(21 days)
RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.
RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 displays high-definition medical imaging.
The provided text describes a 510(k) summary for the EIZO NANAO CORPORATION's Color LCD Monitor, RadiForce RX320. This document primarily focuses on establishing substantial equivalence to a predicate device (RadiForce R31 and R31-C) rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of a clinical trial for an AI/CAD product.
The device is a medical display monitor, and its "performance" is evaluated based on its technical specifications compared to the predicate device. The acceptance criteria essentially revolve around demonstrating that the new device meets or exceeds the specifications of the predicate device, or that any differences do not raise new questions of safety and effectiveness.
Here's a breakdown based on your request, with the understanding that the nature of the device (a monitor) means "performance" and "ground truth" are interpreted differently than for an AI diagnostic algorithm:
- A table of acceptance criteria and the reported device performance:
| Feature/Acceptance Criteria (Predicate R31/R31-C) | Reported Device Performance (RX320) | Meets/Exceeds |
|---|---|---|
| Brightness: 400 cd/m² | 900 cd/m² | Exceeds |
| Contrast Ratio: 400:1 (typical) | 1000:1 (typical) | Exceeds |
| Response Time: 50 ms (typical) | 20 ms (typical) | Exceeds |
| Panel Size: 53 cm (20.8") TFT Color LCD | 54cm (21.2") TFT Color LCD | Exceeds (slightly larger) |
| Pixel Pitch: 0.207 x 0.207mm | 0.21075 x 0.21075 mm | Similar (slightly larger pixel) |
| Scanning Frequency (H, V): 31-127kHz, 59-61Hz | 31-127kHz, 29-61Hz | Similar |
| Native Resolutions: 2048 x 1536 (portrait) | Same as R31 and R31-C | Meets |
| Display Colors: 10-bit: 1.06 billion (max) | Same as R31 and R31-C | Meets |
| Viewing Angles: H: 170°, V: 170° | Same as R31 and R31-C | Meets |
| Luminance Calibration: Software (Optional), Photo-sensor (Optional) | Software (Optional), Photo-sensor (Optional), Digital Uniformity Equalizer (DUE) | Exceeds (added DUE) |
| Intended Use: Display and view digital images for diagnosis of X-ray or MRI etc. (excluding mammography) | Same as predicate | Meets |
Note: The acceptance criteria here are implicitly defined by the specifications of the predicate device. The new device demonstrates "substantial equivalence" by meeting or improving upon these key specifications.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This is not applicable to a medical display monitor's 510(k) submission. The "test set" would be the device itself being tested for its physical and electrical characteristics, not a set of medical images. The document does not describe a study involving medical image data.
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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):
- Not applicable as no "ground truth" for medical image interpretation is established for this device submission. The device is a display, not a diagnostic algorithm.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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:
- Not applicable. This device is a display monitor, not an AI/CAD system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (monitor), not an algorithm. Its "standalone performance" refers to its technical specifications (brightness, contrast, etc.) as listed in the table, which are inherently "algorithm-only" in the sense that they are physical measurements of the device's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for a monitor is its adherence to technical manufacturing specifications and industry standards for display performance (e.g., luminance, contrast, resolution), measured using calibrated equipment. This document does not detail the specific test methods or "ground truth" sources used to verify these specifications, but it is implied to be standard engineering and quality control procedures.
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The sample size for the training set:
- Not applicable. This device does not involve machine learning algorithms.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved 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).