(21 days)
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
RadiForce GX540 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, GX540-CL and GX540-CLAR (GX540 without any suffix does not exist). The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX540-CL is Anti-Glare (AG) treatment and that of the GX540-CLAR is Anti-Reflection (AR) coating. The suffix common to the both variations, " - CL", means that the tint of the backlight is Clear Base (vs. Blue Base, another popular tint slightly bluish).
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX540 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX540.
The provided document is a 510(k) premarket notification for the EIZO RadiForce GX540 5MP Monochrome LCD Monitor. This document is a submission to the FDA for a medical display device, not an AI/ML-driven diagnostic device. Therefore, many of the requested criteria often associated with AI/ML device studies (such as sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or typically reported in this type of submission for a display monitor.
However, I can extract and present the available information related to acceptance criteria and performance testing for this device.
Acceptance Criteria and Reported Device Performance
Device: EIZO RadiForce GX540 5MP Monochrome LCD Monitor
| Acceptance Criteria / Specification | Reported Device Performance (EIZO RadiForce GX540) | Predicate Device Specification (Barco MDMG-5221) |
|---|---|---|
| Resolution / Matrix Size | 5MP (2,048 x 2,560) | 5MP (2,048 x 2,560) |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT (Monochrome) AMLCD Dual Domain IPS WideView |
| Backlighting | LED | CCFL |
| Maximum Luminance | 1,200 cd/m² | 2,100 cd/m² |
| DICOM Calibrated Luminance | 500 cd/m² | 1,000 cd/m² |
| Viewing Angle (H, V) | H: 176°, V: 176° | 176° |
| Active Screen Size | 337.9 mm x 422.4 mm | 337.9 mm x 422.4 mm |
| Aspect Ratio | 4:5 | 4:5 |
| Pixel Pitch | 0.165 mm x 0.165 mm | 0.165 mm x 0.165 mm |
| Contrast Ratio | 1200:1 | 950:1 |
| Grayscale Tones | 10-bit (DisplayPort): 1,024 from a palette of 16,369 tones; 8-bit: 256 from a palette of 16,369 tones | Number of grayscales (LUT in/LUT out): 1024 gray levels (10/12) |
| Non-Uniformity Compensation | Digital Uniformity Equalizer (DUE) | Per Pixel Uniformity |
| Response Time (typical) | 25 ms (On/Off) | 15 ms (Tr + Tf) |
Study Proving Acceptance Criteria:
The device's performance was evaluated through Bench Testing and Clinical Testing.
The bench tests were performed following instructions in the "Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions" and the AAPM Task Group 18 (TG18 guideline) for assessing display performance.
The clinical testing aimed to assess the image quality of tomosynthesis images on the proposed device compared to the predicate device.
Additional Requested Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Bench Testing: No sample size is explicitly stated for images or data sets. The tests are focused on the physical characteristics and performance of the monitor itself (e.g., luminance, contrast, resolution, temporal response).
- Clinical Testing: The document states the goal was to "assess the image quality of tomosynthesis images," but it does not specify the number of images or cases used for this assessment. The data provenance (country of origin, retrospective/prospective) is also not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Testing: Ground truth is not applicable in the traditional sense for these technical display measurements. The "pre-defined criteria" for bench tests are based on established guidelines (FDA Guidance, TG18).
- Clinical Testing: The document states the clinical testing evaluated "viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images." This implies evaluation by medical practitioners, but the number or qualifications of these "trained medical practitioners" who assessed the images are not mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified or applicable for either the bench or clinical testing described.
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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:
- An MRMC study was done in the sense that medical practitioners evaluated images on the proposed device versus the predicate device. However, this study was not an AI-assisted study. It was a comparison of display monitors. The document states: "The results of the testing indicated that the proposed device is at least equivalent to the predicate device for viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images." No effect size related to AI assistance is applicable or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical display monitor for human viewing, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Testing: The ground truth is the physical measurement against set technical standards (e.g., DICOM GSDF, TG18 guidelines).
- Clinical Testing: The "ground truth" implicitly relies on the subjective assessment of image quality by "trained medical practitioners" for identifying lesions. No objective ground truth like pathology or outcomes data is mentioned as being used to validate these visual assessments in the clinical test.
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The sample size for the training set:
- Not applicable. This is a display monitor, not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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).