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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 RX350 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 1,536 x 2,048 pixels (3MP).

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 "RX350" such as "RX350-AR", a model with an Anti-Reflective coating although the hardware design, components and labeling remain unchanged.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX350 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 RX350.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria from an AI performance perspective. The document is a 510(k) premarket notification for a medical display monitor (EIZO RadiForce RX350), not an AI/ML medical device.

The "Performance Testing" section describes bench tests performed on the display monitor to verify its performance characteristics (e.g., DICOM GSDF conformance, luminance, chromaticity, spatial resolution, pixel defects). The conclusion states that "The test results showed that the RadiForce RX350 has display characteristics equivalent to those of the predicate device... Besides, the display characteristics of the RadiForce RX350 meet the pre-defined criteria when criteria are set." However, it does not provide the specific "pre-defined criteria" in a table format with reported device performance, nor does it involve AI/ML performance metrics.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria for an AI device.

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