(35 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.
RadiForce RX650 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. With the matrix size (or resolution) of 3,280 x 2,048 pixels (6MP), the RX650 is an optimum replacement for traditional dual head 3MP display installations.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX650 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 RX650.
The provided text describes the EIZO RadiForce RX650, a 6MP Color LCD Monitor intended for displaying and viewing digital medical images (excluding mammography). The document outlines the device's technical specifications, its comparison to a predicate device (RadiForce RX340), and the performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "The test results showed that the RadiForce RX650 has display characteristics equivalent to those of the predicate device, RadiForce RX340. Besides, the display characteristics of the RadiForce RX650 meet the pre-defined criteria when criteria are set."
While the specific numerical acceptance criteria values are not explicitly stated in a table alongside measured performance in this document, the types of tests and the standards they conform to serve as the acceptance criteria. The reported performance is that the device meets these criteria and is equivalent to the predicate device.
| Acceptance Criteria (Test Type / Standard) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF as specified in AAPM Task Group 18 (TG18 guideline) | RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria. |
| Measurement of luminance non-uniformity characteristics (TG18 guideline) | RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria. |
| Measurement of chromaticity non-uniformity characteristics (TG18 guideline) | RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria. |
| Measurement of chromaticity at the center of the display screen at 5%, 50%, and 95% of maximum luminance (FDA Guidance for Full-Field Digital Mammography Systems) | RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria. (Note: The device does not support mammography, but this guidance was used for chromaticity measurements.) |
| Visual check of presence or absence of miscellaneous artifacts on the display screen (TG18 guideline) | RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria. |
| Maximum number allowed for each type of pixel defects/faults | RadiForce RX650 has display characteristics equivalent to the predicate device (RadiForce RX340) and meets predefined criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set. The tests were "bench tests" performed on the RadiForce RX650, which implies laboratory testing of the device itself rather than a study involving patient data. Therefore, the data provenance is the device itself, likely from the manufacturer's testing facilities (EIZO Corporation, Japan). The study is a prospective testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable and not provided. The testing relates to the technical display characteristics of the monitor, not to the interpretation of medical images by human experts. The "ground truth" here is objective physical measurements and adherence to technical standards (like DICOM GSDF, TG18 guidelines).
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in studies where human readers interpret data that needs to be assessed against a consensus ground truth. Here, the tests are objective measurements of the monitor's performance.
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 display monitor, not an AI-powered diagnostic tool. The document states, "No animal or clinical testing was performed on the RadiForce RX650."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable in the context of an AI algorithm as this device is a display monitor. However, the performance tests described are "standalone" in the sense that they evaluate the device itself (the monitor and its associated software like RadiCS) based on objective measurements and compliance with technical standards, without human interpretation of clinical outcomes.
7. The Type of Ground Truth Used:
The ground truth used for these technical performance tests consists of:
- Established Technical Standards: DICOM GSDF (Digital Imaging and Communications in Medicine Grayscale Standard Display Function) and AAPM (American Association of Physicists in Medicine) Task Group 18 (TG18) guidelines.
- FDA Guidance: Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems (used for chromaticity measurements, despite the device not being for mammography).
- Manufacturer Specifications/Internal Criteria: "pre-defined criteria when criteria are set" for aspects like pixel defects/faults.
8. The Sample Size for the Training Set:
This is not applicable and not provided. This device is a hardware display monitor; it does not involve machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set for this 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).