(32 days)
21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS23i2 (ML21023) 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.
MS23i2 (ML21023) 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 text describes a 510(k) premarket notification for a medical display monitor and does not concern an AI/ML device or a device that undergoes a clinical study with acceptance criteria in the typical sense of diagnostic performance metrics like sensitivity or specificity.
Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies is not applicable to this submission.
The submission is for a 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023) intended for displaying and viewing medical images for diagnosis. The nature of the device means its "performance" is primarily assessed through technical specifications and compliance with relevant standards rather than diagnostic accuracy.
Here's a breakdown of what can be extracted and why other parts are not applicable:
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A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional diagnostic sense. This device is a monitor. Its "performance" would be assessed against technical specifications (e.g., resolution, luminance, contrast, uniformity, grayscale reproduction) and compliance with industry standards (e.g., DICOM Part 14 for grayscale display function, IEC 60601-1 for electrical safety). The document does not provide a table with these technical acceptance criteria or reported performance values. It only states the display resolution (1200 x 1600 / 1600 x 1200) and that it is a monochrome 2M pixel LCD monitor.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. As this is a display monitor, there is no "test set" of medical images in the context of evaluating a diagnostic algorithm's performance. The evaluation would be based on the physical characteristics and software functionality of the monitor itself.
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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)
- Not Applicable. No ground truth establishment related to diagnostic accuracy is relevant for a medical display monitor.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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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 is a hardware device (monitor), not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm in this product that would be evaluated in a standalone capacity.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable.
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The sample size for the training set
- Not Applicable. There is no algorithm to train.
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How the ground truth for the training set was established
- Not Applicable.
Summary based on available information:
The K113443 submission for the TOTOKU MS23i2 (ML21023) monitor is a 510(k) premarket notification for a medical display device. The "study" proving it meets acceptance criteria typically involves demonstrating that the device's technical specifications and performance meet established standards for medical monitors and are substantially equivalent to a predicate device.
- Intended Use: 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.
- Predicate Device: 21.3 inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A) (K081945).
- Substantial Equivalence: The applicant states that the MS23i2 (ML21023) shares the same characteristics with its predicate device MS21i2 (K081945) except for the main board and power supply. This means the primary "study" involved comparing the technical specifications and, presumably, testing the performance aspects (like luminance, contrast, resolution, DICOM conformance) of the new device against the predicate and relevant standards.
Without further information from the full 510(k) submission, specific technical acceptance criteria and their measured values for items like luminance, uniformity, or DICOM conformance cannot be provided. However, the nature of the device means these are the types of criteria that would be assessed.
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K113443
TOTOKU
DEC 2 3 2011
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: | November 18, 2011 |
| Device Name: | 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023) |
| Common Name: | MS23i2, ML21023 |
| 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 MS21i2 (MDL2127A)(K081945) |
| Device Description: | MS23i2 (ML21023) 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, MS23i2(ML21023) 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: | MS23i2 (ML21023) shares the same characteristics with ourpredicate device MS21i2 (K081945) except for the main board andpower supply. |
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is a prominent symbol, representing the federal government, and the text clearly identifies the department.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DEC 2 3 2011
Mr. Tsukasa Tashiro General Manager TOTOKU Electric Co., Ltd. 300 Ova 386-0192 UEDA NAGANO JAPAN
Re: K113443
Trade/Device Name: 21.3 inch (54cm) Monochrome LCD Monitor MS23i2 (ML21023) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 18, 2011 Received: November 21, 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 Pastel
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: Net-known 仁川口 443
Device Name: 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023)
Indications for Use:
21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS23i2 (ML21023) 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.
Image /page/3/Picture/5 description: The image shows the words "Prescription Use" on the left side of the image. To the right of the words is a check mark above a line. 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)
(Division Sign-Off)
ation and Safety office of in
510K K113443
TOTOKU ELECTRIC CO., LTD. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 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).