | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 | DVI-D x1, DisplayPort x1 |
| QA Software | RadiCS | QA Medivisor / Medivisor NX, F-CAL | QA Medivisor / Medivisor NX, F-CAL |
| Built-in Front Sensor | Integrated Front Sensor (IFS) | Built-in Front Sensor | Built-in Front Sensor |
| Ambient Light Sensor | Ambient Light Sensor (ALS) | Built-in ambient Light Sensor | Built-in ambient Light Sensor |
Explanation of Differences and Performance Justification:
- Grayscale Tones: While the palette size for grayscale tones differs, the document states, "But our monitors pass the exams in AAPM-TG18 4.3 'Luminance Response'. Our monitors are equivalent to the predicated device." This indicates that despite the numerical difference in palette size, the devices meet the relevant image quality standards for grayscale reproduction.
- Non-Uniformity Compensation: The JVC KENWOOD system is considered "equivalent to the predicated device's one" in making visual performance "much better in the point of luminance (monochrome and color version) and chromaticity."
- Maximum Luminance (CCL550i2): The color monitor has a lower maximum luminance, but the document clarifies, "However DICOM Calibrated luminance is same as the predicated device. Then actual performance for diagnosis is the same." This is a crucial point, as the calibrated luminance is what's critical for diagnostic viewing.
- Contrast Ratio (CCL550i2): The color model's contrast ratio is higher, which is generally a positive difference.
2. Sample Size Used for the Test Set and Data Provenance
This document does not contain information about a "test set" in the context of clinical images or patient data. The evaluation is focused on the technical performance specifications of the monitors themselves. Therefore, sample sizes for test sets in this sense are not applicable.
- Data Provenance: The data presented is from the manufacturer's (JVC KENWOOD Corporation) testing and comparison against the specifications of the predicate device. The company is based in Japan. This is more akin to bench testing of hardware specifications rather than a clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a technical comparison of monitor specifications, not an evaluation of diagnostic accuracy based on expert interpretation of images. The "ground truth" here is the adherence to technical standards and performance specifications, likely established through engineering measurements and adherence to industry standards like AAPM-TG18.
4. Adjudication Method for the Test Set
Not applicable, as no human reader studies or clinical test sets requiring adjudication are described.
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 510(k) summary is for medical display monitors and does not involve AI or reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This 510(k) summary is for medical display monitors and does not involve algorithms or AI performance.
7. The Type of Ground Truth Used
The "ground truth" used in this submission is primarily technical specifications and performance measurements against established industry standards (e.g., DICOM, AAPM-TG18) and direct comparison with a legally marketed predicate device. The goal is to demonstrate that the new devices perform equivalently or better in terms of visual characteristics critical for medical image diagnosis.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm being developed or trained described in this document.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned in this document.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2016
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro Engineering Specialist 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 JAPAN
Re: K160326
Trade/Device Name: 5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) 5MP Color LCD Monitor CCL550i2 (CL21550) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 29, 2016 Received: February 5, 2016
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
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Ocks
Robert Ochs, Ph.D. 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)
K160326
Device Name
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) 5MP Color LCD Monitor CCL550i2 (CL21550)
Indications for Use (Describe)
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and
5MP Color LCD Monitor CCL550i2 (CL21550)
are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
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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Image /page/3/Picture/0 description: The image shows the logo for JVC KENWOOD. The logo is in a dark blue color. Below the logo is the text "creates excitement & peace of mind" in a light blue color.
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: | January 29, 2016 | ||
| Device Name: | 1. 5MP Monochrome LCD Monitor MS55i2(ML21055, MD211G5)2. 5MP Color LCD Monitor CCL550i2(CL21550) | ||
| Common Name: | 1. MS55i2 (ML21055, MD211G5)2. CCL550i2 (CL21550) | ||
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | ||
| Predicate Device: | 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) | ||
| Device Description: | MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochromeLCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) colorLCD monitor. Their displays' resolution is 2048 x 2560 (landscape),2560 x 2048 (portrait) supporting DVI (digital visual interface) andDisplayPort. | ||
| Intended Use: | 5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and5MP Color LCD Monitor CCL550i2 (CL21550)are intended to be used in displaying and viewing medical imagesfor diagnosis by trained medical practitioners.They are to be used in digital mammography PACS, modalitiesincluding FFDM, and breast tomosynthensis |
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Image /page/4/Picture/0 description: The image shows the JVC KENWOOD logo in dark blue. Below the logo is the text "creates excitement & peace of mind" in a lighter blue color. The logo is simple and modern, with a focus on the company's name and tagline.
510(k) SUMMARY
Substantial Equivalence:
LCD Monitor MS55i2(ML21055, MD211G5)
| EIZO RadiForce GX540 | LCD Monitor MS55i2(ML21055, MD211G5) | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | K151883 | K131137 | JVC KENWOOD usestypical data provided by thepanelmanufacturer.For further explanationrefer to temporal responseof MS55i2. |
| Response Time(typical) | 25ms (On/Off) | 25ms (On/Off) | |
| Resolution orMatrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| ScreenTechnology | TFT MonochromeLCD Panel (IPS) | TFT MonochromeLCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| MaximumLuminance | Min.850cd/m²Typ.1200cd/m². | Min.850cd/m²Typ.1200cd/m². | - |
| DICOMCalibratedLuminance | 500cd/m² | 500cd/m² | - |
| Viewing Angle | CR>50Horizontal: Typ.176Vertical: Typ.176 | CR>50Horizontal: Typ.176Vertical: Typ.176 | - |
| Display Area | Horizontal: 337.92mmVertical: 422.4mm | Horizontal: 337.92mmVertical: 422.4mm | - |
| Aspect Ratio | 4:5 | 4:5 | - |
| Pixel Pitch | Horizontal: 0.165mmVertical: 0.165mm | Horizontal: 0.165mmVertical: 0.165mm | - |
| Contrast Ratio | Min.900 : 1Typ.1200 : 1 | Min.900 : 1Typ.1200 : 1 | - |
| GrayscaleTones | 10-bit (DisplayPort): 1,024from a palette of 16,369tones8-bit: 256 from a palette of16,369 tones | 10-bit (DisplayPort): 1,024from a palette of 12,277 tones8-bit: 256 from a palette of12,277 tones | Maximum bit depth byDisplay port is 10 bit, it byDVI is 8 bit.Tone between the predicateddevice and our monitors aredifferent. But our monitorspass the exams inAAPM-TG18 4.3"Luminance Response".Our monitors are equivalentto the predicated device |
| Non-UniformityCompensation | Digital UniformityEqualizer (DUE) | Digital Uniformity correctionSystem | Our Uniformitycorrection system isequivalent to thepredicated device's one.This system is helpful tomake visual performancemuch better in the pointof luminance(monochrome and colorversion) and chromaticity. |
| Input Video Signal | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 | - |
| ScanningFrequency | 31 - 135 kHz / 24 - 61 HzFrame synchronousmode: 24.5 - 25.5 Hz, 49- 51 Hz | Portrait:Horizontal:129.1KHzVertical:50HzLandscape:Horizontal:103.5KHz | JVC KENWOOD specifiesonly maximum scanningfrequency which is based onthe LCD panel drivingspecification. |
| Vertical:50Hz | |||
| Dot Clock | 290MHz | 285 MHz | JVC KENWOOD specifiesthe dot clock which is basedon the LCD panel drivingspecification. |
| PowerRequirements | AC 100 - 120 V,200 - 240 V: 50 / 60 Hz | AC100-240V, 50/60Hz | JVC KENWOODspecification covers powerrequirement specification ofthe predicated device. |
| Power | 108 W | 80W | - |
| Consumption | Less than 0.7 W | Less than 2W | - |
| Power | DVI DMPM, | DVI DMPM, | - |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | - |
| QA Software | RadiCS | QA Medivisor / Medivisor NXF-CAL | - |
| Sensor | Integrated Front Sensor(IFS) | Built- in Front Sensor | - |
| Backlight Sensor (BS) | None | Brightness stability iscontrolled by the built-inFront sensor. | |
| Ambient Light Sensor(ALS) | Built-in ambient Light Sensor | - | |
| Presence Sensor (PS) | None | - | |
| USB Ports /Standard | 1 upstream,2 downstream / Rev. 2.0 | 1 upstream,2 downstream / Rev. 2.0 | - |
| Dimensionsw/o Stand(W x H x D) | 388 x 496 x 99 mm | (AR, N) 474.5 x 390 x 98.1 mm(F) 474.5 x 390 x 103.7 mm | - |
| EIZO RadiForce GX540 | LCD Monitor CCL550i2(CL21550) | Explanation of Differences | |
| 510(k) Number | K151883 | K151007 | - |
| Response Time(typical) | 25ms (On/Off) | 25ms (On/Off) | JVC KENWOOD uses typical data provided by the panel manufacturer.For further explanation refer to temporal response of CCL550i2 |
| Resolution orMatrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| ScreenTechnology | TFT Monochrome LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| MaximumLuminance | Min.850cd/m2Typ.1200cd/m2. | Min.700cd/m2Typ. 1000cd/m2 | Maximum luminance of color model is lower than monochrome panel.However DICOM Calibrated luminance is same as the predicated device. |
| DICOMCalibratedLuminance | 500cd/m2 | 500cd/m2 | Then actual performance for diagnosis is the same. |
| Viewing Angle | CR>50Horizontal: Typ.176Vertical: Typ.176 | CR>50Horizontal: Typ.176Vertical: Typ.176 | - |
| Display Area | Horizontal: 337.92mmVertical: 422.4mm | Horizontal: 337.92mmVertical: 422.4mm | - |
| Aspect Ratio | 4:5 | 4:5 | - |
| Pixel Pitch | Horizontal: 0.165mmVertical: 0.165mm | Horizontal: 0.165mmVertical: 0.165mm | - |
| Contrast Ratio | Min.900 : 1Typ.1200 : 1 | Min.1000 : 1Typ. 1300 : 1 | Contrast ratio of the color model is higher than the monochrome model. |
| GrayscaleTones | 10-bit (DisplayPort): 1,024 from a palette of 16,369 tones8-bit: 256 from a palette of 16,369 tones | 10-bit (DisplayPort): 1,024 from a palette of 65,473 tones8-bit: 256 from a palette of 65,473 tones | Maximum bit depth by Display port is 10 bit, it by DVI is 8 bit.Tone between the predicated device and our monitors are different. But our monitors pass the exams in AAPM-TG18 4.3 "Luminance Response".Our monitors are equivalent to the predicated device |
| Non-UniformityCompensation | Digital Uniformity Equalizer (DUE) | Digital Uniformity correction System | Our Uniformity correction system is equivalent to the predicated device's one.This system is helpful to make visual performance much better in the point of luminance (monochrome and color version) and chromaticity. |
| Input Video Signal | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 | - |
| ScanningFrequency | 31 - 135 kHz / 24 - 61 HzFrame synchronous mode: 24.5 - 25.5 Hz, 49 - 51 Hz | Portrait:Horizontal: 129.1 KHzVertical: 50HzLandscape:Horizontal: 103.5 KHzVertical: 50Hz | JVC KENWOOD specifies only maximum scanning frequency which is based on the LCD panel driving specification. |
| Dot Clock | 290MHz | 285 MHz | JVC KENWOOD specifies the dot clock which is based on the LCD panel driving specification. |
| PowerRequirements | AC 100 - 120 V,200 - 240 V: 50 / 60 Hz | AC100-240V, 50/60Hz | JVC KENWOODspecification covers powerrequirement specification ofthe predicated device. |
| Power | 108 W | 95W | - |
| Consumption | Less than 0.7 W | Less than 2W | - |
| Power | DVI DMPM, | DVI DMPM, | - |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | - |
| QA Software | RadiCS | QA Medivisor / Medivisor NXF-CAL | - |
| Sensor | Integrated Front Sensor(IFS) | Built- in Front Sensor | - |
| Backlight Sensor (BS) | None | Brightness stability iscontrolled by the built-inFront sensor. | |
| Ambient Light Sensor(ALS) | Built-in ambient Light Sensor | - | |
| Presence Sensor (PS) | None | - | |
| USB Ports / | 1 upstream, | 1 upstream, | - |
| Standard | 2 downstream / Rev. 2.0 | 2 downstream / Rev. 2.0 | - |
| Dimensionsw/o Stand(W x H x D) | 388 x 496 x 99 mm | (AR, N) 474.5 x 390 x 98.1 mm(F) 474.5 x 390 x 103.7 mm | - |
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MS55i2 adopts exactly the same panel as the predicated device, therefore its specification is completely same as the predicated device
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Maximum luminance of the CCL550i2-panel is low, but calibrated luminance at the time of factory shipment state is 500cd/m2.
This value is same as the predicated one. Moreover, contrast ratio of CCL550i2-panel is better, and other specifications in comparison items are similar. Therefore, our monitor is equivalent to the predicated device.
JVC KENWOOD Corporation Professional & Healthcare Division
3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan
§ 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).