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This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

RadiForce RX570 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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. There are two model variations, RX570 and RX570-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX570 is Anti-Glare (AG) treatment and that of the RX570-AR is Anti-Reflection (AR) coating. Two RX570 monitors mounted on a single stand configuration is available identified by with "MD" like RX570-MD and RX570-AR-MD. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX570 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 RX570. RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX70 and it's not a medical imaging software.

The provided document describes the EIZO RadiForce RX570; RadiForce RX570-AR medical display monitor and its substantial equivalence to predicate devices, the RadiForce RX560 and RadiForce GX540. It evaluates the device based on performance testing against predefined criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The bench tests below were performed on the RadiForce RX570 following the instructions in 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology' issued on September 28, 2022" and that "the display characteristics of the RadiForce RX570 meet the pre-defined criteria when criteria are set." However, it does not provide a specific table directly listing the acceptance criteria values alongside the measured device performance values.

Instead, it lists the types of measurements performed and provides a general statement about meeting predetermined criteria and equivalence to predicate devices. For example, for DICOM GSDF conformance, it states "Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)," implying that the device met the DICOM GSDF conformance criteria.

Therefore, a table cannot be fully generated with specific numeric acceptance criteria and performance data from the provided text. The document acts as a high-level summary of the testing performed and the conclusion reached.

For a comprehensive table, access to the full test report would be needed. Based on the general statements, the interpretation is that the device did meet the criteria for each test:

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

The document does not explicitly state a "sample size" for the test set in terms of number of devices or datasets. The testing appears to have been performed on the RadiForce RX570 device itself to assess its physical and technical characteristics.

The testing methods are described as "bench tests" performed "following the instructions in 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology'." This indicates the data provenance is from prospective bench testing conducted in a lab environment. There is no information about the country of origin of the data beyond the manufacturer being EIZO Corporation of Japan.

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

This information is not applicable to this submission. The device is a medical display monitor, not an AI or diagnostic software that requires human expert review to establish ground truth for performance evaluation in medical image interpretation. The "ground truth" for this device's performance is established by objective physical measurements based on industry standards and FDA guidance.

4. Adjudication Method for the Test Set

This information is not applicable. Since the performance evaluation relies on objective physical measurements and conformance to technical standards (e.g., DICOM GSDF, TG18 guidelines), there is no need for an adjudication method involving multiple experts.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic AI systems or CADe/CADx devices to evaluate their impact on human reader performance. The RadiForce RX570 is a display monitor, and its performance is evaluated by its technical specifications and adherence to display standards, not by its effect on human readers' diagnostic accuracy.

6. Standalone Performance

A standalone performance evaluation was done. The entire Section 7, "Performance Testing," describes the standalone (algorithm-only, or in this case, device-only) performance testing of the RadiForce RX570. The device's characteristics (e.g., resolution, luminance, DICOM conformance) were measured directly against established technical guidelines and standards.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily based on technical standards, physical measurements, and industry guidelines. Specifically, the document mentions:

• "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology"
• "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)"
• "DICOM GSDF" (Grayscale Standard Display Function)

8. Sample Size for the Training Set

This information is not applicable. The RadiForce RX570 is a physical display device, not an AI algorithm that undergoes training.

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

This information is not applicable for the same reason as above; there is no training set for a display monitor.

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This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

RadiForce RX1270 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 4.200 x 2.800 pixels (12MP) with a pixel pitch of 0.1554 mm. With the matrix size (or resolution) of 4.200 x 2.800 pixels (12MP), the RX1270 is an optimal replacement for traditional dual head 2,048 x 2,560 pixels (5MP) display installations. 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. There are two model variations, RX1270 and RX1270-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX1270 is Anti-Glare (AG) treatment and that of the RX1270-AR is Anti-Reflection (AR) coating. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX1270 based on the OC 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 RX1270.

This document describes the EIZO RadiForce RX1270 and RX1270-AR diagnostic displays. It's a 510(k) submission to the FDA, demonstrating substantial equivalence to a predicate device, the RadiForce RX560. The document focuses on the technical specifications and bench testing of a medical display, not an AI-powered diagnostic device. Therefore, much of the requested information regarding AI study design (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document, as it pertains to AI/CADe systems, not display monitors.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table of acceptance criteria with numerical targets and direct performance outcomes for each criterion. Instead, it lists various bench tests performed and makes a general statement about meeting predetermined criteria and equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. This document describes bench testing of a hardware device (display monitor), not a study involving patient data or images. The "test set" would refer to the physical display units tested.
• Data Provenance: Not applicable in the context of imaging data. The tests were performed according to "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" and AAPM Task Group 18 (TG18 guideline).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in this context, would relate to the accuracy of diagnostic interpretations by a human or AI system. This document concerns the performance characteristics of a display monitor as a tool, not its diagnostic output. Its performance is measured against established physical and photometric standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of medical images, which is not the subject of this document.

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. This document does not mention any MRMC comparative effectiveness study, nor does it discuss AI assistance. The subject is a medical display monitor.

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

No. This document does not describe any algorithm or AI system, standalone or otherwise.

7. The type of ground truth used

For the bench tests, the "ground truth" is established by physical standards and technical specifications for display performance, such as:

• TG18 guideline (AAPM Task Group 18)
• DICOM GSDF (Grayscale Standard Display Function)
• Manufacturer's internal specifications and design targets for parameters like resolution, luminance, contrast ratio, etc.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for it.

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