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This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

RadiForce MX242W 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 with the matrix size (or resolution) of 1,920 x 1,200 pixels (2.3MP).

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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX242W 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 MX242W.

This document is a 510(k) premarket notification for a medical display, the EIZO RadiForce MX242W. As such, it describes performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria related to clinical diagnostic accuracy or reader performance. The "acceptance criteria" here refer to technical display performance specifications.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the tests performed and the comparison to the predicate device. The document explicitly states that "The test results showed that the RadiForce MX242W has display characteristics equivalent to those of the predicate device, RadiForce MX270W," and "Besides, the display characteristics of the RadiForce MX242W meet the pre-defined criteria when criteria are set."

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

The "test set" in this context refers to bench testing of the device itself, not a dataset of medical images.

• Sample Size: This information is not explicitly provided for the bench tests. It likely refers to testing of a single or a small number of production units.
• Data Provenance: The tests were performed in the manufacturer's facility, likely in Japan (country of origin for EIZO Corporation). This was prospective testing on the manufactured device.

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

Not applicable. This is not a study involving human interpretation of medical images or establishment of medical ground truth. The "ground truth" for the bench tests is based on established technical standards and guidelines (e.g., DICOM GSDF, AAPM TG18).

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or adjudication involved in the technical bench tests; rather, physical measurements and comparisons to defined technical standards are performed.

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 MRMC comparative effectiveness study was done. This device is a display monitor, not an AI diagnostic algorithm. The aim was to show substantial equivalence to a predicate display, not to evaluate human reader performance with or without AI. The document explicitly states: "No animal or clinical testing was performed on the RadiForce MX242W."

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

Not applicable. This is a medical display, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the display's performance evaluation refers to established technical specifications and performance criteria from industry standards and regulatory guidance documents, such as:

• AAPM Task Group 18 (TG18 guideline)
• Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
• DICOM GSDF (Grayscale Standard Display Function)

8. The sample size for the training set

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

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary of the Study (Bench Testing):

The study was a series of bench tests conducted on the EIZO RadiForce MX242W monitor. The purpose was to demonstrate substantial equivalence to a legally marketed predicate device (RadiForce MX270W) as required for a 510(k) submission. The tests evaluated technical display characteristics against established industry guidelines and standards to ensure the new device performs acceptably for its intended use, which is displaying medical images for review and analysis by trained practitioners (excluding mammography). Although there were some differences in resolution, aspect ratio, and physical size compared to the predicate, these differences were argued not to affect the safety and effectiveness of the device.

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