(21 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 RS340 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 1.536 x 2.048 pixels (3MP).
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.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RS340 based on the OC 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 RS340.
This document describes the EIZO Corporation 3MP Color LCD Monitor, RadiForce RS340, a device intended for displaying digital images for review, analysis, and diagnosis by trained medical practitioners (excluding mammography images).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the RadiForce RS340 meets "pre-defined criteria when criteria are set" and that its display characteristics are "equivalent to those of the predicate device, RadiForce RX340 except one item, which was determined that it would not affect observer's performance." Specific numerical acceptance criteria are not explicitly detailed in the provided text. However, the performance tests conducted indicate the following areas of evaluation and implied criteria based on conformance to industry guidelines:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF (AAPM TG18 guideline) | Verified conformance to DICOM GSDF. |
| Luminance non-uniformity characteristics (AAPM TG18 guideline) | Measurement performed; results show equivalence to predicate except for one item not affecting observer performance. |
| Chromaticity non-uniformity characteristics (AAPM TG18 guideline) | Measurement performed; results show equivalence to predicate except for one item not affecting observer performance. |
| Chromaticity at center (5%, 50%, 95% max luminance) (FDA Guidance for Mammography Display Accessories) | Measurement performed; results show equivalence to predicate except for one item not affecting observer performance. |
| Absence of miscellaneous artifacts (AAPM TG18 guideline) | Visual check performed; results show equivalence to predicate except for one item not affecting observer performance. |
| Spatial resolution (MTF) | Measurement performed; results show equivalence to predicate except for one item not affecting observer performance. |
| Maximum allowed pixel defects/faults | Test performed; results show equivalence to predicate except for one item not affecting observer performance. |
| Equivalence to Predicate Device (RadiForce RX340) | The RadiForce RS340 has display characteristics equivalent to those of the predicate device, RadiForce RX340, with one exception that was determined not to affect observer's performance. The device also meets "pre-defined criteria when criteria are set." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of image data or patient studies. The performance testing described refers to bench tests performed on the RadiForce RS340 monitor itself. Therefore, there is no mention of sample size for a test set of data or its provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, the testing was focused on the monitor's technical performance characteristics, not on diagnostic accuracy based on medical images. Therefore, no ground truth established by medical experts for a test set was required or mentioned.
4. Adjudication method for the test set
Not applicable, for the same reasons as point 3.
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. The device is a medical display monitor, not an AI diagnostic algorithm. The testing described is for the display's technical performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a medical display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing of the display monitor was based on established industry standards and guidelines, specifically:
- AAPM Task Group 18 (TG18 guideline): For DICOM GSDF conformance, luminance non-uniformity, chromaticity non-uniformity, and visual checks for artifacts.
- Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions: For chromaticity at the center of the display screen.
These guidelines define acceptable technical performance parameters for medical displays.
8. The sample size for the training set
Not applicable. This device is a display monitor, not a machine learning model; therefore, no training set was used.
9. How the ground truth for the training set was established
Not applicable. As there was no training set, no ground truth for a training set was established.
§ 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).