(70 days)
The RadiForce GX240 is intended to be used in displaying and viewing digital images by trained medical practitioners. The RadiForce GX240 does not support the display of mammography images for diagnosis.
The RadiForce GX240 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 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.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX240" such as "GX240-CL", a model whose backlight is Clear Base (one of tints) although the hardware design, components and labeling remain unchanged.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX240 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX240.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EIZO RadiForce GX240 monitor, structured according to your request:
Acceptance Criteria and Study for EIZO RadiForce GX240
The EIZO RadiForce GX240 is a 2MP Monochrome LCD Monitor intended for displaying and viewing digital medical images by trained medical practitioners, excluding mammography images. The submission emphasizes its substantial equivalence to the predicate device, RadiForce GS220, based on performance testing. Because this is a medical display, the acceptance criteria largely revolve around display performance standards rather than diagnostic accuracy metrics typically associated with AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria and Standard | Reported Device Performance |
|---|---|---|
| DICOM GSDF Conformance | Conformance to DICOM GSDF as specified by AAPM Task Group 18 (TG18 guideline). | The RadiForce GX240 demonstrates conformance to DICOM GSDF. (Implicitly passed, stated that "meet the pre-defined criteria"). |
| Luminance Non-uniformity | Measurement of luminance non-uniformity characteristics as specified in the TG18 guideline. | The RadiForce GX240 meets these criteria. (Implicitly passed, stated that "meet the pre-defined criteria"). |
| Chromaticity Non-uniformity | Measurement of chromaticity non-uniformity characteristics as specified in the TG18 guideline. | The RadiForce GX240 meets these criteria. (Implicitly passed, stated that "meet the pre-defined criteria"). |
| Chromaticity at Center (5%, 50%, 95% max luminance) | Measurement of chromaticity at the center of the display screen at 5%, 50%, and 95% of the maximum luminance, as specified in FDA Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions. | The RadiForce GX240 meets these criteria. (Implicitly passed, stated that "meet the pre-defined criteria"). |
| Visual Check for Artifacts | Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline. | The RadiForce GX240 meets these criteria. (Implicitly passed, stated that "meet the pre-defined criteria"). |
| Pixel Defects/Faults | Maximum number allowed for each type of pixel defects/faults as agreed with the LCD panel manufacturer. | The RadiForce GX240 meets these criteria. (Implicitly passed, stated that "meet the pre-defined criteria"). |
| Substantial Equivalence to Predicate | Display performances should be substantially equivalent to the predicate device (RadiForce GS220). | The test results showed that the RadiForce GX240 has display performances substantially equivalent to those of the predicate device, RadiForce GS220. Key equivalencies noted: same matrix size (1200x1600) and active area, same DICOM calibrated luminance (500 cd/m²), higher typical maximum luminance (1200 cd/m² vs 1000 cd/m²), DICOM GSDF compliance, same QC software, same Backlight Sensor implementation. Differences (LED backlight, DisplayPort support) were deemed not to affect image quality. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of image data for diagnostic performance. The testing was performed on the device itself (RadiForce GX240) to verify its display characteristics. It's a bench performance study of the hardware, not an evaluation of diagnostic accuracy using a dataset of medical images.
- Sample Size for Test Set: Not applicable in the typical sense of medical image evaluation. The tests were performed on one or more RadiForce GX240 monitors. The specific number of individual monitors tested is not provided, but it would likely be a small, representative sample for engineering and quality control purposes.
- Data Provenance: Not applicable. No patient data or medical images from specific countries were used for evaluation of the device's diagnostic performance. The tests involved image quality metrics generated and measured on the display.
- Retrospective or Prospective: Not applicable as no patient data was used for evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This evaluation focuses solely on the technical performance of a display device, not on diagnostic accuracy of medical images. Therefore, clinical expert ground truth for a test set of images was not required or utilized in this study. The "ground truth" for the display tests would be the specifications and standards (e.g., DICOM GSDF, TG18 guidelines).
4. Adjudication Method for the Test Set
Not applicable. As no human diagnostic performance was evaluated against a ground truth, no adjudication method like 2+1 or 3+1 was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. This type of study is designed to evaluate changes in human reader diagnostic performance (e.g., sensitivity, specificity) with and without AI assistance or different display types, which is not the scope of this submission. The submission confirms "No animal or clinical testing was performed on the RadiForce GX240."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The RadiForce GX240 is a display monitor, not an AI algorithm. Therefore, a standalone algorithm performance study was not relevant or performed.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was based on established industry standards and guidelines for medical displays:
- Expert Consensus / Industry Standards: AAPM Task Group 18 (TG18 guideline) for display performance (DICOM GSDF conformance, luminance and chromaticity non-uniformity, visual artifacts).
- Regulatory Guidance: FDA Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions (for chromaticity measurements).
- Manufacturer Specifications: Agreements with the LCD panel manufacturer regarding acceptable pixel defects/faults.
8. Sample Size for the Training Set
Not applicable. The RadiForce GX240 is a hardware display device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. The monitor is factory calibrated to comply with standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a display device. The factory calibration settings, which could be conceptually linked to "training" the display, are established based on the display's inherent physical properties and are tuned to conform to the aforementioned industry and regulatory standards.
§ 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).