(12 days)
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
RadiForce GX550 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
There are two model variations, GX550 and GX550-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX550 is Anti-Glare (AG) treatment and that of the GX550-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX550 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce GX550.
The document describes a 510(k) premarket notification for the EIZO RadiForce GX550 and GX550-AR 5MP Monochrome LCD Monitors, intended for displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners, and specially designed for breast tomosynthesis applications.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to "pre-defined criteria" but does not explicitly list them. However, it indicates that the device meets these criteria. The performance testing section outlines the measurements taken, implicitly suggesting these are the aspects against which performance was assessed. Since specific acceptance values are not provided, the table below lists the measured parameters and the statement that the device meets criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF (AAPM TG18 guideline) | Verified conformance to DICOM GSDF |
| Angular dependency of luminance response (horizontal, vertical, diagonal) | Measured and meets pre-defined criteria (stated in conclusion) |
| Luminance non-uniformity characteristics (TG18 guideline) | Measured and meets pre-defined criteria (stated in conclusion) |
| Chromaticity non-uniformity characteristics (TG18 guideline) | Measured and meets pre-defined criteria (stated in conclusion) |
| Chromaticity at center (5%, 50%, 95% maximum luminance) | Measured and meets pre-defined criteria (stated in conclusion) |
| Display reflections (specular, diffuse, haze) | Measured and meets pre-defined criteria (stated in conclusion) |
| Small-spot contrast ratio | Measured and meets pre-defined criteria (stated in conclusion) |
| Spatial resolution (Modulation Transfer Function - MTF) | Measured and meets pre-defined criteria (stated in conclusion) |
| Noise (Noise Power Spectrum - NPS) | Measured and meets pre-defined criteria (stated in conclusion) |
| Pixel aperture ratio | Measured and meets pre-defined criteria (stated in conclusion) |
| Absence of miscellaneous artifacts (TG18 guideline) | Visual check performed and meets pre-defined criteria (stated in conclusion) |
| Temporal response | Measured and meets pre-defined criteria (stated in conclusion) |
| Luminance stability | Performance data provided and meets pre-defined criteria (stated in conclusion) |
| Maximum allowed pixel defects/faults | Measured and meets pre-defined criteria (stated in conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document describes bench tests performed on the RadiForce GX550. This indicates a sample size of one device (or a small number of devices directly tested).
- Data Provenance: The tests are prospective bench tests performed on the manufactured device. The location of the testing is not explicitly stated but implies to be conducted by EIZO Corporation, based in Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a technical performance verification for a medical display, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here is the established technical specifications and performance standards (e.g., DICOM GSDF, AAPM TG18 guidelines).
4. Adjudication Method for the Test Set
Not applicable. See point 3. Bench tests are objective measurements against technical standards.
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. This submission is for a medical display monitor, not an AI-powered diagnostic tool. Therefore, an MRMC study assessing human reader performance with or without AI assistance is not relevant and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a medical display, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing is based on established technical standards and guidelines for medical displays. Specifically, the document mentions:
- DICOM GSDF (Grayscale Standard Display Function): A standardized luminance response curve for medical images.
- AAPM Task Group 18 (TG18) guideline: "Assessment of Display Performance for Medical Imaging Systems," which provides methodologies and criteria for evaluating medical display monitors.
8. The Sample Size for the Training Set
Not applicable. This device is a display monitor, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 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).