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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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The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not for use for screening or diagnostic mammography.

The RadiForce MX270W is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2560 x 1440 pixels (3.7MP) with a pixel pitch of 0.233 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 MX270W based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce MX270W.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the EIZO RadiForce MX270W monitor.

Note: The provided document is a 510(k) summary for a medical display monitor. As such, the "device" in question is the monitor itself, and the "acceptance criteria" relate to its technical performance for displaying medical images, not a diagnostic AI algorithm. Consequently, many of the requested data points related to AI models (like sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone AI performance) are not applicable to this type of medical device submission.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of an AI algorithm's test set. The "test set" here refers to individual monitors or a representative sample of monitors undergoing a series of bench tests. The document does not specify the number of monitors tested, but it implies standard manufacturing quality assurance and testing procedures.
• Data Provenance: The tests were conducted by the manufacturer, EIZO NANAO Corporation, in Japan, prior to the 510(k) submission. This is retrospective data from internal testing.

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

• Not applicable. This submission is for a display monitor, not an AI diagnostic algorithm. Ground truth, in the context of AI, usually refers to definitive diagnoses by experts or pathology. For a monitor, the "ground truth" and acceptance criteria are based on established technical standards and guidelines (like DICOM GSDF, AAPM TG18, FDA guidance for FFDMM systems) that define acceptable display performance. No individual medical expert "established" ground truth in this context; instead, the criteria are defined by industry and regulatory bodies.

4. Adjudication Method for the Test Set

• Not applicable. Since there's no "ground truth" in the AI sense established by multiple experts requiring adjudication, there is no adjudication method used. The tests are quantitative and objective measurements against predefined technical specifications.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This submission is for a display monitor, which is a tool for viewing images, not an AI algorithm that assists in interpretation.

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

• No, a standalone AI algorithm performance study was not done. This device is a monitor, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Technical Standards and Guidelines: The "ground truth" for evaluating the RadiForce MX270W's performance is adherence to established technical specifications and industry standards for medical displays. These include:
  • DICOM GSDF (Digital Imaging and Communications in Medicine Grayscale Standard Display Function)
  • AAPM Task Group 18 (TG18) guidelines for "Assessment of Display Performance for Medical Imaging Systems"
  • FDA Guidance for Industry and FDA Staff: "Display Accessories for Full-Field Digital Mammography Systems - Premarket Notification (510(k)) Submissions" (specifically for chromaticity measurement).
  • Manufacturer's internal specifications and agreements with LCD panel suppliers for pixel defects.

8. The Sample Size for the Training Set

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

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

• Not applicable. As above, no training set for an AI algorithm is involved.

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