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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 MX215 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 MX215 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 MX215.

The document describes the performance testing conducted for the EIZO RadiForce MX215 2MP Color LCD Monitor to demonstrate its substantial equivalence to the predicate device, RadiForce RS210.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete "acceptance criteria" table with specific pass/fail thresholds alongside reported device performance for each criterion. Instead, it states that "the RadiForce MX215 has display characteristics equivalent to those of the predicate device, RadiForce RS210" and "meet the pre-defined criteria when criteria are set." The performance tests were primarily conducted based on established guidelines to ensure the device performs at least as well as the predicate and adheres to medical display standards.

However, based on the descriptions, we can infer the tested characteristics and the general performance goal:

2. Sample Size and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the test set. It refers to "the RadiForce MX215" (singular), implying that the testing was performed on at least one unit of the device. Given the nature of monitor testing, it's common to test a representative sample rather than a large cohort.
• Data Provenance: The document does not provide details about the country of origin of the data or whether the study was retrospective or prospective. It describes "bench tests" performed by EIZO Corporation.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This study involved "bench tests" to evaluate the hardware performance of a display monitor, not a diagnostic algorithm that relies on expert interpretation for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as this was a bench testing study for a display monitor's technical specifications, not an assessment requiring human interpretation and consensus for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is typically conducted for AI algorithms or diagnostic tools where the performance of human readers with and without AI assistance is being compared. This document describes the technical performance evaluation of a medical display monitor.
• Effect Size of Human Reader Improvement: Not applicable.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Not applicable. The device is a display monitor, not an algorithm. The testing described is for the monitor's physical and display characteristics.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this study was based on pre-defined technical criteria and standards from recognized guidelines such as AAPM TG18 and FDA Staff Guidance for Display Accessories for Full-Field Digital Mammography Systems. It involved objective measurements of display characteristics (e.g., luminance, chromaticity, uniformity) and visual checks against established specifications, rather than clinical outcomes, pathology, or expert consensus on medical images.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The RadiForce MX215 is a hardware device (a monitor), not a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for a hardware device like a medical display monitor.

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