(82 days)
21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Best suited for CT and MRI, ME213L (MDL2108A) is a 21.3-inch high definition monochrome medical imaging LCD monitor with higher luminance (1500cd/m²) and longer lifetime (three times as long as our existing models). With λ-Sentinel, a luminance stabilizing circuit, mounted, ME213L (MDL2108A) delivers stable display of images.
The provided text does not contain information regarding acceptance criteria for a device, nor does it describe a study that validates device performance against such criteria. The document is a 510(k) summary and an FDA clearance letter for a medical monitor (TOTOKU 21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A)).
This type of document typically focuses on demonstrating substantial equivalence to a predicate device, rather than detailing specific performance studies with acceptance criteria in the manner you've outlined. It confirms the device's technical specifications and intended use, and states that it shares characteristics with a predicate device (MDL2004 (K021738)) with some improvements in display area, luminance, number of photo sensors, and lifetime.
Therefore, for your required information, the following answers are based on the absence of this information in the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not provided in the document.
- Reported Device Performance: The document states the device has "higher luminance (1500cd/m²)" and "longer lifetime (three times as long as our existing models)" compared to existing models, and includes a "λ-Sentinel, a luminance stabilizing circuit." However, these are descriptive features and not presented as performance "against" specific acceptance criteria in the context of a validation study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This information is typically part of a performance study, which is not detailed here.
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)
- Not applicable / Not provided. This information is typically part of a performance study, which is not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. This information is typically part of a performance study, which is not detailed here.
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 medical monitor, not an AI software/device for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a medical monitor, not an algorithm, so a standalone algorithm performance study is not relevant and was not conducted or mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. This information is typically part of a performance study, which is not detailed here.
8. The sample size for the training set
- Not applicable / Not provided. The device is a monitor, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. The device is a monitor, not a machine learning model, so there is no "training set" or associated ground truth.
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TOTOKU
510(k) SUMMARY
| K040695 | |
|---|---|
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 Japan |
| Contact Person: | Mikio Hasegawa, General ManagerEmail: hasegawam@totoku.co.jpTel:+81.268.34.5469Fax:+81.268.34.5548 |
| Date Prepared: | March 15, 2004 |
| Device Name: | 21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A) |
| Common Name: | ME213L, MDL2108A, 2M Monitor/Display |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | MDL2004 (K021738) |
| Device Description: | Best suited for CT and MRI, ME213L (MDL2108A) is a 21.3-inchhigh definition monochrome medical imaging LCD monitor withhigher luminance (1500cd/m²) and longer lifetime (three timesas long as our existing models). With λ-Sentinel, a luminancestabilizing circuit, mounted, ME213L (MDL2108A) delivers stabledisplay of images. |
| Intended Use: | 21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A)is to be used in conjunction with the picture archivingcommunication systems (PACS) for medical imaging applications.It is not meant to be used for digital mammography. |
| Substantial Equivalence: | ME213L (MDL2108A) shares the same characteristics with ourpredicate device MDL2004 (K021738) except for the panel whichis superior to the predicate device in display area, luminance,and number of photo sensors available. It also has a three-timeslonger lifetime. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K040695 Trade/Device Name: 21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 15, 2004 Received: March 17, 2004
Dear Mr. Hasegawa:
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, de nees that have been 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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 that I Dr. I has I 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ogh finding of substantial equivalence of your device to a legally premarket notification. The PDF mising of early of evice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your de of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 10. questions on and please note the regulation entitled, "Misbranding Other of Othphanos at ( votification" (21CFR Part 807.97) you may obtain. Other general by receive to premarked notified under the Act may be obtained from the Division of Small Information on your responsioner Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K040695 510(k) Number: Not Known Device Name: 21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A) Indications for Use:
21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Bartological Devices K040695
510(k, Number
§ 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).