(16 days)
20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) 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.
ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome 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).
The provided document describes the 510(k) premarket notification for the JVC KENWOOD CORPORATION's 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205). The document primarily focuses on establishing substantial equivalence to a predicate device (ME201L, K021738) rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.
However, based on the Technical Specification and Substantial Equivalence Comparison sections, we can infer some performance criteria and how the device (ME205) is claimed to meet them, primarily by comparison to its predecessor and adherence to display standards.
Here's an analysis based on the provided text, specifically addressing the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Technical Specification") | Reported Device Performance (ME205 (ML20205)) | Basis for Performance Claim |
|---|---|---|
| Luminance Uniformity | Less than 30% based on AAPM-TG18 4.4 | "Refer to actual Luminance uniformity data" (data not provided in this document) |
| Pixel Defects / Fault | Class II or more (in context of ISO13406-2) | ISO13406-2 (standard adherence) |
| Artifacts (flicker, ringing, ghosting, image sticking) | No flicker, ringing, ghosting, and image sticking by visible check | "By visible check" |
| Chromaticity Measurement (at 5%, 50%, 95% Level) | "Refer to actual data" (data not provided) | - |
| Chromaticity (Delta (u', v') at 80% Lmax) | ≤ 0.01 based on AAPM-TG18 4.8.4 | "Refer to Chromaticity actual data" (data not provided) |
| Power On Luminance Drift | "Refer to actual data" (data not provided) | - |
| Maximum Luminance | 410 cd/m² DICOM calibrated; 1000 cd/m² typ. As LCD component | Specification (higher than predicate's 700 cd/m² for LCD component) |
| Luminance Calibration | Software-based calibration, Photo Sensor (optional): X-Rite Chroma 5 | Feature description |
| Contrast Ratio | Typ. 1000:1 | Specification |
| DICOM GSDF Compliance | Displays images in accordance with DICOM GSDF by default | "factory calibrated display mode stored in lookup tables" |
| Backlight Stability | Stabilizes luminance | Backlight Sensor feature, LED backlight (longer lasting, stable) |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 (Class B) | Third-party certifiers and JVC KENWOOD Corporation testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a clinical "test set" sample size or data provenance in the context of a study for diagnostic accuracy. The testing mentioned appears to be related to technical performance characteristics of the monitor itself (e.g., luminance, chromaticity, artifacts) rather than a diagnostic performance study involving medical images and human readers. The "Technical Data" mentioned for comparison with the predicate device is not provided, and its methodology (e.g., sample size of images or tests) is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The document describes a medical monitor, not an AI or diagnostic device that would require expert-established ground truth for a test set. The "visible check" for artifacts would likely involve internal quality control personnel rather than external medical experts validating ground truth in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. No diagnostic "test set" and thus no adjudication method for ground truth is 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
This information is not applicable/not provided. The device is a medical monitor, 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/not provided. The ME205 (ML20205) is an LCD monitor for displaying medical images, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. The document details the technical specifications and substantial equivalence of a display monitor. Ground truth, in the context of clinical diagnostic accuracy, is not relevant to this type of device submission. The "ground truth" here would be the physical measurements of the monitor's performance characteristics against industry standards (e.g., AAPM-TG18, ISO13406-2) and its own specifications.
8. The sample size for the training set
This information is not applicable/not provided. The device is a monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, there is no training set for this device.
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2014
JVC KENWOOD CORPORATION % Mr. Tsukasa Tashiro Senior Manager 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa, 221-0022 JAPAN
Re: K143076
Trade/Device Name: 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 24, 2014 Received: October 27, 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, 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
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) Not known K143076 Device Name ME205 (ML20205)
Indications for Use (Describe)
20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) 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.
Type of Use (Select one or both, as applicable)
区 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 (1/14)
PSC Publishing Services (301) 443-6740 EF
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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, Senior ManagerEmail: tashiro.tsukasa@jvckenwood.comTel: +81.258.24.6611Fax: +81.258.24.6617 |
| Date Prepared: | October 24, 2014 |
| Device Name: | 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205) |
| Common Name: | ME205, ML20205 |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 20.1 inch (51 cm) Monochrome LCD Monitor ME201 (MDL2006A)(K021738) |
| Device Description: | ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome LCDmonitor whose display resolution is 1600 x 1200 (landscape),1200 x 1600 (portrait) supporting DVI-I (both digital and analoginterface) and DisplayPort (digital interface). |
| Intended Use: | 20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor, ME205(ML20205) is intended to be used in displaying and viewingmedical images for diagnosis by trained medical practitioners. It isnot meant to be used in digital mammography. |
| Substantial Equivalence: | ME205 (ML20205) shares the same technical characteristics,application and intended use with our predicate device ME201(K021738). |
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Technical Specification
-
- Luminance uniformity [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data
-
- Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2
-
- Artifacts
- phase/clock issues flicker
- · miscellaneous including ringing, ghosting, image sticking
- [SPEC] By visible check, no flicker, ringing, ghosting and image sticking
-
- Chromaticity Measurement of 5%, 50%, 95% Level [SPEC] Refer to actual data.
-
- Chromaticity [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 Refer to Chromaticity actual data
-
- Power On Luminance Drift [SPEC] Refer to actual data.
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| ME201L (MDL2006A) | ME205 (ML20205) | |
|---|---|---|
| 10(k) Number | K021738 | Not Known |
| Display Area | Horizontal: 408.0mm, Vertical: 306.0mm | Horizontal: 408.0mm, Vertical: 306.0mm |
| Pixel Pitch | 0.255 mm x 0.255mm | 0.255 mm x 0.255mm |
| Input Signal | Video signal-analog 0.7Vpp/75 ΩDVI-D digital video signal | DVI-I 29-pin connector, DisplayPort connector |
| Maximum Resolution | 1600 x 1200 at landscape display | 1200 x 1600 at portrait display1600 x 1200 at landscape display |
| Scanning Frequency | Horizontal: 31 – 80kHzVertical: 55 – 85Hz | Horizontal: 30 – 75kHzVertical: 55 – 60Hz |
| Maximum Image Clock | 162MHz | 162MHz |
| Maximum Luminance | 410 cd/m² DICOM calibrated700 cd/m² typ. As LCD component | 410 cd/m² DICOM calibrated1000 cd/m² typ. As LCD component |
| Luminance Calibration(Optional) | Software | Software |
| Photo Sensor (optional): DTP92(X-Rite) | Photo Sensor (optional): X-Rite Chroma 5 | |
| Contrast Ratio | Typ. 1000:1 | Typ. 1000:1 |
| Serial Communication | RS-232C | USB |
| Safety Standards | Medical Safety: UL2601-1, CSA No. 601-1EN60601-1 | 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: 10.8kg453(w) x 466(H) x 251(D) mm (landscape)353(w) x 520(H) x 251(D) mm (portrait)Packed: 14kg470(W) x 680(H) x 340(D) mm | Net: 9.6kg453(w) x 462 – 523(H) x 220(D) mm (landscape)353(w) x 512 – 573(H) x 220(D) mm (portrait)Packed: 12.5kg470(w) x 675(H) x 347(D) mm |
| Power Supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
bstantial Equivalence Compari
E205 (ML20205) employs a different LCD panel, power supply, and main board from the predicate devi
lE201L (K021738). Differences:
- E205 (ML20205) employs the same front bezel and tilt stand as those employed on the predicate device ME20
K021738). The back enclosures of both devices are similar to each ot similarities:
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ME205 (ML20205) can be considered to have equivalent display performances to those of the predicate device ME201L (K021738) due to the following reasons:
- a. The active sizes (408.0mm x 306.0mm) and the maximum display resolution (1600 x 1200) used for the both devices are the same.
- b. The DICOM calibrated luminance values of the both devices are the same (410cd/m2). In regard to the maximum luminance, the value of the predicate device ME201L (K021738) is 700cd/m2, whereas that of ME205 (ML20205) is set to a higher value of 700cd/m2. Additionally ME205 (ML20205) realizes high luminance at constantly stable level by adopting LED backlight, which lasts longer than conventional CCFL backlights do.
- The LED backlight was newly employed instead of CCFL backlight because it is ﻥ 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.
- The both devices display images in accordance with DICOM GSDF by default utilizing d. the factory calibrated display mode stored in lookup tables inside of them.
- The predicate device ME201L (K021738) supports DVI-D (digital interface) and D-Sub e. (analog interface), whereas ME205 (ML20205) 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 ME205 (ML20205) 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 ME205 (ML20205) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 2M pixel Monochrome LCD Monitor, ME205 (ML20205) 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.
§ 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).