(62 days)
The RadiForce RX430 is intended to be used in displaying and viewing digital images of X-ray or MRI etc. by trained medical practitioners. The RadiForce RX430 does not support the display of mammography images for diagnosis.
The RadiForce RX430 is a 4MP Color LCD monitor for viewing medical images. The matrix size of the color panel, 2560 x 1600 pixels with a pixel pitch of 0.2505 mm corresponds to two 2MP monitors in portrait mode (1200 x 1600 x 2 with a pixel pitch of e.g. 0.270 mm) and provides dual-head configuration without the obtrusive bezel in the center. 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 RX430 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 RX430.
The provided document describes a 510(k) premarket notification for the EIZO RadiForce RX430, a 4MP Color LCD monitor for displaying medical images. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific performance metrics and acceptance criteria as would be found in a clinical validation study for an AI-powered diagnostic device.
Therefore, many of the requested elements (e.g., specific acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications for ground truth, MRMC study details, standalone performance) are not applicable or not explicitly stated in this type of submission for a medical display monitor.
Here's an attempt to answer the questions based on the available information, highlighting where information is not present in the document.
1. A table of acceptance criteria and the reported device performance
For a medical display monitor, acceptance criteria typically revolve around display characteristics meeting established standards (e.g., DICOM GSDF, luminance, contrast, resolution, viewing angle). The document references these implicitly by comparing the new device to a predicate and stating adherence to standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Display Performance Equivalent to Predicate Device | "RadiForce RX430 can be said to have at least the same display performance as those of the predicate device by default..." |
| Matrix Size / Resolution | RadiForce RX430: 4MP (2560 x 1600 pixels, pixel pitch 0.2505 mm). This "corresponds to two 2MP monitors in portrait mode". The LCD panels used by both the RX430 and predicate device have the same matrix sizes (4096 x 2560) and active area sizes (641.3 mm x 400.8 mm). (Note: There's a discrepancy in stated matrix sizes for RX430 between "4MP (2560 x 1600)" and "4096 x 2560" for the LCD panel. The 4MP (2560x1600) is the effective display resolution for user, while 4096x2560 represents the physical panel resolution. In context, 2560x1600 = 4,096,000 pixels which is roughly 4MP. The 4096x2560 mentioned later is higher resolution, implying the monitor might be downscaling or offering a larger internal resolution than the marketed 4MP. However, for a 510k, comparison to the predicate's panel is key. It is likely referring to manufacturer's panel internal resolution which may be truncated or downscaled to the effective display resolution. Relying on the stated 4MP and direct comparison to predicate for display functionality.) |
| Viewing Angle | RX430 employs In-Plane Switching (IPS) technology, "well-known for its wider viewing angle than other technologies like Twisted Nematic (TN) or Vertical Alignment (VA) employed by the panel of the predicate device." (Implies better or equivalent performance). |
| Luminance Range | "The maximum luminance and the recommended or default luminance of the former [RX430] is much higher" than the predicate device. (Implies better performance). |
| DICOM GSDF Compliance | "The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated display mode stored in one of the lookup tables inside of them." |
| Input Video Signal Compatibility | RX430 supports Digital Visual Interface (DVI) (like predicate) and DisplayPort. "As far as the both the DVI and the DisplayPort are digital, their differences do not affect the image quality." |
| Image Quality / Consistency | "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." "The implementation of the Backlight Sensor (BS) stabilizing the backlight is also the same." "The IFS enables automatic grayscale calibration by measuring the luminance at the screen surface." "The precision data of the calibration with external sensors and with the IFS is provided as one of the validation data." "None of the tests revealed behaviors inconsistent with the expected performance." |
| Safety and EMC Standards Compliance | "The overall design of the RadiForce RX430 was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and in-house ones." |
| No compromise on Safety or Effectiveness compared to predicate | "Any differences between the devices do not affect safety or effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as this is a submission for a display monitor, not an AI or image analysis device that would typically involve patient data test sets. The "validation data" mentioned for IFS precision would refer to technical measurements, not patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable for a display monitor's 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for a display monitor's 510(k) submission.
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
A MRMC study was not done as this is a medical display monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a display monitor, not an algorithm. Its performance is evaluated based on its display characteristics and compliance with technical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the purpose of demonstrating substantial equivalence for a medical monitor, the "ground truth" relates to compliance with technical specifications and standards (e.g., DICOM GSDF, luminance, resolution, safety, EMC). This is established through instrument-based measurements, engineering tests, and adherence to international standards, rather than clinical ground truth like pathology or expert consensus on clinical cases. The document mentions "precision data of the calibration with external sensors and with the IFS" as validation data, which would be an example of instrument-based ground truth.
8. The sample size for the training set
This information is not applicable as the device is a display monitor, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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).