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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce MX243W 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 1,920 x 1,200 pixels (2.3MP) with a pixel pitch of 0.270 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX243W 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 MX243W.

RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX243W and it's not a medical imaging software.

The provided document is a 510(k) summary for the EIZO RadiForce MX243W medical display. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance testing of the display itself, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies (sample size for test/training set, data provenance, number/qualifications of experts, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable to this submission.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the RadiForce MX243W's display characteristics meet "pre-defined criteria when criteria are set" and are "equivalent to those of the predicate device, RadiForce MX242W." However, it does not provide a specific table detailing the numerical acceptance criteria for each test and the corresponding reported performance values. It only lists the types of tests performed.

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

This is not applicable as the submission is for a medical display, not an AI/ML device that operates on patient data. The tests were performed on the physical display unit.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert labels on medical images) does not apply to the performance testing of a monitor. The tests performed are objective measurements based on established guidelines.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the purpose of this submission (a medical display).

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

No, a standalone performance study was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for display performance testing refers to objective physical standards and measurements rather than expert consensus on medical findings. The tests performed are based on guidelines such as the AAPM TG18 guideline and "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The manufacturer performed bench tests on the RadiForce MX243W medical display. These tests were conducted following the instructions in the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and referenced the AAPM Task Group 18 (TG18) guideline for assessment of display performance.

The specific tests performed include:

• Measurement of spatial resolution (Modulation Transfer Function - MTF)
• Evaluation of pixel defects/faults
• Visual check for miscellaneous artifacts on the display screen (as specified in TG18)
• Measurement of temporal response
• Measurement of Luminance
• Verification of conformance to DICOM GSDF (as specified in TG18)
• Measurement of pixel aperture ratio
• Measurement of Color tracking

The document states that the "test results showed that the RadiForce MX243W has display characteristics equivalent to those of the predicate device, RadiForce MX242W" and that "the display characteristics of the RadiForce MX243W meet the pre-defined criteria when criteria are set."

No animal or clinical testing was performed for this device. The conclusion is that the device is substantially equivalent to its predicate based on its intended use, that technological differences do not affect safety or effectiveness, and that the bench tests demonstrated equivalent display characteristics.

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