(29 days)
The MDC212C2 Color displays are intended to be used for displaying of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers.
MDC212C2 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC 60601-1-1 certified equipment.
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1600*1200p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided document is a 510(k) premarket notification for a medical display monitor, the NEC Diagnostic Imaging Color LCD Monitor, Model MDC212C2. It aims to demonstrate substantial equivalence to a legally marketed predicate device (MD210C3).
The document is not about an AI/ML medical device. It is a traditional medical device submission for a display monitor. As such, it does not describe a study involving human readers, AI assistance, or ground truth established by experts for diagnostic performance. The "acceptance criteria" and "study" described are related to the physical and technical performance of the monitor regarding display quality and safety, not diagnostic accuracy of an AI algorithm.
Therefore, many of the requested points regarding AI/ML device study design (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC study, standalone performance) are not applicable to the content of this document.
However, I can extract information related to the acceptance criteria for this specific device and the type of testing performed to prove it meets them.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and compliance with relevant performance and safety standards for medical displays. The "performance" is reported as technical specifications and adherence to these standards.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Predicate Device (MD210C3) Specification (Implicit Acceptance Target) | Subject Device (MDC212C2) Reported Performance | Assessment / Compliance |
|---|---|---|---|
| Classification | Class II/PGY | Class II/PGY | Meets |
| Intended Use | Displaying/viewing digital images for diagnosis by trained physicians (with caveats) | Displaying/viewing digital images for diagnosis by trained physicians (with caveats) | Meets (Identical) |
| Panel Size | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor | Meets |
| Display Color | 1,073,741,824 | 1,073,741,824 | Meets |
| Luminance Calibration | Software | Software | Meets |
| Default Gamma | 1.8, 2.0, 2.2, DICOM part 14 | 1.8, 2.0, 2.2, DICOM part 14 | Meets |
| Power Input | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | Meets |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.270 mm x 0.270mm | Difference (Justified) |
| Viewing Angles | H:176, V:176 | H:89, V:89 | Difference (Justified) |
| Scanning Frequency (H, V) | 31.5-94.8, 126.3kHz, 50-85 Hz | 31.5-94.0 kHz, 50-85 Hz | Difference (Justified) |
| Native Resolutions | 2048 x 1536 | 1600 x 1200 | Difference (Justified) |
| Brightness | 400 cd/m2 calibrated, 800 cd/m2 Max. | 440 cd/m2 calibrated, 180 cd/m2 Max. | Difference (Justified) |
| Contrast Ratio | 1400 : 1 (typical) | 1500 : 1 (typical) | Difference (Justified) |
| DOT Clock | 214.3 MHz | 214.3 MHz | Meets |
| Input Signals/Terminals | DVI-D, Display Port | DVI-D (HDCP), Display Port (HDCP), 15pin Mini D-sub/VGA | Differences (Justified, additional inputs) |
| USB | No | USB Specification Revision 3.0 | Difference (Justified, added feature) |
| Active Display Size | Landscape: 433mm x325mm; Portrait: 325X433mm | Landscape: 432mm x 324 mm; Portrait: 324 X 432 mm | Minor Difference (Justified) |
| Viewable Image Size | 540 mm | 540 mm | Meets |
| Input Rating | 1.1-0.44A | 1.0 - 0.6 A | Difference (Justified) |
| Dimensions | Varied | Varied | Differences (Justified) |
| NET Weight | 11.8 kg | 8.0 kg | Differences (Justified) |
| Safety Standard Compl. | IEC 60601-1 (Implicit) | IEC 60601-1 | Meets |
| EMC Standard Compl. | IEC 60601-1-2 (Implicit) | IEC 60601-1-2 | Meets |
| Display Performance Compl. | AAPM TG 18 (Implicit) | AAPM TG 18 | Meets |
Note on "Differences": The document states that while there are differences in technological characteristics between the subject device and the predicate, "The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues." This is the core of a 510(k) submission: proving substantial equivalence despite differences.
Study Details (as applicable to a display monitor)
- Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic image data. The "test set" here refers to the single subject device unit that underwent non-clinical testing. The provenance is the manufacturer's testing data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as in diagnostic labels is not established for a display monitor. The "ground truth" for the monitor's performance is adherence to technical specifications and industry standards like IEC 60601-1, IEC 60601-1-2, and AAPM TG 18.
- Adjudication method for the test set: Not applicable. Testing involves engineering and technical verification against established standards and specifications, not human adjudication of diagnostic findings.
- 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 display monitor, not an AI diagnostic tool, and no MRMC study was performed or required.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device revolves around the fulfillment of technical specifications and compliance with recognized medical device standards (e.g., IEC 60601-1 for safety, IEC 60601-1-2 for electromagnetic compatibility, and AAPM TG 18 for display performance).
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary, the document provides evidence for the substantial equivalence of a medical display monitor to a predicate device, based on a comparison of technical specifications and adherence to relevant non-clinical performance and safety standards. It explicitly states, "The submission does not contain clinical data." and focuses on "non-clinical tests" and "design verification activities."
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, which is a symbol of medicine and healing. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
NEC Display Solutions Ltd. % Mr. David Cheng Vice Director Top Victory Electronics (Taiwan) Co., Ltd. 10F, No. 230, Liancheng Road, Zhonghe Dist. New Taipei City, 23559 TAIWAN
Re: K161057
Trade/Device Name: Diagnostic Imaging Color LCD Monitor, Model MDC212C2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 11, 2016 Received: April 14, 2016
Dear Mr. Cheng:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K161057
Device Name
Diagnostic Imaging Color LCD monitor, Model MDC212C2
Indications for Use (Describe)
The MDC212C2 Color displays are intended to be used for displaying of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers.
MDC212C2 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC 60601-1-1 certified equipment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared
April 12, 2016
2. Submitter's Information
| Name of Sponsor: | NEC Display Solutions Ltd. |
|---|---|
| Address: | 4-28, Mita 1-chome, Minato-ku,Tokyo, Japan. |
| Contact: | Mr. Satoru Kotani |
| Telephone No.: | +81-465-85-2384 |
| Fax No.: | +81-465-85-2393 |
3. Trade Name, Common Name, Classification
| Trade Name: | Diagnostic Imaging Color LCD Monitor,Model MDC212C2 |
|---|---|
| Common Name: | Color LCD Monitor, Color DiagnosticDisplay, etc. |
| Classification Name: | System, Image Processing, Radiological |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | II |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows:
| 510(k) Number | K142951 |
|---|---|
| Applicant | NEC Display Solutions Ltd. |
| Device Name | MD210C3 21.3" Diagnostic Imaging LCD monitor |
5. Description of the Device
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1600*1200p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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6. Intended Use
The MDC212C2 Color displays are intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers. MDC212C2 cannot be used for a life-support system. This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC 60601-1-1 certified equipment.
7. Technological Characteristics
MDC212C2 is a LCD display system for medical viewing, with high resolution 1600 x 1200, self-calibration, Gamma adjust, front sensor, ambient sensor calibration. There are no significant differences between subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
| Item | MDC212C2 |
|---|---|
| Name of device | MDC212C2 |
| Classifications/ code | Class II/ PGY |
| Panel Size and Type | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270mm |
| Display Color | 1,073,741,824 |
| Viewing Angles (°) | H:89, V:89 |
| Scanning Frequency(H, V) | 31.5-94.0 kHz , 50-85 Hz |
| Brightness | 440 cd/m2 calibrated,180 cd/m2 Max. |
| Contrast Ratio | 1500 : 1 (typical) |
| Input Signals | DVI-D (applicable to HDCP)Display Port (applicable to HDCP)15pin Mini D-sub |
| Input Terminals | DVI-D, Display port, VGA |
| USB (option) / Standard | USB Specification Revision 3.0 |
| Active Display Size (H x V) | Landscape: 432mm X 324 mmPortrait: 324 X 432 mm |
| Viewable Image Size | 540 mm |
| Luminance Calibration | Software |
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| Default Gamma | 1.8,2.0,2.2 DICOM part 14 |
|---|---|
| Power | AC100-240V, 50/60Hz |
| Input Rating | 1.0 - 0.6 A |
8. Substantial Equivalence
The subject device has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Design Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. We conclude that MDC212C2 is substantially equivalent to predicate devices. Comparative data is shown in Table 1.
9. Summary of Non-clinical Tests
The subject device conforms to the following standards:
- IEC 60601-1. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- o IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- AAPM TG 18. Assessment of Display Performance for Medical Imaging ● Systems
10. Clinical Tests
The submission does not contain clinical data.
11. Conclusion
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 has same intended use, technology, operation principle and technical characteristics with the predicate device(s). Based on the information and non- clinical tests provided in this premarket notification, we conclude that Diagnostic Imaging LCD monitor, Model MDC212C2 is substantially equivalent to predicate devices.
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| Item | Predicate Device K142951 | Subject device |
|---|---|---|
| Name of device | MD210C3 | MDC212C2 |
| Classifications/ code | Class II/ PGY | Class II/ PGY |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.270 mm x 0.270mm |
| Display Color | 1,073,741,824 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:89, V:89 |
| Scanning Frequency (H, V) | 31.5-94.8, 126.3kHz, 50-85 Hz | 31.5-94.0 kHz, 50-85 Hz |
| Native Resolutions | 2048 x 1536 | 1600 x 1200 |
| Brightness | 400 cd/m2 calibrated,800 cd/m2 Max. | 440 cd/m2 calibrated,180 cd/m2 Max. |
| Contrast Ratio | 1400 : 1 (typical) | 1500 : 1 (typical) |
| DOT Clock | 214.3 MHz | 214.3 MHz |
| Input Signals | DVI-DDisplay Port | DVI-D (applicable to HDCP)Display Port (applicable to HDCP)15pin Mini D-sub |
| Input Terminals | DVI-D, Display port | DVI-D, Display port, VGA |
| USB (option) / Standard | No | USB Specification Revision 3.0 |
| Active Display Size (H x V) | Landscape: 433mm x325mmPortrait: 325X433mm | Landscape: 432mm x 324 mmPortrait: 324 X 432 mm |
| Viewable Image Size | 540 mm | 540 mm |
| Luminance Calibration | Software | Software |
| Default Gamma | 1.8,2.0,2.2 DICOM part 14 | 1.8,2.0,2.2 DICOM part 14 |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Input Rating | 1.1-0.44A | 1.0 - 0.6 A |
| Dimensions (W x H x D) | W:Landscape: 467.8mmPortrait:361.6 mmH:Landscape:434.3.6-584.3mmPortrait:487.4-637.4mmD: 306 mm | W:Landscape: 466.4 mmPortrait: 359.0 mmH:Landscape: 374.6 - 524.6 mmPortrait: 484.0 - 580.0 mmD: 227.6 mm |
| NET Weight | 11.8 kg | 8.0 kg |
| Intended of use | The MD210C3 color display is | The MDC212C2 Color displays |
| intended to be used fordisplaying and viewing ofdigital images for diagnosis bytrained physicians. Toguarantee the displayperformance as specified, itmust only be used inconjunction with NECapproved display controllers.MD210C3 cannot be used for alife-support system. Thisdevice must not be used indigital mammography. Thisdevice is designed forexclusive interconnection withIEC60601-1-1 certifiedequipment. | are intended to be used fordisplaying and viewing ofdigital images for diagnosis bytrained physicians. Toguarantee the displayperformance as specified, itmust only be used inconjunction with NECapproved display controllers.MDC212C2 cannot be used fora life-support system. Thisdevice must not be used indigital mammography. Thisdevice is designed forexclusive interconnection withIEC 60601-1-1 certifiedequipment. |
Table 1. Comparative Data
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§ 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).