(35 days)
21.3 inch (54 cm) inch Monochrome Digital Mammography 3M pixel driving techniques enabling 9M sub-pixels to be driven independently. MS352 (ML21035) 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 PAC'S and modalities including FFDM.
MS35i2 (ML21035) is a 21.3 inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and DisplayPort.
The provided text is a 510(k) summary for a medical display device, the TOTOKU 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor MS35i2 (ML21035). It does not describe an AI/ML-driven device or an algorithm that requires a study to prove it meets acceptance criteria in the context of diagnostic accuracy, comparative effectiveness with human readers, or standalone algorithm performance.
This document describes a display monitor and its features, comparing it to an earlier predicate device (MS33i2, K112145) to demonstrate substantial equivalence for regulatory approval. The "study" referenced in the prompt (proving the device meets acceptance criteria) in this context refers to the validation and testing of the monitor's technical specifications and performance characteristics to ensure it is safe and effective for its intended use, particularly for displaying mammography images.
Therefore, many of the requested points related to AI/ML device studies (like sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this type of medical device submission.
However, I can extract and present the acceptance criteria and reported performance for the display monitor itself, based on the information provided, and explain why other points are not relevant.
Acceptance Criteria and Reported Device Performance (TOTOKU MS35i2 Display)
This device is a medical display monitor, not an AI/ML diagnostic algorithm. The "acceptance criteria" and "study" proving performance primarily revolve around the display's technical specifications and adherence to relevant standards for medical image display.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a display monitor are typically based on its physical and optical performance characteristics relevant to medical imaging, often benchmarked against standards like DICOM GSDF and AAPM-TG18. The document establishes substantial equivalence by comparing the proposed device (MS35i2) to a predicate device (MS33i2) and highlighting key performance metrics.
| Acceptance Criteria / Performance Metric | Predicate Device (MS33i2, ML21033) | Proposed Device (MS35i2, ML21035) | Meets Criteria? (Comparison to Predicate) |
|---|---|---|---|
| Intended Use | Displaying medical images for diagnosis in digital mammography PACS and modalities. | Displaying medical images for diagnosis in digital mammography PACS and modalities, including FFDM. | Equivalent. Specific mention of FFDM for proposed device reinforces its suitability for mammography. |
| Display Area (H x V) | 318.0mm x 423.9mm (Landscape) / 423.9mm x 318.0mm (Portrait) | 324.864mm x 433.152mm (Landscape) / 433.152mm x 324.864mm (Portrait) | Proposed device has a larger active area, but the maximum display sizes (pixel count) are the same, which is deemed not to affect safety and effectiveness. |
| Maximum Display Resolution (Sub-pixel) | 1536 x 6144 (Portrait), 6144 x 1536 (Landscape) | 1536 x 6144 (Portrait), 6144 x 1536 (Landscape) | Same (Equivalent). This is a key measure of image detail. |
| Pixel Pitch | 0.207mm x 0.207mm | 0.2115mm x 0.2115mm | Slightly larger pixel pitch in the proposed device (due to larger screen size with same pixel count). This is implicitly accepted as not affecting safety/effectiveness given the overall comparison. |
| Input Signal | DVI-D, DisplayPort | DVI-D, DisplayPort | Same (Equivalent). |
| Maximum Luminance | 1000 cd/m² | 1700 cd/m² | Higher in the proposed device. The document states "The DICOM calibrated luminance values of the both devices are the same (500 cd/m2) though the typical maximum luminance value (1700 cd/m2) is higher than that of the predicate device (1000 cd/m2)." This is presented as an improvement due to LED backlight. |
| DICOM Calibrated Luminance | 500 cd/m² (Implied, as it's stated for both as "the same") | 500 cd/m² | Same (Equivalent). Critical for medical image display standardization. |
| Luminance Calibration Software/Sensor | Medivisor Nx, Chroma5 (X-Rite) (Optional Sensor) | Medivisor Nx, Chroma5 (X-Rite) (Optional Sensor) | Same (Equivalent). Ensures consistent and accurate display calibration. |
| Contrast Ratio | 900:1 | 1400:1 | Higher in the proposed device (Improvement). |
| Grayscale | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) | Same (Equivalent). Indicates high fidelity in displaying shades of gray crucial for medical images. |
| Compliance with DICOM GSDF | Yes (by default, utilizing factory calibrated mode) | Yes (by default, utilizing factory calibrated mode) | Same (Equivalent). Adherence to this standard is fundamental for medical displays. |
| Safety Standard Compliance | UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B) | Equivalent (Updated standards referenced, but fundamental safety compliance maintained). The device was "validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers." |
| Automatic Grayscale Calibration (Front Sensor) | Yes | Yes | Same (Equivalent). Ensures maintenance of image quality without constant manual intervention. |
Note on "Acceptance Criteria" for a Device: For a display monitor, acceptance criteria are the validated performance specifications that demonstrate it is safe, effective, and suitable for its intended use. The "study" here refers to the engineering tests and validation activities (e.g., luminance response, uniformity, geometrical distortion, veiling glare, noise, chromaticity) performed by the manufacturer to ensure these specifications are met and that the device performs as expected.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of diagnostic image data. The "test set" here refers to the device itself and its components. Performance evaluations were conducted on the manufactured display unit(s).
- Data Provenance: Not applicable. This is not a study involving patient data. The "data" refers to the measured performance characteristics of the monitor hardware.
3. Number of Experts Used and Qualifications for Ground Truth
- Number of Experts: Not applicable. The "ground truth" for a display monitor's performance is established by objective physical measurements using calibration equipment and adherence to industry standards (e.g., DICOM Part 14, AAPM TG-18).
- Qualifications of Experts: Not applicable. The "experts" would be engineers and technicians performing the physical measurements and validations, rather than medical experts establishing diagnostic ground truth.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. There is no subjective human interpretation of outputs to be adjudicated. Performance is measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance, not for a standalone hardware device like a display monitor.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a display monitor, not an algorithm. Its performance is inherent in its display capabilities, not in an independent algorithm's output.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance is based on objective physical measurements and adherence to established industry-wide technical standards and specifications for medical displays (e.g., luminance, contrast, resolution, grayscale fidelity according to DICOM GSDF, uniformity, and geometrical distortion as per AAPM-TG18 guidelines). It also includes compliance with safety and EMC standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI/ML model or "training set" in the context of this device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable.
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TOTOKU
K133686
page 1 of 4
JAN - 6 2014
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: | November 29, 2013 |
| Device Name: | 21.3 inch (54 cm) inch Monochrome Digital Mammography LCDMonitor MS35i2 (ML21035) |
| Common Name: | MS35i2, ML21035 |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2(ML21033) (K112145). |
| Device Description: | MS35i2 (ML21035) is a 21.3 inch (54 cm) monochrome LCDmonitor whose display resolution is 1536 x 2048 (landscape), 2048x 1536 (portrait) supporting DVI (digital visual interface) andDisplayPort. |
| Intended Use: | 21.3 inch (54 cm) inch Monochrome Digital Mammography 3Mpixel LCD Monitor with sub-pixel driving techniques enabling 9Msubpixels to be driven independently, MS35i2 (ML21035) isintended to be used in displaying and viewing medical images fordiagnosis by trained medical practitioners. It is to be used in digitalmammography PACS and modalities including FFDM. |
| Substantial Equivalence: | MS35i2 (ML21035) shares the same characteristics with ourpredicate device MS33i2 (K112145) except for the front bezel, LCDpanel and power supply. |
JVC KENWOOD Corporation
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| Substantial Equivalence Comparison | ||
|---|---|---|
| 20.8 inch MonochromeDigital Mammography LCD MonitorMS3312 (ML21033) | 21.3 inch MonochromeDigital Mammography LCD MonitorMS3512 (ML21035) | |
| 510(k) Number | K112145 | Not Known |
| Display Area | Horizontal: 318.0mm, Vertical: 423.9mmVertical: 423.9mm, Horizontal: 318.0mm | Horizontal: 324.864mm, Vertical: 433.152mmVertical: 433.152mm, Horizontal: 324.864mm |
| Input Signal | DVI-D, DisplayPort | DVI-D, DisplayPort |
| Maximum Display | 1536 x 6144 (Sub-pixel) dots at portrait display6144 (Sub-pixel) x 1536 dots at landscape display | 1536 x 6144 (Sub-pixel) dots at portrait display6144 (Sub-pixel) x 1536 dots at landscape display |
| Pixel Pitch | 0.207mm x 0.207mm | 0.2115mm x 0.2115mm |
| Scanning Frequency | DVI46.6KHz, 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) | DVI46.6KHz, 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) |
| Maximum Image Clock | 216MHz | 216MHz |
| Maximum Luminance | 1000 cd/m² | 1700 cd/m² |
| Luminance Calibration(Optional) | Software: Medivisor NxCalibration Sensor (Optional): Chroma5 (X-Rite) | Software: Medivisor NxCalibration Sensor (Optional): Chroma5 (X-Rite) |
| Contrast Ratio | 900:1 | 1400:1 |
| Serial Communication | USB: Downstream port x 2, Upstream port x 1 | USB: Downstream port x 2, Upstream port x 1 |
| Grayscale | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) |
| Safety Standard | UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE, | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B),MDD/CE, VCCI-B (Class B) |
| Weight & Dimension | Net:Approximately 12kg474(W) x 468/530(H) x 220(D) mm (Landscape)367(w) x 522/583(H) x 220(D) mm (Portrait)Packed: Approximately 15Kg, 470(W) x 685 (H) x 345(D) | Net:Approximately 12kg474(W) x 468/530(H) x 220(D) mm (Landscape)367(w) x 522/583(H) x 220(D) mm (Portrait)Packed: Approximately 15Kg, 470(W) x 670(H) x 340(D) |
| Power Supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
.
Similarities: MS35i2 (ML21035) employs the same tilt stand and back enclosure as those of predicate device MS33i2 (ML2103)
Differences:
MS35i2 (ML21035) employs a different front bezel, LCD panel and power supply
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MS35i2 (ML21035) can be considered to have equivalent display performances to those of the predicate device MS33i2 (ML21033) (K112145) due to the following reasons:
- a. The maximum display sizes (1536*6144 (Sub-pixel)) used for the both devices are same though the active area size (324.864mm (H) x 433.152mm (V)) for MS35i2 (ML21035) is larger than that for the predicate device (318.0mm (H) x 423.9mm (V)). The size difference between both devices will not affect the safety and effectiveness of MS3512 (ML21035).
- b. The DICOM calibrated luminance values of the both devices are the same (500 cd/m2) though the typical maximum luminance value (1700 cd/m2) is higher than that of the predicate device (1000 cd/m2). The higher 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 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 an 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 MS35i2 (ML21035) 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 MS3512 (ML21035) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
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K133686
Page 4 of 4
| Display System Description | |
|---|---|
| 1. Active-Matrix Liquid-Crystal Displays (AMLCD) panel manufacturer, technologyScreen sizeand pixel pitch: | |
| Screen size: 433.152(H)mm x 324.864(V) mm at landscape display, 324.864(H)mm x433.152(V)mm at portrait display, Pixel pitch: 0.0705mm(H) (sub-pixel pitch) x 0.2115(V) atlandscape display, 0.2115mm(H) x 0.0705(V) (sub-pixel pitch) 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, QC/QA (procedures with required frequencies and actionlimits): | |
| Totoku's calibration software called "Mediviser" optimizes the display's performance usingDICOM 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 Equipment | |
| 2. Declared and actual (measured with test pattern in the screen) array size | |
| 3. Luminance response | |
| • max and min achievable luminance | |
| • max and min recommended (operational) luminance | |
| • intrinsic bit-depth of the panel | |
| • true output bit-depth by performing visual test with gradient test pattern | |
| • intrinsic luminance response at 256 digital values | |
| • conformance to a grayscale function (i.e., DICOM GSDF) at 256 digital valuesand angular dependence of such conformance | |
| 4. Angular Dependencies | |
| • angular dependency o_f luminance | |
| 5. Luminance uniformity: | |
| based on AAPM-TG18 4.4 | |
| 6. Geometrical distortion: | |
| based on AAPM-TG18 | |
| 7. Display reflectance: | |
| based on AAPM-TG18 4.2.4 | |
| 8. Noise | |
| • pixel fill factor | |
| • noise power spectrum (weiner spectrum) | |
| 9. Veiling glare: | |
| based on AAPM-TG18 4.7.4 | |
| 10. Chromaticity | |
| based on AAPM-TG18 4.8.4 |
. . . . . .
:
:
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2014
JVC KENWOOD CORPORATION % Mr. Tsukasa Tashiro General Manager 3-12, Moriya-Cho, Kanagawa-Ku Yokohama-Shi, Kanagawa 221-0022 JAPAN
Re: K133686
Trade/Device Name: 21.3 inch (54 cm) inch Monochrome Digital Mammography LCD Monitor MS35i2 (ML21035)
Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 29, 2013 Received: December 2, 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/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/Safetv/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) | K133686 |
|---|---|
| -------------------------- | --------- |
Device Name MS3512 (ML21035)
Indications for Use (Describe)
21.3 inch (54 cm) inch Monochrome Digital Mammography 3M pixel driving techniques enabling 9M sub-pixels to be driven independently. MS352 (ML21035) 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 PAC'S and modalities including FFDM.
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 |
|---|---|
| ---------------------- | ------------- |
| MS35i2 Premarket Notification | 11/484 | JVC KENWOOD Corporation |
|---|---|---|
| ------------------------------- | -------- | ------------------------- |
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (9/13)
§ 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).