(22 days)
This product is intended to be used in displaying digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
RadiForce RX250 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1,200 x 1,600 pixels (2MP),
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 "RX250" such as "RX250-AR", a model with an Anti-Reflective coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX250 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 RX250.
The provided FDA 510(k) summary for the EIZO RadiForce RX250 and RX250-AR 2MP Color LCD Monitor describes the acceptance criteria and the study performed to demonstrate its performance.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside performance for each individual test in a clear, side-by-side format. However, it lists several performance tests and states that the device "meet the pre-defined criteria when criteria are set" and that its display characteristics are "equivalent to those of the predicate device, RadiForce RS240."
Based on the descriptions, we can infer some criteria and implied performance:
| Acceptance Criteria Category | Implied/Inferred Specific Criteria (based on tests) | Reported Device Performance |
|---|---|---|
| DICOM Conformance | Conformance to DICOM GSDF as specified by AAPM TG18 guideline | The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Verification of the conformance to DICOM GSDF...") |
| Luminance Uniformity | Non-uniformity characteristics as specified in TG18 guideline | The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of the luminance non-uniformity characteristics of the display screen...") |
| Chromaticity Uniformity | Non-uniformity characteristics as specified in TG18 guideline | The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of the chromaticity non-uniformity characteristics of the display screen...") |
| Chromaticity Accuracy | Chromaticity at 5%, 50%, and 95% of maximum luminance within acceptable range | The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance") |
| Visual Artifacts | Absence of miscellaneous artifacts on the display screen as specified in TG18 guideline | The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Visual check of presence or absence of miscellaneous artifacts on the display screen...") |
| Spatial Resolution (MTF) | Meeting specified Modulation Transfer Function (MTF) criteria | The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "Measurement of spatial resolution expressed as modulation transfer function (MTF)") |
| Pixel Defects/Faults | Maximum number allowed for each type of pixel defects/faults | The test results showed that the RadiForce RX250 has display characteristics equivalent to those of the predicate device, RadiForce RS240, and meets pre-defined criteria. (Specifically mentioned: "The maximum number allowed for each type of pixel defects/faults") |
| Overall Equivalence to Predicate Device (RadiForce RS240) | Technological characteristics do not affect safety and effectiveness; display characteristics are equivalent. | Confirmed that technological characteristics different from the predicate device do not affect safety and effectiveness. Bench tests demonstrated that display characteristics are equivalent to those of the predicate device and meet pre-defined criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of monitors. The tests were performed "on the RadiForce RX250," implying that these are type tests performed on a representative sample of the device, rather than a statistical sampling of a large population of monitors.
- Data Provenance: This is a physical device (monitor), not an AI algorithm processing medical images. Therefore, "data provenance" in terms of "country of origin of the data" or "retrospective/prospective" is not applicable in the same way it would be for a software device. The tests are bench tests performed on the manufactured device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical display device, and its performance evaluation involves objective physical measurements and conformance to standards (like AAPM TG18), not interpretation by medical experts establishing ground truth for clinical images.
4. Adjudication Method for the Test Set
Not applicable. As this is a physical device undergoing objective bench testing against established technical standards, there is no need for an adjudication method typically used for subjective clinical assessments or AI algorithm outputs.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a medical display monitor itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm. The "standalone" performance here refers to the monitor's characteristics measured directly by test equipment without human visual interpretation as the primary measurement. The listed tests are indeed measurements of the monitor's physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation is established by objective technical standards and guidelines, primarily:
- AAPM Task Group 18 (TG18 guideline): "Assessment of Display Performance for Medical Imaging Systems."
- DICOM GSDF (Grayscale Standard Display Function): A specific tone curve for medical displays.
The device's performance is measured against the specifications and acceptable ranges defined by these standards, not against clinical outcomes or expert consensus on medical images shown on the display.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device (LCD monitor), not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this hardware device.
§ 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).