(500 days)
21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) 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.
MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 6144 (landscape), 6144 x 1536 (portrait) supporting DVI (digital visual interface).
This document focuses on the 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monochrome digital mammography LCD monitor. This device is a display monitor and, as such, does not undergo the same type of performance studies (e.g., diagnostic accuracy studies with human readers, AI algorithms, and clinical outcomes) as a diagnostic imaging device or an AI-powered diagnostic algorithm.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context will refer to the technical specifications and standards that a medical display monitor must meet to be considered safe and effective for its intended use, particularly for mammography. The 510(k) summary provided here does not detail a clinical study with patients, readers, or AI algorithms; rather, it asserts substantial equivalence to predicate devices based on technical characteristics.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details, ground truth for training set) are not applicable or not provided in the context of a 510(k) for a display monitor.
Here's an interpretation based on the provided document and general understanding of medical display regulatory submissions:
Acceptance Criteria and Device Performance for TOTOKU MS31i2 (MDL2128A)
This 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monitor focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific clinical performance study with defined acceptance criteria for diagnostic accuracy. For a display monitor, acceptance criteria are typically related to its physical and performance specifications that ensure images are displayed accurately and consistently for medical diagnosis, especially in demanding fields like mammography.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the acceptance criteria are implicitly tied to the performance characteristics being equivalent to the predicate devices and meeting relevant standards for display of medical images. Specific quantitative acceptance criteria are not detailed in this summary, but the device description highlights key specifications.
| Characteristic / Acceptance Criteria (Implied) | Reported Device Performance (from K096947) |
|---|---|
| Display Resolution | 1536 x 6144 (landscape) / 6144 x 1536 (portrait) |
| Screen Size | 21.3 inch (54 cm) |
| Display Type | Monochrome LCD |
| Sub-pixel Driving Technique | Enables 9M subpixels to be driven independently |
| Interface | Supports DVI (Digital Visual Interface) |
| Intended Use | Displaying and viewing medical images for diagnosis by trained medical practitioners in digital mammography PACS and modalities (including FFDM). |
| Equivalence to Predicate Devices | Shares the same characteristics with ME551i2 (K061447) and MS51i2 (K071794) |
Study to Prove Acceptance Criteria:
The "study" to prove the device meets acceptance criteria in this context is the substantiation of substantial equivalence to legally marketed predicate devices, ME551i2 (K061447) and MS51i2 (K071794). This involves demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.
For medical display monitors, this typically involves:
- Technical Bench Testing: Verifying that the monitor meets its published specifications (e.g., luminance, contrast ratio, uniformity, color stability for color displays, resolution, grayscale reproduction accuracy according to DICOM Part 14 standard).
- Compliance with Standards: Demonstrating adherence to relevant industry and regulatory standards for medical devices and displays (e.g., DICOM Part 14, IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).
- Comparison to Predicate Device Specifications: A direct comparison of the technical specifications of the new device against the predicate device to establish equivalence.
The 510(k) summary itself states: "MS31i2 (MDL2128A) shares the same characteristics with our predicate device ME551i2 (K061447) and MS51i2 (K071794)." This statement is the core of the "proof" from the regulatory perspective provided in this document.
Regarding the specific questions that are not directly applicable to a display monitor 510(k) from the provided text:
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 device is a display monitor, not a diagnostic algorithm or imaging system that processes patient data. The "test set" would refer to a set of technical tests on the display hardware itself, not a dataset of patient images.
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. Ground truth, in the sense of clinical diagnoses or pathology, is not established for a display monitor. Technical experts and engineers would evaluate the monitor's performance against technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication is relevant for clinical studies where multiple readers interpret images.
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 device is a monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "ground truth" for a display monitor's performance would be objective measurements against technical standards (e.g., luminance measurements, spatial resolution charts, grayscale step tests), not clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is a monitor, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a monitor.
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:
K096947
P. 1 of 1
510(k) SUMMARY
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 Japan | AUG 1 6 2010 |
|---|---|---|
| Contact Person: | Mikio Hasegawa, General ManagerEmail: hasegawam@totoku.co.jpTel:+81.268.34.5469Fax:+81.268.34.5548 | |
| Date Prepared: | April 3, 2009 | |
| Device Name: | 21.3 inch (54 cm) Monochrome Digital Mammography LCD MonitorMS31i2 (MDL2128A) | |
| Common Name: | MS31i2, MDL2128A | |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 5M Monochrome Digital Mammography LCD Monitor ME551i2(MDL2116A) (K061447) and MS51i2 (MDL2123A) (K071794). | |
| Device Description: | MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCDmonitor whose display resolution is 1536 x 6144 (landscape),6144 x 1536 (portrait) supporting DVI (digital visual interface). | |
| Intended Use: | 21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCDMonitor with sub-pixel driving techniques enabling 9M subpixelsto be driven independently, MS31i2 (MDL2128A) is intended tobe used in displaying and viewing medical images for diagnosisby trained medical practitioners. It is to be used in digitalmammography PACS and modalities including FFDM. | |
| Substantial Equivalence: | MS31i2 (MDL2128A) shares the same characteristics with ourpredicate device ME551i2 (K061447) and MS51i2 (K071794) |
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MS31i2 Premarket Notification
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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
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 Oya, Ueda, Nagano 386-0192 JAPAN
AUG 1 6 2010
Re: K090947
Trade/Device Name: 21.3 inch (54cm) Monochrome Digital Mammography LCD Monitor MS31i2 (MDL2128A)
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II.
Product Code: LLZ
Dated: June 25, 2010
Received: June 29, 2010
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 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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Enclosure
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,
Sincerely, yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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INDICATIONS FOR USE
AUG 16 2010
510(k) Number: Not Known
Device Name: 21.3 inch (54cm) Monochrome Digital Mammography LCD Monitor MS31i2 (MDL2128A)
Indications for Use:
21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) 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)
(Division Sign-Off)
fice of Ir
K090947
-10K
TOTOKU ELECTRIC CO., LTD.
§ 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).