(15 days)
The MD322C8 color display is 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 for in Conjunction with NEC approved display controllers. MD322C8 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 IEC60601-1-1 certified equipment.
Medical Display, MD322C8 is a 31.5" Color LCD monitor that displays image for medical use. It provides 3840*2160p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
This document is a 510(k) summary for the NEC Display Solutions MD322C8 31.5" Color LCD Monitor, intended for medical diagnostic imaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device (MD210C3). Therefore, it does not contain a comprehensive description of acceptance criteria met through a standalone study with detailed clinical performance metrics, expert reviews, and sample sizes as typically seen for AI/ML-driven medical devices.
However, based on the provided text, I can extract information related to display performance testing and a comparison to a predicate device.
Here's the breakdown of the information requested, with observations based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present quantitative acceptance criteria in a table format with corresponding quantitative device performance results for all tests. It lists specific "Display Testing" categories and then summarizes the outcome qualitatively.
| Acceptance Criteria Category (Implied by Test) | Reported Device Performance (Qualitative) |
|---|---|
| Display Reflection | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." (This statement applies to all listed display tests) |
| Luminance Response | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Luminance Uniformity | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Display Resolution | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Display Noise | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Veiling Glare | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Display Chromaticity | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| Miscellaneous Tests | "Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14." |
| DICOM Conformance | The device conforms to "DICOM part 14" (stated in the comparison table indirectly and explicitly in the summary). Performance was within the acceptable range of DICOM part 14. |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of clinical cases or patient data, as this is a display monitor. The "test set" would refer to the specific unit(s) of the MD322C8 monitor that underwent the listed "Display Testing." The document does not specify the number of monitors tested.
Data provenance is not applicable in the context of this device (a monitor). The tests are performance evaluations of the hardware itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in this context, would involve objective measurements of display characteristics against established technical standards (like DICOM part 14), rather than expert interpretation of medical images. The testing relies on instrumentation and adherence to technical specifications.
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for subjective human interpretations, especially in clinical studies or expert consensus. The testing of a display monitor against technical standards does not involve such human-based 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
No. This document pertains to a medical display monitor, not an AI/ML diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
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 with standalone performance. Its function is to accurately render images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the display tests would be established technical standards and specifications, such as DICOM Part 14 for grayscale display function and other industry standards for display performance metrics (e.g., luminance, chromaticity, resolution). These are objective, measurable standards, not medical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is a display monitor, not a machine learning model, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
February 6, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NEC Display Solutions Ltd % Mr. Tony Hsu Prodigy Technology Consultant Co., Ltd. 1F, No. 181, Sec 2, Wunhua 1st Road, Linkuo, New Taipei City, 24447 TAIWAN
Re: K150145
Trade/Device Name: 31.5 inch Color LCD Monitor MD322C8 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 15, 2015 Received: January 22, 2015
Dear Mr. Hsu:
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 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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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/Resourcesfor You/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,
Robert A Ochs
Robert Ochs, Ph.D. Acting 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) K150145
Device Name Medical Display, MD322C8
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The MD322C8 color display is 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 for in
Conjunction with NEC approved display controllers.
MD322C8 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 IEC60601-1-1 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 of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
- Mr. Satoru Kotani Manager NEC Display Solutions Ltd. 4-28, Mita 1-chome, Minato-ku, Tokyo, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393
2. COMPANY REISTRATION NUMBER
3003623028
DATE SUMMARY PREPARED 3.
15th January 2015
4. DEVICE NAME
| Trade Name: | MD322C8 31.5" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD322C8 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR892.2050) |
| Product Code: | PGY |
PREDICATE DEVICE 4.
MD210C3 3MP Color LCD Monitor by NEC Display Solutions Ltd. (K142951)
ട. DEVICE DESCRIPTION
Medical Display, MD322C8 is a 31.5" Color LCD monitor that displays image for medical use. It provides 3840*2160p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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DEVICE OF INTENDED USE 6.
The MD322C8 color display is 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.
MD322C8 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 IEC60601-1-1 certified equipment.
7. SE Comparison Table:
| Items | MD210C3 | MD322C8 |
|---|---|---|
| 510(k) Number | K142951 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 31.5" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.182 mm x 0.182mm |
| Display Color | 1,073,741,824 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:178, V:178 |
| Scanning Frequency (H, V) | 31.5-94.8, 126.3kHz, 30, 50-85 Hz | 31.5-133.2kHz, 24-87 Hz |
| Native Resolutions | 2048X1536 (Landscape)1536X2048 (Portrait) | 3840X2160 (Landscape)2160X3840 (Portrait) |
| Brightness | 400 cd/m2 calibrated,800 cd/m² Max. | |
| Contrast Ratio | 1400 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 214.3 MHz | 214.3 MHz |
| Input Signals | Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP | Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP |
| Input Terminals | DVI-D, Display port | DVI-D, Display port |
| USB (option) / Standard | No | No |
| Active Display Size (H xV) | Landscape: 433mmX325mmPortrait: 325X433mm | Landscape: 697.9mmX392.6mmPortrait: 392.6X697.9mm |
| Viewable Image Size | 540 mm (diagonal) | 801 mm (diagonal) |
| 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 | 1.51-0.6A |
| Power Save Mode | <2W | <5W |
| Dimensions(W x H x D) | W:Landscape: 473mmPortrait:373.4 mmH:Landscape:393.6-543.6mmPortrait:490.6-593.4mmD: 235.5 mm | W:Landscape: 744.8mmPortrait:440.8 mmH:Landscape:463.4-613.4mmPortrait:707.1-737.0mmD: 301.6 mm |
| NET Weight | 11.8 kg | 17 kg |
| Intended of use | Displaying and viewing of digitalimages for diagnosis by trainedphysiciansThis device can not use for a lifesupport system.This device must not be use indigital mammography.This device is designed forexclusive interconnection withIEC60601-1-1certified equipment | Displaying and viewing ofdigital images for diagnosis bytrained physiciansThis device can not use for a lifesupport system.This device must not be use indigital mammography.This device is designed forexclusive interconnection withIEC60601-1-1certifiedequipment |
| Certifications &Standards | CE ITE/Medical Device Directive,UL/cUL (ANSI/AAMI ES60601-1:2005), FCC Class B,EN60601-1-2, DIN V 6868-57,DICOM | CE ITE/Medical DeviceDirective, UL/cUL(ANSI/AAMI ES60601-1:2005), FCC Class B,EN60601-1-2, DIN V 6868-57. |
Comparison tables between MD210C3 & MD322C8
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Display Testing:
- ・ Display Reflection
- Luminance Response
- ・ Luminance Uniformity
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- Display Resolution
- ・ Display Noise
- Veiling Glare
- ・ Display Chromaticity
- Miscellaneous Tests
Summary: Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14.
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CONCLUSION
-
- These two devices have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (AAMI/ES 60601-1) human factors and DICOM conformance. It use similar material, and have same compatibility with environment and other device. The SE Comparison Table compares the principal characteristics of two devices. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MD210C3 by NEC Display Solutions Ltd. (K142951)
§ 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).