(171 days)
The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
The RadiForce RX840-MG is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. With the matrix size (or resolution) of 4.096 x 2.160 pixels (8MP), the RX840-MG is an alternate replacement for traditional dual head 5MP display installations.
Here's a breakdown of the acceptance criteria and study information for the EIZO RadiForce RX840-MG, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from TG18 guideline & pre-defined) | Reported Device Performance (RadiForce RX840-MG) |
|---|---|
| Conformance to DICOM GSDF | Met criteria (Test results showed conformance) |
| Angular dependency of luminance response (horizontal, vertical, diagonal) | Measured and found to be equivalent to predicate device, with differences not affecting observer performance. |
| Luminance non-uniformity characteristics | Measured and found to be equivalent to predicate device, with differences not affecting observer performance. |
| Chromaticity non-uniformity characteristics | Measured and found to be equivalent to predicate device, with differences not affecting observer performance. |
| Chromaticity at center of display (5%, 50%, 95% max luminance) | Measured. Specific results not detailed but implied to meet criteria or not affect observer performance. |
| Display reflections (specular, diffuse, haze) | Measured. Specific results not detailed but implied to meet criteria or not affect observer performance. |
| Small-spot contrast ratio | Measured. Specific results not detailed but implied to meet criteria or not affect observer performance. |
| Spatial resolution (Modulation Transfer Function - MTF) | Measured. Specific results not detailed but implied to meet criteria or not affect observer performance. |
| Noise (Noise Power Spectrum - NPS) | Measured. Specific results not detailed but implied to meet criteria or not affect observer performance. |
| Pixel aperture ratio | Measured. Specific results not detailed but implied to meet criteria or not affect observer performance. |
| Absence of miscellaneous artifacts | Visually checked and met criteria (No mention of artifacts affecting performance). |
| Temporal response | Measured. Specific results not detailed but implied to meet criteria or not affect observer performance. |
| Luminance stability | Performance data on luminance stability reviewed. Implied to meet criteria or not affect observer performance. |
| Maximum allowed pixel defects/faults (agreed with panel manufacturer) | Met criteria (Implied, as the device was deemed substantially equivalent). |
Note: The document explicitly states: "The test results showed that the RadiForce RX840-MG has display characteristics equivalent to those of the predicate device, RadiForce GX530 except 4 items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX840-MG meet the pre-defined criteria when criteria are set." The specific 4 items and their exact deviation are not detailed, but the overall conclusion is that any differences do not negatively impact performance or safety.
Study Details
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Sample Size used for the test set and the data provenance:
- The study involved bench testing of the RadiForce RX840-MG display monitor.
- The "test set" in this context refers to the physical device itself and its components, not a dataset of medical images or patient data.
- Data provenance: Not directly applicable as this is a device performance test, not a clinical study with patient data. The device itself is manufactured by EIZO NANAO CORPORATION in Japan.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a bench test of a display monitor, not a study requiring expert readers to establish ground truth for medical diagnoses.
- The "ground truth" was established by objective measurements against established technical guidelines (AAPM Task Group 18, DICOM GSDF) and pre-defined criteria. There is no mention of human experts being used to establish ground truth for the test set itself.
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Adjudication method for the test set:
- Not applicable. As a bench test of a display monitor, there was no adjudication of discrepant readings or interpretations. The performance was measured directly.
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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:
- No, a MRMC comparative effectiveness study was not done.
- This submission is for a medical display monitor, not an AI-powered diagnostic tool. The purpose was to show the display's technical performance characteristics.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the testing was effectively a "standalone" performance evaluation of the monitor itself, without any human interaction influencing the measurement of its technical specifications. However, it's not an "algorithm-only" performance as it's a hardware device. The device's performance was evaluated independently against technical standards.
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The type of ground truth used:
- Technical Benchmarks and Standards: The ground truth was based on established quality control guidelines and standards for medical displays, specifically:
- DICOM GSDF (Grayscale Standard Display Function)
- AAPM Task Group 18 (TG18 guideline)
- Pre-defined criteria set by the manufacturer for various display characteristics.
- Technical Benchmarks and Standards: The ground truth was based on established quality control guidelines and standards for medical displays, specifically:
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The sample size for the training set:
- Not applicable. This is a bench test for a hardware device, not a machine learning model that requires a training set. The device itself is manufactured, not "trained."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a hardware 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).