(104 days)
20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with sub-pixel driving techniques enabling 9M subpixels to be driven independently, MS33i2 (ML21033) 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.
MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and DisplayPort.
This document is a 510(k) summary for a medical device called the "20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2 (ML21033)" by TOTOKU ELECTRIC CO., LTD. It's a display monitor intended for viewing medical images for diagnosis, specifically in digital mammography PACS and modalities.
Based on the provided text, the device is a monitor, not an AI/algorithm-powered diagnostic tool. Therefore, the questions related to AI performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable. The substantial equivalence is based on device characteristics rather than diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a display monitor and not a diagnostic algorithm, typical performance metrics like sensitivity, specificity, or AUC as seen in AI studies are not relevant. The substantial equivalence is based on technical specifications and intended use comparison with a predicate device.
| Acceptance Criteria (Implied by substantial equivalence) | Reported Device Performance (Implied by substantial equivalence) |
|---|---|
| Intended Use: Used in displaying and viewing medical images for diagnosis by trained medical practitioners, in digital mammography PACS and modalities including FFDM. | Device shares the same intended use as the predicate device. |
| Technical Characteristics Comparison: Similar display resolution, monochrome display, DVI and DisplayPort support. | MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor with display resolution 1536 x 2048 (landscape), 2048 x 1536 (portrait). |
| Safety and Effectiveness: Demonstrated through comparison to a legally marketed predicate device. | Substantially equivalent to the predicate device MS31i2 (MDL2128A) (K090947). Differences are in the main board, LCD panel, and power supply, which are implicitly not considered critical enough to alter fundamental safety or effectiveness for the stated intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device monitor, not a diagnostic algorithm that processes patient data. The evaluation for substantial equivalence would involve technical testing of the monitor's performance characteristics (e.g., luminance, contrast, resolution) rather than a test set of medical images with ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for diagnostic accuracy is not established for a monitor.
4. Adjudication method for the test set
Not applicable. Adjudication methods are used in studies involving diagnostic interpretations of images, which is not the primary evaluation for a display monitor.
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. The device is a monitor, not an AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a monitor, not an algorithm.
7. The type of ground truth used
Not applicable. The concept of "ground truth" as it pertains to diagnostic accuracy studies is not relevant for a display monitor's regulatory clearance. The "ground truth" for a monitor would relate to its physical specifications and imaging performance standards.
8. The sample size for the training set
Not applicable. The device is a monitor, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. The device is a monitor, not a machine learning model.
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TOTOKU
NOV - 7 2011
KI12145
510(k) SUMMARY
| Submitted Information: | TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 Japan |
|---|---|
| Contact Person: | Tsukasa Tashiro, General ManagerEmail: tasirot@totoku.co.jpTel: +81.258.24.6611Fax: +81.258.24.6617 |
| Date Prepared: | June 20, 2011 |
| Device Name: | 20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2(ML21033) |
| Common Name: | MS33i2, ML21033 |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Monochrome Digital Mammography LCD MonitorMS31i2 (MDL2128A) (K090947). |
| Device Description: | MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor whosedisplay resolution is 1536 x 2048 (landscape), 2048 x 1536(portrait) supporting DVI (digital visual interface) and DisplayPort. |
| Intended Use: | 20.8 inch Monochrome Digital Mammography 3M pixel LCDMonitor with sub-pixel driving techniques enabling 9M subpixels tobe driven independently, MS33i2 (ML21033) is intended to be usedin displaying and viewing medical images for diagnosis by trainedmedical practitioners. It is to be used in digital mammographyPACS and modalities including FFDM. |
| Substantial Equivalence: | MS33i2 (ML21033) shares the same characteristics with ourpredicate device MS31i2 (K090947) except for the main board,LCD panel and power supply. |
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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three swooping lines representing its wings and tail. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV - 7 2011
Mr. Tsukasa Tashiro General Manager TOTOKU Electronic Co., Ltd. 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K112145 Trade/Device Name: 20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2 (ML21033) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2011 Received: October 14, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: Not known
. :
Device Name: 20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2 (ML21033)
Indications for Use:
20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS33i2 (ML21033) 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.
Image /page/3/Picture/5 description: The image shows the words "Prescription Use" next to a check mark. The check mark is large and black, and it is placed to the right of the words. The words are in a smaller font and are in black as well. The check mark indicates that the prescription use option has been selected.
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mamy Patil
Divisio Office of In Vitro Diag
510K K112145
§ 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).