(57 days)
5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) 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.
MDL2116A (ME551i2) is a 21.3-inch 5 megapixel monochrome LCD monitor whose display resolution is 2048 x 2560 (QSXGA), supporting DVI (digital visual interface).
The provided text is related to a 510(k) submission for a medical device, specifically a "5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2)". This document, however, does not contain a detailed study design or acceptance criteria for a device that uses an algorithm or AI. Instead, it's a regulatory submission for a display monitor that practitioners use to view medical images, including those from digital mammography.
Therefore, many of the requested items, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth, are not applicable to this type of device. These are typically relevant for AI/ML-driven diagnostic devices or advanced image processing software that generate a clinical output, not for a display monitor.
The document primarily focuses on establishing substantial equivalence to a predicate device (ME511L (K0417337)) based on its technical specifications and intended use.
Here's an attempt to address the relevant points based on the provided text, and explicitly state where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or performance metrics in a table format as would be expected for a diagnostic algorithm. The "reported device performance" for a monitor like this would typically involve technical specifications related to display quality, resolution, luminance, uniformity, and adherence to display standards for medical imaging (e.g., DICOM Part 14). While these are not detailed here, the statement of "Substantial Equivalence" implies that these performance aspects are at least comparable to the predicate device.
| Acceptance Criteria (Implied / Not Explicitly Stated for this Device Type) | Reported Device Performance (Implied from Substantial Equivalence and Device Description) |
|---|---|
| Display Resolution | 2048 x 2560 (QSXGA) |
| Display Type | 21.3-inch 5 megapixel monochrome LCD monitor |
| Connectivity | Supporting DVI (digital visual interface) |
| Intended Use | Displaying/viewing medical images for diagnosis, including digital mammography PACS and FFDM. |
| Substantial Equivalence to Predicate | Same characteristics as ME511L (K041737) except for board, power supply, and front sensor. |
2. Sample size used for the test set and the data provenance
Not Applicable. This is a hardware display monitor. There is no "test set" of medical images in the context of evaluating an algorithm's performance. The evaluation would involve technical testing of the monitor's display characteristics, not an analysis of a dataset of medical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As above, there is no "ground truth" establishment for a test set of medical images in the context of this device. The assessment is technical verification of monitor specifications and image display capabilities.
4. Adjudication method for the test set
Not Applicable. No test set of medical images requiring adjudication.
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. This is a display monitor, not an AI or algorithm-driven diagnostic device. MRMC studies are used to evaluate the impact of a new diagnostic method (often involving AI) on human reader performance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not Applicable. This device is a display monitor and does not involve an algorithm or AI that operates in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No ground truth needed for a clinical study comparing an algorithm's performance. The "truth" for a monitor is its technical specifications meeting established display standards.
8. The sample size for the training set
Not Applicable. This is a hardware monitor; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not Applicable. No training set exists for this device.
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TOTOKU
JUL 2 1 2006
510(k) SUMMARY
| 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: | May 23, 2006 | |
| Device Name: | 5M Monochrome Digital Mammography LCD Monitor MDL2116A(ME551i2) | |
| Common Name: | MDL2116A, ME551i2 | |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 5M Monochrome Digital Mammography LCD Monitor ME511L(MDL2105A) (K041737) | |
| Device Description: | MDL2116A (ME551i2) is a 21.3-inch 5 megapixel monochromeLCD monitor whose display resolution is 2048 x 2560 (QSXGA),supporting DVI (digital visual interface). | |
| Intended Use: | 5M Monochrome Digital Mammography LCD Monitor MDL2116A(ME551i2) is intended to be used in displaying and viewingmedical images for diagnosis by trained medical practitioners. It isto be used in digital mammography PACS and modalities includingFFDM. | |
| Substantial Equivalence: | MDL2116A (ME551i2) shares the same characteristics with ourpredicate device ME511L (K041737) except for a board, powersupply, and newly-developed front sensor. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 Oya, Ueda Nagano 386-0192 JAPAN
JUL 21 2006
Re: K061447
Trade/Device Name: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 23, 2006 Received: May 25, 2006
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, 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 either class II (Special Controls) or class III (Premarket Approval), 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.
Image /page/1/Picture/10 description: The image shows a logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with text around the perimeter and the letters "FDA" in the center. Below the letters are the words "Centennial" and three stars. The text "coting Public" is also visible at the bottom of the image.
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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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
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
Kob 1447 510(k) Number: Not Known Device Name: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) Indications for Use:
5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551i2) 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.
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)
David A. Lippman
vision of Reproductive, Abdominal, and Radiological Devices 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).