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This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

RadiForce GX550 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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, GX550 and GX550-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX550 is Anti-Glare (AG) treatment and that of the GX550-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 GX550 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 GX550.

The document describes a 510(k) premarket notification for the EIZO RadiForce GX550 and GX550-AR 5MP Monochrome LCD Monitors, intended for displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners, and specially designed for breast tomosynthesis applications.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission refers to "pre-defined criteria" but does not explicitly list them. However, it indicates that the device meets these criteria. The performance testing section outlines the measurements taken, implicitly suggesting these are the aspects against which performance was assessed. Since specific acceptance values are not provided, the table below lists the measured parameters and the statement that the device meets criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document describes bench tests performed on the RadiForce GX550. This indicates a sample size of one device (or a small number of devices directly tested).
• Data Provenance: The tests are prospective bench tests performed on the manufactured device. The location of the testing is not explicitly stated but implies to be conducted by EIZO Corporation, based in Japan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a technical performance verification for a medical display, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here is the established technical specifications and performance standards (e.g., DICOM GSDF, AAPM TG18 guidelines).

4. Adjudication Method for the Test Set

Not applicable. See point 3. Bench tests are objective measurements against technical standards.

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 submission is for a medical display monitor, not an AI-powered diagnostic tool. Therefore, an MRMC study assessing human reader performance with or without AI assistance is not relevant and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a medical display, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on established technical standards and guidelines for medical displays. Specifically, the document mentions:

• DICOM GSDF (Grayscale Standard Display Function): A standardized luminance response curve for medical images.
• AAPM Task Group 18 (TG18) guideline: "Assessment of Display Performance for Medical Imaging Systems," which provides methodologies and criteria for evaluating medical display monitors.

8. The Sample Size for the Training Set

Not applicable. This device is a display monitor, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

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