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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 GX570 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome 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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

The Digital Uniformity Equalizer function compensates luminance non-uniformity, one of the inherent characteristics of LCD panel modules, to the levels required by various QC standards and guidelines.

The Sharpness Recovery function compensates sharpness degradation caused by the inherent characteristics of LCD panel modules (A user selectable).

There are two model variations, GX570 and GX570-AR. The difference of the two variations is the surface treatment of the GX570 is Anti-Glare (AG) treatment and that of the GX570-AR is Anti-Reflection (AR) coating.

Two GX570 monitors mounted on a single stand configuration is available identified by with "MD" like GX570-MD and GX570-AR-MD.

RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce GX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX570.

RadiCS is of Basic Documentation Level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce GX570 and it's not a medical imaging software.

The provided FDA 510(k) clearance letter and summary are for a medical display monitor (RadiForce GX570), not an AI device or a diagnostic algorithm. Therefore, the information requested regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.

The document discusses the technical performance of a display monitor, such as:

• Spatial resolution (MTF)
• Pixel defects
• Luminance and chromaticity (including DICOM GSDF conformance)
• Temporal response
• Noise (NPS)
• Display reflections
• Small-spot contrast ratio

These are physical and optical performance characteristics of a display hardware, not the diagnostic performance of a software algorithm.

Therefore, I cannot populate the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment, as this information is not relevant to a medical display monitor clearance.

The document does state that the device is intended for use with "clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners." However, the studies described are bench tests to assure the display hardware meets performance standards for displaying these images, not for interpreting them with AI.

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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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5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis

MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor. Their displays' resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

Here's a breakdown of the acceptance criteria and study information for the JVC Kenwood medical monitors, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the JVC KENWOOD monitors (MS55i2 and CCL550i2) primarily focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce GX540) rather than presenting specific, quantitative acceptance criteria and results. The "acceptance criteria" can be inferred as matching or being equivalent to the key performance specifications of the predicate device, especially those related to image quality and functionality for diagnostic medical imaging.

Explanation of Differences and Performance Justification:

• Grayscale Tones: While the palette size for grayscale tones differs, the document states, "But our monitors pass the exams in AAPM-TG18 4.3 'Luminance Response'. Our monitors are equivalent to the predicated device." This indicates that despite the numerical difference in palette size, the devices meet the relevant image quality standards for grayscale reproduction.
• Non-Uniformity Compensation: The JVC KENWOOD system is considered "equivalent to the predicated device's one" in making visual performance "much better in the point of luminance (monochrome and color version) and chromaticity."
• Maximum Luminance (CCL550i2): The color monitor has a lower maximum luminance, but the document clarifies, "However DICOM Calibrated luminance is same as the predicated device. Then actual performance for diagnosis is the same." This is a crucial point, as the calibrated luminance is what's critical for diagnostic viewing.
• Contrast Ratio (CCL550i2): The color model's contrast ratio is higher, which is generally a positive difference.

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

This document does not contain information about a "test set" in the context of clinical images or patient data. The evaluation is focused on the technical performance specifications of the monitors themselves. Therefore, sample sizes for test sets in this sense are not applicable.

• Data Provenance: The data presented is from the manufacturer's (JVC KENWOOD Corporation) testing and comparison against the specifications of the predicate device. The company is based in Japan. This is more akin to bench testing of hardware specifications rather than a clinical study with patient data.

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

Not applicable. This is a technical comparison of monitor specifications, not an evaluation of diagnostic accuracy based on expert interpretation of images. The "ground truth" here is the adherence to technical standards and performance specifications, likely established through engineering measurements and adherence to industry standards like AAPM-TG18.

4. Adjudication Method for the Test Set

Not applicable, as no human reader studies or clinical test sets requiring adjudication are described.

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

Not applicable. This 510(k) summary is for medical display monitors and does not involve AI or reader studies.

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

Not applicable. This 510(k) summary is for medical display monitors and does not involve algorithms or AI performance.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is primarily technical specifications and performance measurements against established industry standards (e.g., DICOM, AAPM-TG18) and direct comparison with a legally marketed predicate device. The goal is to demonstrate that the new devices perform equivalently or better in terms of visual characteristics critical for medical image diagnosis.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being developed or trained described in this document.

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

Not applicable, as there is no training set mentioned in this document.

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