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510(k) Data Aggregation
(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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