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This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

RadiForce GX560 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, GX560 and GX560-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX560 is Anti-Glare (AG) treatment and that of the GX560-AR is Anti-Reflection (AR) coating.

Two GX560 monitors mounted on a single stand configuration is available identified by with "MD" like GX560-MD and GX560-AR-MD.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX560 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 GX560.

The provided document is a 510(k) summary for the EIZO RadiForce GX560 and GX560-AR medical display monitors. It describes the device, its intended use, comparison to a predicate device, and performance testing. However, the document does not contain information about a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, multi-reader multi-case studies, or AI assistance.

The "Performance Testing" section (page 7) describes bench tests performed on the RadiForce GX560, specifically to evaluate display characteristics. These tests are about the technical performance of the monitor itself (e.g., spatial resolution, luminance, temporal response, adherence to DICOM GSDF), not the diagnostic performance of a human reader using the display, nor are they related to AI assistance.

Therefore, I cannot fulfill your request for the following sections, as the information is not present in the provided text:

• 1. A table of acceptance criteria and the reported device performance (in the context of clinical/diagnostic performance with human readers or AI). The document only gives technical acceptance criteria for the display's physical properties.
• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective). No clinical test set involving patient data is mentioned.
• 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). No expert review or ground truth establishment is mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set. Not applicable.
• 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. The document explicitly states: "No animal or clinical testing was performed on the RadiForce GX560." This means no human reader studies, MRMC studies, or AI assistance studies were conducted or reported in this 510(k) summary.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. This device is a display monitor, not an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc). Not applicable.
• 8. The sample size for the training set. Not applicable, as this is not an AI/algorithm device.
• 9. How the ground truth for the training set was established. Not applicable.

Summary of available information regarding acceptance criteria and performance (bench testing):

The document focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce GX550) based on technological characteristics and bench performance tests of the display itself.

Acceptance Criteria for the Display Device (as extracted from "7. Performance Testing"):

The general acceptance criteria for the RadiForce GX560 are stated as:

• "The test results showed that the RadiForce GX560 has display characteristics equivalent to those of the predicate device, RadiForce GX550."
• "Besides, the display characteristics of the RadiForce GX560 meet the pre-defined criteria when criteria are set." (Specific quantitative criteria are not detailed in this summary document, but typically refer to standards like TG18.)

Reported Device Performance (from "7. Performance Testing"):

The document states that the following bench tests were performed, and the results showed equivalence to the predicate device and met pre-defined criteria:

• Measurement of spatial resolution expressed as modulation transfer function (MTF)
• The maximum number allowed for each type of pixel defects/faults
• Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
• Measurement of temporal response
• Measurement of Luminance
• Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
• Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
• Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline
• Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
• Performance data on luminance stability
• Measurement of noise expressed as noise power spectrum (NPS)
• Measurement of display reflections including specular, diffuse and haze components
• Measurement of small-spot contrast ratio
• Measurement of pixel aperture ratio

In conclusion, this 510(k) summary for a medical display monitor does not describe any studies related to human diagnostic performance, AI assistance, or the clinical effectiveness of the device in a diagnostic workflow. It solely focuses on the technical characteristics and performance of the display hardware to demonstrate substantial equivalence for its intended use in displaying radiological images.

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