(29 days)
The MD211C3 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. MD211C3 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, MD211C3 is a 21.3" Color LCD monitor that displays image for medical use, It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MD211C3 display, structured as requested.
Important Note: The provided document is a 510(k) summary for a medical display monitor. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a full efficacy study of a new medical algorithm or diagnostic tool. Therefore, many of the requested categories related to algorithm performance, ground truth, and human reader studies are not applicable or will have "N/A" (Not Applicable) as the MD211C3 is a display device, not an AI-powered diagnostic tool.
Acceptance Criteria and Study for MD211C3 Diagnostic Imaging LCD Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MD211C3 are primarily based on demonstrating substantial equivalence to its predicate device, the L218TL 3MP Monochrome LCD Monitor (K090215), as well as adherence to relevant medical and safety standards. The document outlines a comparison of technical specifications between the two devices.
| Feature / Standard | Acceptance Criteria (Predicate: L218TL) | Reported Device Performance (MD211C3) |
|---|---|---|
| Panel Type | 21.3" TFT Monochrome LCD Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.212 mm x 0.212mm |
| Native Resolution | 2048x1536 (Landscape), 1536x2048 (Portrait) | 2048x1536 (Landscape), 1536x2048 (Portrait) |
| Brightness | 400 cd/m² calibrated, 1450 cd/m² Max. | 400 cd/m² calibrated, 800 cd/m² Max. |
| Contrast Ratio | 900 : 1 (typical) | 1400 : 1 (typical) |
| Display Color Depth | 10-bit (1024 grey tones) with 3061 total colors | 1,073,741,824 colors |
| Intended Use | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life-support, not for digital mammography, designed for interconnection with IEC60601-1-1 certified equipment. | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life-support, not for digital mammography, designed for interconnection with IEC60601-1-1 certified equipment. (Identical) |
| Certifications & Standards (Safety/EMC/DICOM) | 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 |
| Radiation Safety | Equivalent to Predicate | Same performance as predicate (EN60601-1-2) |
| Mechanical Safety | Equivalent to Predicate | Same performance as predicate |
| Electrical Safety | Equivalent to Predicate (AAMI/ES 60601-1) | Same performance as predicate (AAMI/ES 60601-1) |
| Human Factors | Equivalent to Predicate | Same performance as predicate |
| DICOM Conformance | Equivalent to Predicate | Same performance as predicate |
2. Sample Size for Test Set and Data Provenance
This is an approval for a display monitor, not an AI algorithm or a diagnostic device that analyzes data. Therefore, the concept of a "test set" comprised of medical images or patient data, and its provenance, is not applicable. The testing would have involved engineering and performance verification tests of the monitor itself (e.g., luminance, chromaticity, resolution, stability, adherence to DICOM Part 14 grayscale standard display function, and safety standards like IEC 60601-1 and EN60601-1-2).
- Sample Size for Test Set: N/A (Not applicable for a display monitor).
- Data Provenance: N/A (No patient or image data set used in the sense of an algorithm study). Testing would typically occur in laboratory settings by engineers.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: N/A
- Qualifications of Experts: N/A
As this is a display monitor, the "ground truth" relates to its physical performance characteristics (e.g., precise measurements of brightness, contrast, color accuracy, resolution, stability, and adherence to DICOM calibration) as measured by calibrated instruments and verified against engineering specifications and industry standards. This isn't a diagnostic ground truth established by medical experts.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A
There is no "adjudication" in the context of an algorithm's output for a display monitor. Performance is measured against objective technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect size of human readers improving with AI vs without AI assistance: N/A.
This device is a display monitor, not an AI-enabled diagnostic tool; therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? No.
This device is a display monitor. It does not contain an algorithm that performs diagnostic analysis in a "standalone" fashion. Its function is to display images accurately for human interpretation.
7. Type of Ground Truth Used
The "ground truth" for a medical display monitor is defined by:
- Objective Technical Specifications: Measurements of luminance, chromaticity, resolution, uniformity, stability, and viewing angle characteristics.
- Adherence to Industry Standards: Conformance to DICOM Part 14 Grayscale Standard Display Function (GSDF) for accurate grayscale reproduction.
- Safety and EMC Standards: Compliance with standards like IEC 60601-1 (medical electrical equipment safety), EN60601-1-2 (electromagnetic compatibility), and DIN V 6868-57 (quality assurance for image display systems).
8. Sample Size for the Training Set
- Sample Size for Training Set: N/A
As a display monitor, there is no "training set" in the context of machine learning. The device is manufactured and calibrated according to established engineering principles and production controls.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: N/A
Since there is no training set for a machine learning algorithm, this question is not applicable. The display's performance characteristics (its "ground truth") are established through design specifications, calibration procedures, and adherence to international standards for medical displays.
§ 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).