(17 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 RX660 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 and the matrix size (or resolution) is 3,280 x 2,048 pixels (6MP) with a pixel pitch of 0.1968 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.
There are two model variations, RX660 and RX660-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX660 is Anti-Glare (AG) treatment and that of the RX660-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX660 based on the QC 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 RX660.
The provided document describes the FDA 510(k) premarket notification for the EIZO RadiForce RX660 and RX660-AR 6MP Color LCD Monitors. This document focuses on demonstrating substantial equivalence to a predicate device (RadiForce RX650) rather than proving the device meets clinical acceptance criteria via a clinical study with a ground truth established by experts.
The acceptance criteria and performance reported are for technical characteristics of the monitor, not for a software algorithm's diagnostic performance. Therefore, many of the requested categories related to clinical studies, expert ground truth, and human reader performance are not applicable or cannot be extracted from this document.
Here's an analysis based on the information provided:
Acceptance Criteria and Reported Device Performance
The document states that the display characteristics of the RadiForce RX660 "meet the pre-defined criteria when criteria are set." It also claims that the test results showed that the RadiForce RX660 has display characteristics equivalent to those of the predicate device. RadiForce RX650.
While specific numerical acceptance criteria for each test (e.g., maximum allowable deviation for DICOM GSDF conformance, or specific MTF values) are not fully detailed in the provided text, the criteria revolve around meeting established display performance standards and demonstrating equivalence to the predicate device.
Table 1: Acceptance Criteria and Reported Device Performance (Summary derived from section 9, not exhaustive of all potential pre-defined criteria)
| Acceptance Criterion (Implicit/Derived) | Reported Device Performance (RadiForce RX660) |
|---|---|
| Conformance to DICOM GSDF (as per AAPM TG18 guideline) | Conforms to DICOM GSDF |
| Luminance non-uniformity characteristics (as per AAPM TG18 guideline) | Measured, characteristics equivalent to predicate |
| Chromaticity non-uniformity characteristics (as per AAPM TG18 guideline) | Measured, characteristics equivalent to predicate |
| Chromaticity at center (5%, 50%, 95% max luminance) | Measured, characteristics equivalent to predicate |
| Presence/absence of miscellaneous artifacts (as per AAPM TG18 guideline) | Visually checked, characteristics equivalent to predicate |
| Spatial resolution (MTF) | Measured, characteristics equivalent to predicate |
| Maximum number of pixel defects/faults | Conforms to maximum allowed number |
| Overall Display Characteristics | Meet pre-defined criteria and are equivalent to those of the predicate device (RadiForce RX650). |
Study Information (Based on provided text)
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Sample size used for the test set and the data provenance: Not applicable. This document describes technical bench testing of monitor hardware, not a study involving medical images or patient data. The "test set" refers to the monitors themselves.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" using human experts was established, as this was a technical performance evaluation of a display device, not a diagnostic algorithm.
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Adjudication method for the test set: Not applicable. No expert adjudication process was involved.
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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 algorithm. No MRMC study was performed or described.
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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.
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The type of ground truth used: Not applicable. The "ground truth" for the technical tests would be the established physical and electrical standards for monitor performance (e.g., DICOM GSDF standard, objective measurements from calibrated instruments).
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The sample size for the training set: Not applicable. This is a hardware device (monitor); there is no "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable. No training set or associated ground truth.
In summary: The provided document is an FDA 510(k) submission for a medical display monitor. It focuses on demonstrating that the new device's technical specifications and performance are substantially equivalent to a previously cleared predicate device. The "acceptance criteria" and "study" described are technical bench tests of the monitor's display characteristics against established industry guidelines (like AAPM TG18) and comparison to the predicate, not clinical performance studies involving patient data or human expert interpretation.
§ 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).