(35 days)
21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS25i2 (ML21025) 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.
MS25I2 (ML21025) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.
The provided document is a 510(k) summary for the TOTOKU 21.3 inch (54 cm) Monochrome LCD Monitor MS25I2 (ML21025). This document describes the device and its substantial equivalence to a predicate device, rather than a study proving the device's performance against specific clinical acceptance criteria in the context of an AI/algorithm-based diagnostic product.
Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, how ground truth for training set was established) are not applicable to this document as it pertains to a display monitor, not a diagnostic algorithm.
However, I can extract information related to the technical specifications and verification performed for the display monitor itself.
Acceptance Criteria and Device Performance (Technical Specifications)
The document lists technical specifications (which can be considered acceptance criteria for a display monitor) and implies that the device meets them, primarily through comparison to the predicate device and internal testing.
| Acceptance Criteria (Technical Specification) | Reported Device Performance / Compliance |
|---|---|
| 1. Luminance uniformity | Less than 30% based on AAPM-TG18 4.4. (Refer to actual Luminance uniformity data - data not provided in this extract) |
| 2. Pixel Defects / Fault | Class II or more. ISO13406-2. |
| 3. Artifacts (phase/clock issues, flicker, ringing, ghosting, image sticking) | By visible check, no flicker, ringing, ghosting and image sticking. |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level | Data not provided in this extract |
| 5. Chromaticity (Delta (u', v')) | Delta (u', v') $(u', v') ≤ 0.01$ measured at 80% Lmax based on AAPM-TG18 4.8.4. (Refer to Chromaticity actual data - data not provided in this extract) |
| Maximum Luminance | 1900 cd/m² (higher than predicate 1800 cd/m²) |
| Contrast Ratio | 1400:1 (higher than predicate 700:1) |
| Grayscale | 10.3 bit (1276 gradation) |
| Safety Standard compliance | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B) |
| DICOM calibrated luminance values | 410 cd/m² (same as predicate) |
| Display images in accordance with DICOM GSDF | Yes, by default utilizing factory calibrated display mode. |
| Support Digital Visual Interface (DVI) and DisplayPort | Yes. |
| Front Sensor for luminance stabilization | Yes, enables automatic grayscale calibration. Accuracy data included in "Verification & Validation" section (not provided in extract). |
| Ambient Light Sensor | Yes. |
Study Information (Device Verification and Validation Summary)
The document states:
- "The overall design of the MS25i2 (ML21025) 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 MS25i2 (ML21025) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance."
- Regarding the Front Sensor, "The accuracy data of the calibration with external sensors and that with Front Sensor is included in section 9 'Verification & Validation' in 'Application'."
However, the specific "Verification & Validation" section with detailed study methodologies, sample sizes, and detailed data is not provided in the supplied text. The evidence for meeting the acceptance criteria is generally stated as:
- Comparison to predicate device: The new device (MS25I2) is considered substantially equivalent to the predicate device (MS23I2) because it shares identical characteristics in display size, active area, input signals, maximum display resolution, pixel pitch, scanning frequency, maximum image clock, luminance calibration software/sensor, serial communication, and grayscale. Key differences like maximum luminance and contrast ratio are improved, and the LED backlight (a new feature) is deemed to have no adverse effects on image quality.
- Compliance with international standards: Safety and EMC standards validation by third-party certifiers.
- Internal system and performance tests: JVC KENWOOD Corporation conducted these tests, with the conclusion that "None of the tests revealed behaviors inconsistent with the expected performance."
Not Applicable (N/A) for AI/Algorithm-specific questions:
- Sample sized used for the test set and the data provenance: N/A (this is a display monitor, not an AI algorithm evaluated on a medical image dataset).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A.
- Adjudication method for the test set: N/A.
- 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: N/A.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for a display monitor is adherence to technical specifications and display standards (e.g., DICOM GSDF).
- The sample size for the training set: N/A.
- How the ground truth for the training set was established: N/A.
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TOTOKU
KB3511
Page 1 of 4
510(k) SUMMARY
DEC 1 9 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: | November 1, 2013 |
| Device Name: | 21.3 inch (54 cm) Monochrome LCD Monitor MS25I2 (ML21025) |
| Common Name: | MS25I2, ML21025 |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Monochrome LCD Monitor MS23I2 (ML21023)(K113443) |
| Device Description: | MS25I2 (ML21025) is a 21.3-inch (54 cm) Monochrome LCDmonitor whose display resolution is 1200 x 1600 (landscape), 1600x 1200 (portrait) supporting DVI (digital visual interface) andDisplay Port. |
| Intended Use: | 21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor, MS25I2(ML21025) 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: | MS25I2 (ML21025) shares the same characteristics with ourpredicate device MS23I2 (ML21023) (K113443) except for theLCD panel and 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') $(u', v') ≤ 0.01$ measured at 80% Lmax based on AAPM-TG18 4.8.4Refer to Chromaticity actual data |
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Substantial Equivalence Compariso
| 21.3-inch (54cm) MonochromeLCD Monitor MS2312 (ML21023) | 21.3-inch (54cm) MonochromeLCD Monitor MS2512 (ML21025) | |
|---|---|---|
| 510(k) Number | K113443 | K133511 |
| Display Area | Horizontal: 324.0mm, Vertical: 432.0mmVertical: 432.0mm, Horizontal: 324.0mm | Horizontal: 324.0mm, Vertical: 432.0mmVertical: 432.0mm, Horizontal: 324.0mm |
| Input Signal | DVI-D, DisplayPort | DVI-D, DisplayPort |
| Maximum Display | 1200 x 1600 (4800 subpixel) dots at portrait display1600 (4800 subpixel) x 1200 dots at landscape display | 1200 x 1600 (4800 subpixel) dots at portrait display1600 (4800 subpixel) x 1200 dots at landscape display |
| Pixel Pitch | 0.270mm x 0.270mm | 0.270mm x 0.270mm |
| 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 Image Clock | 162 MHz | 162 MHz |
| Maximum Luminance | 1800 cd/m² | 1900 cd/m² |
| Luminance Calibration(Optional) | Software: Medivisor NxCalibration Sensor (Optional): Chroma5 (X-Rite) | Software: Medivisor NxCalibration Sensor (Optional): Chroma5 (X-Rite) |
| Contrast Ratio | 700:1 | 1400:1 |
| Serial Communication | USB: Upstream port (x 1), Downstream port (x 2) | USB: Upstream port (x 1), Downstream port (x 2) |
| Grayscale | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) |
| Safety Standard | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC(Class B), MDD/CE, VCCI-B (Class B) | |
| UL60601-1, CSA C22.2 No. 601-1, MDD/CE, FCC (ClassB), VCCI (Class B) | ||
| Weight & Dimension | Net: Approximately 10.8kg474(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: Approximately 15Kg470(W) x 670(H) x 340(D) mm | Net: Approximately 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: Approximately 15Kg470(W) x 670(H) x 340(D) mm |
| Power Supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
ML21025 (MS25i2) employs the same front bezel, back enclosure and tilt stand as predicate device MS23i2 (ML21023 Similarities: ML21025 (MS25i2) employs the same front bezel,
Differences.
M225325 (212) 486-7700
TECH POWERED BY PEOPLE
Panel and pure flowers and plants
Different employees can
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K133511
Page 4 of 4
MS25i2 (ML21025) can be considered to have equivalent display performances to those of the predicate device MS23i2 (ML21023) (K113443) due to the following reasons:
- The maximum display sizes (1200 x 1600) and the active area sizes (324.0mm (H) x a. 432.0mm (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 (1900 cd/m2) is higher than that of the predicate device (1800 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 MS25i2 (ML21025) 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 MS25i2 (ML21025) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 2M pixel Monochrome LCD Monitor. MS2512 (ML21025) 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 U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 19, 2013
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro General Manager 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
Re: K133511
Trade/Device Name: 21.3 inch (54 cm) Monochrome LCD Monitor MS25i2 (ML21025) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 1, 2013 Received: November 14, 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 (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.
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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/Resourcesfor You/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,
Smh.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)
K133511
Device Name MS25i2 (ML21025)
Indications for Use (Describe)
21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS25i2 (M1.21025) 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)
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)
Page 1 of 2
PAC Publicitume Servator 1 1413 > LL 1-67 JP EF
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§ 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).