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510(k) Data Aggregation
(29 days)
The MD211C2 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.
MD211C2 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, MD211C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1.9 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
This document describes a medical device called the MD211C2, a 21.3" Color LCD monitor intended for displaying and viewing digital images for diagnosis by trained physicians. The submission (K130772) from NEC Display Solutions Ltd. seeks to establish substantial equivalence to a predicate device, the L217TG. The study provided focuses on demonstrating equivalence through a comparison of technical specifications, rather than a clinical performance study with acceptance criteria in the typical sense for an AI/CADe device.
Here's an analysis based on the provided text, outlining what's available and what's not given the nature of the device (a display monitor):
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present specific acceptance criteria in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's a display monitor, not a diagnostic algorithm. Instead, it relies on demonstrating that the new device's technical specifications are comparable to or improved over a legally marketed predicate device. The "acceptance criteria" can be inferred as matching or exceeding the performance characteristics of the predicate device (L217TG).
| Feature / Criterion (Implied Acceptance) | Predicate Device (L217TG) Performance | Subject Device (MD211C2) Performance |
|---|---|---|
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270mm |
| Display Color | 16,777,216 | 1,073,741,824 (Improved) |
| Viewing Angles (°) | H:176, V:176 | H:176, V:176 |
| Scanning Frequency (H, V) | 31.5-91.1kHz , 50-85 Hz | 31.5-74.5, 99.4kHz, 50-85 Hz (Slight difference, still within range) |
| Native Resolutions | 1600X1200 | 1600X1200 |
| Brightness (calibrated) | 400 cd/m2 | 400 cd/m2 |
| Brightness (Max) | 850 cd/m2 | 900 cd/m2 (Improved) |
| Contrast Ratio | 1050 : 1 (typical) | 1400 : 1 (typical) (Improved) |
| DOT Clock | 162 MHz | 165 MHz (Slight difference, still comparable) |
| Input Signals | Three connectors: one D-sub analog VGA; and two DVI-I (VGA analog or digital) | Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP) (Different but equivalent modern interfaces) |
| Luminance Calibration | Software | Software |
| Default Gamma | 1.8,2.0,2.2 DICOM part 14 + off, user | 1.8,2.0,2.2 DICOM part 14 (Slight difference: "off, user" removed, but core DICOM support remains) |
| Intended Use | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support/digital mammography. Interconnect with IEC60601-1-1 certified equipment. | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support/digital mammography. Interconnect with IEC60601-1-1 certified equipment. (Identical) |
| Certifications & Standards | CE ITE/Medical Device Directive, UL/cUL (UL60601-1, CSA C22.2 No.601-1), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM | CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM (Updated UL/cUL standard, otherwise comparable) |
The study essentially is the comparison table provided, demonstrating that the MD211C2 is technically equivalent or superior to the L217TG across critical display specifications and meets relevant safety and performance standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is not a study assessing diagnostic performance on a dataset of patient images. It's a technical comparison of a hardware device.
- Data Provenance: Not applicable. The "data" here refers to the specifications and performance measurements of the display monitors themselves, not patient data.
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 the context of diagnostic interpretation, is not relevant for evaluating a display monitor's technical specifications.
4. Adjudication method for the test set:
- Not applicable. There is no diagnostic test set 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:
- No, a MRMC study was not done. This device is a display monitor, not an AI or CADe system. There is no AI component involved, so no improvement statistics for human readers are relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is a display monitor, not an algorithm.
7. The type of ground truth used:
- Not applicable. Ground truth for diagnostic interpretations is not relevant. The "ground truth" for this device's performance relies on engineering specifications, measurements, and adherence to established standards (e.g., DICOM, IEC).
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning algorithms requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth for it to be established.
Summary of the Study:
The study presented is a technical comparison between the proposed device (MD211C2) and a legally marketed predicate device (L217TG). It primarily relies on a comparative table of specifications and certifications to demonstrate substantial equivalence. The conclusion drawn is that both devices share the same intended use, design, performance, and safety characteristics (radiation, mechanical, electrical, human factors, DICOM conformance), and utilize similar materials and environmental compatibility. This comparison allows the manufacturer to assert that the MD211C2 is substantially equivalent to the predicate device, enabling its market clearance under 510(k).
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