(29 days)
The Dome® GX4MP Color Monitor is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
The Dome® GX4MP Color Monitor is a 30-inch 4 megapixel Color flat-panel AMLCD-TFT monitor for use with IBM PC or PC compatible computers for widescreen imaging. The combination of high resolution and high contrast ratio allow the viewing of color and grayscale images simultaneously. Bezel-free framing of 4 megapixels of data is presented in a landscape resolution of 2560 x 1600 pixels. Gamma correction is achieved on this true color display from a palette of 1,786 near-gray values. The integrated Dome RightLight Controller monitors and stabilizes backlight luminance. The display unit includes a PCI Express graphics board to support the required duallink connectivity for the display.
The provided text is a 510(k) summary for a medical display monitor, the Dome® GX4MP Color Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study for acceptance criteria of an AI/algorithm-based device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document, as it pertains to the regulatory submission for a display monitor, not an AI or algorithm.
However, I can extract the following relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of a performance study for an algorithm. Instead, it presents a comparison of technological characteristics between the new device (Dome GX4MP) and a predicate device (Dome E4c) to demonstrate substantial equivalence. The "performance" in this context refers to the specified features of the device:
| Characteristic | Prior Approved Device (Dome E4c) | New Device (Dome GX4MP) |
|---|---|---|
| Product Model Name | Dome E4c | Dome GX4MP |
| Intended Use | To be used in displaying and viewing medical images for review and analysis by trained medical practitioners. | Unchanged (Same as predicate) |
| Display Characteristics | 4MP 2560x1600 pixel display, 16 million colors, 1786 shades of near-gray values, Factory DICOM calibrated, 370 cd/m2 IPS technology, 700:1 contrast ratio, 170 degree viewing angle | Unchanged (Same as predicate) |
| Power Supply | External IEC/EN 60601-1 power supply. | Internal IEC/EN 60950 power supply. |
| Location for Use | Radiology reading room. Not intended or marketed for near-patient use. | Unchanged (Same as predicate) |
| Enclosure | Laser-cut sheet metal back. Metal and glass bezel. | Molded plastic back and bezel. Integrated USB hub. |
The acceptance criterion, implicitly, is that the new device's key performance characteristics (display resolution, color depth, DICOM calibration, luminance, contrast, viewing angle, and intended use) are "unchanged" or demonstrably equivalent to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document because it is for a display monitor, not an algorithm that processes data or images.
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)
This information is not applicable and not provided as there is no "test set" or "ground truth" in the context of an algorithmic performance study for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. MRMC studies are used for evaluating the impact of AI on human reader performance, which is not relevant for a display monitor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a display monitor, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided.
8. The sample size for the training set
This information is not applicable and not provided. The device is hardware (a display monitor), not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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).