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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 RS240 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 1,200 x 1,600 pixels (2MP).

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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RS240 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 RS240.

The provided text describes the 510(k) summary for the EIZO RadiForce RS240 monitor, which is a display device for medical images. It's important to note that this document is for a medical monitor, not an AI-powered diagnostic device or software. Therefore, many of the requested criteria related to AI performance, ground truth, and human reader studies are not applicable to this submission.

Based on the provided text, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set. |
| Measurement of luminance non-uniformity characteristics (as specified in TG18 guideline) | The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance.

The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set. |
| Measurement of chromaticity non-uniformity characteristics (as specified in TG18 guideline) | The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance.

The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set. |
| Measurement of chromaticity at center of display at 5%, 50%, and 95% of maximum luminance (as specified in FDA Guidance for FM) | The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance.

The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set. |
| Visual check of presence or absence of miscellaneous artifacts (as specified in TG18 guideline) | The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance.

The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set. |
| Measurement of spatial resolution (expressed as Modulation Transfer Function - MTF) | The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance.

The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set. |
| Maximum number allowed for pixel defects/faults | The test results showed that the RadiForce RS240 has display characteristics equivalent to those of the predicate device, RadiForce RX240, except for some items, each of which was determined not to affect observer's performance.

The display characteristics of the RadiForce RS240 meet the pre-defined criteria when criteria are set. |

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of patient data or images. The testing described refers to bench tests of the monitor's performance characteristics. Therefore, there's no sample size of images or data provenance in the way one would describe for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The testing was for the technical performance of a display device, not for diagnostic accuracy evaluated against a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.

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
Not applicable. This is a medical display device, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical display device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a medical display device would be the established technical standards (e.g., DICOM GSDF, TG18 guidelines) against which its performance is measured, not clinical diagnostic ground truth.

8. The sample size for the training set
Not applicable. There is no AI model or training set involved for a medical display device.

9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved for a medical display device.

Summary of Device and Study Type:

The EIZO RadiForce RS240 is a 2MP Color LCD Monitor intended for displaying digital medical images for review, analysis, and diagnosis by trained medical practitioners (excluding mammography images). The study conducted was a series of bench tests to verify the monitor's technical specifications and conformance to industry standards (like AAPM TG18 guideline and FDA guidance for display accessories). The primary goal was to demonstrate substantial equivalence to a predicate device (RadiForce RX240) by showing that any technological differences do not affect safety or effectiveness, and that its display characteristics meet pre-defined criteria. There was no animal or clinical testing performed.

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