(45 days)
This product is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.
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. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX540" such as "GX540-CLAR", a model whose backlight is Clear Base with an Anti-Reflective coating on the screen surface 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 the RadiForce GX540 based on the QC 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 text describes a 510(k) premarket notification for a medical display monitor, the Eizo RadiForce GX540. It focuses on demonstrating substantial equivalence to a predicate device (RadiForce GX530) rather than providing extensive details about acceptance criteria and a study proving the device meets those criteria, which would typically be found in a clinical or performance study report for an AI/software device.
However, based on the performance testing section, we can infer some details and present them in the requested format, acknowledging where information is not explicitly provided.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but rather lists "performance testing" conducted to verify the device's characteristics, especially where it differs from the predicate device (backlighting). The performance details are presented as verification of conformance to established guidelines and measurements.
| Acceptance Criteria (Inferred from Performance Testing) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF (as specified in AAPM TG18 guideline) | "Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Angular dependency of luminance response (horizontal, vertical, diagonal) | "Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Luminance non-uniformity characteristics (as specified in TG18 guideline) | "Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Chromaticity non-uniformity characteristics (as specified in TG18 guideline) | "Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Chromaticity at center of display (5%, 50%, 95% of max luminance) | "Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Display reflections (specular, diffuse, haze components) | "Measurement of display reflections including specular, diffuse and haze components" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Small-spot contrast ratio | "Measurement of small-spot contrast ratio" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Spatial resolution (expressed as MTF) | "Measurement of spatial resolution expressed as modulation transfer function (MTF)" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Noise (expressed as NPS) | "Measurement of noise expressed as noise power spectrum (NPS)" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Pixel aperture ratio | "Measurement of pixel aperture ratio" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Absence of miscellaneous artifacts on the display screen (as specified in TG18 guideline) | "Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Temporal response | "Measurement of temporal response" conducted. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Luminance stability | "Performance data on luminance stability" collected. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
| Pixel defect limits | "The maximum number allowed for each type of pixel defects/faults agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce GX540" upheld. Outcome: "None of the tests revealed behaviors inconsistent with the expected performance." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests were bench tests on the device itself, not image 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)
This information is not applicable/not provided as the tests were technical measurements of display performance characteristics, not an assessment of medical images by experts. The "visual check" of artifacts likely refers to technical personnel inspecting the display, guided by the TG18 guideline, rather than medical experts establishing a "ground truth" for patient diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The tests involved objective measurements against established technical standards (like DICOM GSDF and AAPM TG18 guidelines), not expert adjudication of diagnostic findings.
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, an MRMC comparative effectiveness study was not done. This device is a medical display monitor, not an AI or CAD system designed to assist human readers in image interpretation. The study focused on the display's technical performance characteristics.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The device is a display monitor, not an algorithm. The "standalone" performance here would refer to the monitor's technical specifications and performance, which were indeed tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to established technical standards and industry guidelines. Specifically:
- DICOM GSDF (Grayscale Standard Display Function): A standardized luminance response curve essential for consistent medical image display.
- AAPM Task Group 18 (TG18) guideline: A comprehensive set of recommendations and test patterns for assessing the performance of medical displays.
These are objective, measurable technical standards, not clinical "ground truth" derived from patient data.
8. The sample size for the training set
This information is not applicable/not provided. This is a hardware device (display monitor), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, there is no training set for a display monitor.
§ 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).