(28 days)
This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
The RadiForce RX440 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2,560 x 1,600 pixels (4MP) with a pixel pitch of 0.2505 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 "RX440" such as "RX440-AR", a model 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 RX440 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 RX440.
Here's a breakdown of the acceptance criteria and study information for the Eizo RadiForce RX440 monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance for RadiForce RX440 |
|---|---|
| Conformance to DICOM GSDF (as specified in AAPM TG18 guideline) | Verification performed. No behaviors inconsistent with expected performance. |
| Luminance non-uniformity characteristics (as specified in TG18 guideline) | Measurement performed. No behaviors inconsistent with expected performance. |
| Chromaticity non-uniformity characteristics (as specified in TG18 guideline) | Measurement performed. No behaviors inconsistent with expected performance. |
| Chromaticity at center of display screen at 5%, 50%, and 95% of maximum luminance (as specified in FDA Guidance for Display Accessories for Full-Field Digital Mammography Systems) | Measurement performed. No behaviors inconsistent with expected performance. |
| Presence or absence of miscellaneous artifacts (as specified in TG18 guideline) | Visual check performed. No behaviors inconsistent with expected performance. |
| Maximum allowed pixel defects/faults | The maximum number agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce RX440. No mention of exceeding this. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing performed on the RadiForce RX440. It does not specify a "test set" in terms of patient data or images. The testing was conducted on the device itself.
- Sample Size for Test Set: Implicitly, the physical device(s) of the RadiForce RX440 model. Not specified as a quantity, but suggests testing was performed on at least one unit.
- Data Provenance: The testing was performed by Eizo Nanao Corporation (Japan) on their own manufactured device. This is a prospective evaluation of the manufactured device's physical characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is not applicable to the described performance testing. The "ground truth" for these tests are objective technical specifications and measurement standards (e.g., DICOM GSDF, TG18 guideline specifications, FDA guidance). Expert consensus is not relevant for verifying these physical and performance aspects of a display monitor.
4. Adjudication Method for the Test Set
This is not applicable as there was no 'test set' of expert-reviewed data. The performance was assessed against objective technical standards and guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is outside the scope of testing a medical display monitor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm-only) performance test was not done. This device is a display monitor, not an algorithm. Its performance is evaluated independently of human interpretation of displayed images, but it relies on a human user for its intended purpose.
7. The Type of Ground Truth Used
The ground truth used for these tests was objective technical specifications and industry standards/guidelines. These include:
- DICOM GSDF (Grayscale Standard Display Function)
- AAPM Task Group 18 (TG18 guideline) for Assessment of Display Performance for Medical Imaging Systems
- FDA Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
- Manufacturer's internal specifications for pixel defects/faults.
8. The Sample Size for the Training Set
This is not applicable. The RadiForce RX440 is a display monitor, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as 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).