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510(k) Data Aggregation
(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 | <2W | <2W | Identical |
| Dimensions (W x H x D) | (Various, see table) | (Various, see table) | Different due to larger panel, but within reasonable limits for a medical display. |
| NET Weight | 10.7 kg | 10.2 kg | Comparable |
| Intended Use | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support / digital mammography. Interconnect with IEC60601-1. | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support / digital mammography. Interconnect with IEC60601-1-1. | Identical. Note updated IEC standard. |
| Certifications & Standards | CE ITE/Medical Device, 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, UL/cUL (ANSI/AAMI ES 60601-1:2005), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM | Updated standard for UL/cUL (ANSI/AAMI ES 60601-1:2005), functionally equivalent and up-to-date. Otherwise identical. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a technical comparison for substantial equivalence of a display monitor, not a clinical study involving a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for patient images is not relevant for this device submission as it is not a diagnostic algorithm. The "truth" for the device is its adherence to technical specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set of patient cases 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
Not applicable. This is a display monitor, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is primarily its adherence to relevant technical standards and regulations (e.g., DICOM part 14, IEC60601-1-1, EN60601-1-2, DIN V 6868-57), and the established performance of the predicate device. The comparison table directly serves as the evidence that the new device meets or exceeds these "ground truths" in most aspects or remains substantially equivalent in critical ones.
8. The sample size for the training set
Not applicable. This is a display monitor, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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