(46 days)
The RadiForce RX840 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
The RadiForce RX840 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 4096 x 2160 pixels (8MP), spacious enough to display e.g. two 3MP radiological images and other clinical information side by side without obtrusive bezels.
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 "RX840" such as "RX840-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 RX840 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840.
The provided text describes a 510(k) submission for the EIZO RadiForce RX840 8MP Color LCD Monitor. It does not contain information about a study with acceptance criteria for a device that uses AI or a human-in-the-loop component. Instead, it focuses on demonstrating substantial equivalence of the RX840 monitor to a predicate device (FlexScan MX300W) based on technological characteristics and performance benchmarks.
Therefore, many of the requested sections about AI-specific criteria, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this document. The document describes a display monitor, not an AI diagnostic tool.
Here's a breakdown of the information that is present or can be inferred, along with explanations for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit acceptance criteria in the typical sense for a diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, it focuses on demonstrating that the proposed device (RadiForce RX840) meets or exceeds the performance characteristics of its predicate device, the FlexScan MX300W. The "acceptance criteria" here are implicitly tied to the performance of the predicate device.
| Characteristic | Predicate Device (FlexScan MX300W) Performance | Proposed Device (RadiForce RX840) Performance | Acceptance/Comparison Metric |
|---|---|---|---|
| Matrix Size (Resolution) | 2,560 x 1,600 | 4,096 x 2,160 (8MP) | Larger than predicate |
| Active Area Size | 641.3 mm x 400.8 mm | 817.1 mm x 430.9 mm | Larger than predicate |
| Pixel Pitch/Size | 0.2505 x 0.2505 mm | 0.1995 x 0.1995 mm | Smaller (higher density) than predicate |
| DICOM Calibrated Luminance | 170 cd/m² | 400 cd/m² | Higher than predicate |
| Typical Maximum Luminance | 300 cd/m² | 700 cd/m² | Higher than predicate |
| Backlight Type | CCFL | LED | Newer, mercury-free, less power, slower deterioration |
| DICOM GSDF Compliance | Yes (via factory calibrated display modes) | Yes (via factory calibrated display modes) | Same as predicate |
| Input Video Signal | DVI | DVI, DisplayPort | Improved/additional options |
| QC Software | Uses same QC software (RadiCS/RadiCS LE) | Uses same QC software (RadiCS/RadiCS LE) | Same as predicate |
| Backlight Sensor (BS) | Present | Present | Same as predicate |
| Built-in Front Sensor (IFS) | Not explicitly mentioned | Present (for automatic grayscale calibration) | Improved (reduces human intervention) |
| Safety & EMC Standards | Not detailed for predicate | Validated (internationally recognized) | Meets standards |
| Image Quality Characteristics | Not detailed, but section 18 references comparison with predicate | Not detailed, but section 18 references comparison with predicate | "several image quality characteristics... compared" |
The document states: "The RadiForce RX840 can be said to have at least the same display performances as those of the predicate device by default..." and "The specifications of the primary component employed by the proposed device are superior to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness." This indicates that the "acceptance criteria" were met by demonstrating equivalence or superiority to the predicate device's established performance without introducing adverse effects.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving patient data or a test set in the context of an AI algorithm. The performance evaluation is based on device specifications and benchmark testing of the monitor hardware and software.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. There is no "ground truth" establishment in the context of diagnostic interpretation for this monitor's submission. The "ground truth" for monitor performance would be established by objective measurements and adherence to technical standards.
4. Adjudication Method for the Test Set
Not applicable. No diagnostic test set or adjudication process is described.
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. This document describes a monitor, not an AI system. Therefore, an MRMC comparative effectiveness study regarding AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a display monitor, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is typically established by:
- Engineering specifications and objective measurements: Calibrated luminance, resolution, pixel pitch, tone curve adherence (DICOM GSDF), color accuracy, etc.
- Adherence to recognized standards: Safety (e.g., IEC 60601-1) and EMC standards.
- Comparison to predicate device performance: Demonstrating that the new device's performance characteristics are equivalent or superior without raising new safety or effectiveness concerns.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a training set as it is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).