(13 days)
The MD242C2 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. MD242C2 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, MD242C2 is a 24.1" Color LCD monitor that displays image for medical use, It provides 2.3 mega pixel (1920*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided text describes a 510(k) premarket notification for a medical display monitor (MD242C2 24.1" Diagnostic Imaging LCD monitor). This document focuses on demonstrating substantial equivalence to a predicate device L217TG TFT Color LCD Monitor rather than conducting a clinical study to prove performance against specific acceptance criteria for a new medical algorithm or diagnostic tool.
Therefore, many of the requested sections about clinical study design, sample sizes, expert involvement, and ground truth establishment are not applicable. The device in question is a display monitor, not an AI-powered diagnostic device or an algorithm that interprets medical images.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study assessing diagnostic performance. Instead, it compares the technical specifications and intended use of the new device (MD242C2) to a legally marketed predicate device (L217TG) to demonstrate substantial equivalence.
The "performance" is reported as its technical specifications, which are implicitly accepted if they are substantially equivalent to the predicate device.
| Items | Predicate Device (L217TG) Performance | Applicant Device (MD242C2) Performance | Implicit Acceptance Criteria (Substantial Equivalence) |
|---|---|---|---|
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 24.1" TFT Color LCD Monitor | Comparable size and type for diagnostic imaging. New device is larger, but still within acceptable medical monitor range. |
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270mm | Identical |
| Display Color | 16,777,216 | 1,073,741,824 | Improved (more colors), therefore acceptable |
| Viewing Angles (°) (H,V) | H:176, V:176 | H:178, V:178 | Improved, therefore acceptable |
| Scanning Freq. (H,V) | 31.5-91.1kHz, 50-85 Hz | 31.5-93.8, 118.4kHz, 50-85 Hz | Comparable/Improved |
| Native Resolutions | 1600X1200 | 1920X1200 | Improved (higher resolution), therefore acceptable |
| Brightness | 400 cd/m² calibrated, 850 cd/m² Max. | 180 cd/m² calibrated, 350 cd/m² Max. | Calibrated brightness is lower, but still within specifications for diagnostic monitors (DICOM conformance is mentioned). Max brightness is lower. This is deemed acceptable as the device still conforms to relevant standards (e.g., DICOM part 14, DIN V 6868-57). |
| Contrast Ratio | 1050 : 1 (typical) | 1000 : 1 (typical) | Comparable |
| DOT Clock | 162 MHz | 202.5 MHz (Max) (Analog), 162 MHz (Max) (Digital) | Comparable/Improved |
| Input Signals/Terminals | D-sub analog VGA, DVI-I (x2) | DVI port, Display port, HDMI port | Different, but modern and functionally equivalent/improved for connecting to display controllers. |
| Active Display Size (H x V) | Landscape: 432mmX324mm, Portrait: 324X432mm | Landscape: 518.4mmX324mm, Portrait: 324X518.4mm | Increased, consistent with larger panel size, therefore acceptable. |
| Viewable Image Size (diagonal) | 540 mm | 540 mm | Identical |
| Luminance Calibration | Software | Software | Identical |
| Default Gamma | DICOM part 14 + off, etc. | DICOM part 14 | Simplified to primarily DICOM part 14, but still meeting the critical standard. |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | Identical |
| Power Consumption | 100W (Max) | 38.4W (Max) | Improved (lower consumption), therefore acceptable |
| Power Save Mode |
§ 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).