(71 days)
The RadiForce GX340 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 is not specified for digital mammography system.
The RadiForce GX340 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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 "GX340" such as "GX340-CL", a model whose backlight is Clear Base (one of tints) .
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX340 based on several OC guidelines. The RadiCS and its subset. RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX340.
Acceptance Criteria and Study for EIZO RadiForce GX340 Monitor
This document describes the acceptance criteria and the study conducted for the EIZO RadiForce GX340 3MP Monochrome LCD Monitor. The information is based on the provided Traditional 510(k) Summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device (RadiForce GS320) by showing that the new device meets or exceeds the predicate's performance in key areas and that any differences do not affect safety or effectiveness. The performance is largely framed as either "same as" or "higher than" the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance and Comparison to Predicate (RadiForce GS320) |
|---|---|
| Resolution/Matrix Size (Equivalence to predicate) | Same: 1,536 x 2,048 pixels (3MP) |
| Active Area Size (Equivalence to predicate) | Same: 324.8 mm x 433.1 mm |
| DICOM Calibrated Luminance (Equivalence or improvement) | Higher: 500 cd/m² (vs. 450 cd/m² for predicate) |
| Typical Maximum Luminance (Equivalence or improvement) | Higher: 1200 cd/m² (vs. 1000 cd/m² for predicate) |
| Tone Curve (DICOM GSDF compliance) (Equivalence) | Both devices display images in accordance with DICOM GSDF by default, utilizing factory calibrated display modes stored in lookup tables. |
| Backlight Type and Performance (No adverse effects on quality) | LED backlight employed (vs. CCFL for predicate). Stated: "We have not recognized any adverse effects of the LED backlight on the quality of displayed images." Deteriorates more slowly. |
| Input Video Signal Compatibility (Equivalence/improvement) | Supports DVI (same as predicate) and DisplayPort (new). Stated: "As far as the both the DVI and the DisplayPort are digital, their differences do not affect the quality of displayed images." |
| Maintenance/QC Software (Equipvalency) | Same QC software (RadiCS/RadiCS LE) is used for both devices. |
| Backlight Stabilization (Equivalence) | Implementation of Backlight Sensor (BS) for stabilizing backlight is the same. |
| Grayscale Calibration Accuracy (with IFS vs. external sensor) | "Accuracy data of the calibration with external sensors and that with the IFS is included in section 16.9 'Verification and Validation Documentation'." (Specific values not provided in summary) |
| Safety and EMC Standards Compliance | Overall design validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and in-house ones. |
| Overall Performance (No unpredicted behaviors) | "EIZO NANAO CORPORATION performed a range of system and performance tests to ensure that the RadiForce GX340 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an algorithmic assessment with a specific sample size of medical images. The evaluation is focused on the device's physical and technical characteristics as a display monitor.
The "study" described is a bench testing and technical comparison against a predicate device. There is no indication of clinical image data being used as a "test set" in the typical AI/CAD sense.
Data provenance is not applicable as the evaluation is primarily hardware-focused, comparing the new monitor's specifications and performance to a previous model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. This submission is for a medical display monitor, not an AI/CAD algorithm that requires expert-established ground truth on medical images. The "ground truth" here relates to engineering specifications and performance standards (e.g., luminance, resolution, DICOM compliance).
4. Adjudication Method for the Test Set
Not applicable. As stated above, this is a hardware device submission, not an AI/CAD algorithm requiring image-based adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not conducted as this is a medical display monitor, not an AI/CAD system designed to assist human readers. The context is ensuring the display device itself is equivalent to or better than its predicate in showing images accurately.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a display monitor. While it has embedded firmware and calibration features (like the Built-in Front Sensor for automatic grayscale calibration), it is not an "algorithm" in the sense of an independent diagnostic or assistive software. Its performance is evaluated on its ability to accurately render images, not to interpret them autonomously.
7. Type of Ground Truth Used
The "ground truth" used in this submission is primarily based on:
- Engineering specifications and measurements: The device's luminance, resolution, pixel pitch, active area, and tone curve adherence to DICOM GSDF are objectively measured and compared.
- Industry standards: Compliance with DICOM GSDF, international safety, and EMC standards.
- Comparison to predicate device's established performance: The predicate (RadiForce GS320) serves as a benchmark for acceptable performance.
8. Sample Size for the Training Set
Not applicable. Since this is a hardware device (display monitor) and not an AI/CAD algorithm, there is no "training set" in the context of machine learning. The monitor is designed and manufactured to meet specific engineering specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/CAD algorithm, there is no ground truth established for it in this context. The manufacturing and testing processes ensure the monitor meets its stated specifications and complies with relevant standards.
§ 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).