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This product is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.

RadiForce GX540 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. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX540" such as "GX540-CLAR", a model whose backlight is Clear Base with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX540 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 GX540.

The provided text describes a 510(k) premarket notification for a medical display monitor, the Eizo RadiForce GX540. It focuses on demonstrating substantial equivalence to a predicate device (RadiForce GX530) rather than providing extensive details about acceptance criteria and a study proving the device meets those criteria, which would typically be found in a clinical or performance study report for an AI/software device.

However, based on the performance testing section, we can infer some details and present them in the requested format, acknowledging where information is not explicitly provided.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" but rather lists "performance testing" conducted to verify the device's characteristics, especially where it differs from the predicate device (backlighting). The performance details are presented as verification of conformance to established guidelines and measurements.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The tests were bench tests on the device itself, not image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/not provided as the tests were technical measurements of display performance characteristics, not an assessment of medical images by experts. The "visual check" of artifacts likely refers to technical personnel inspecting the display, guided by the TG18 guideline, rather than medical experts establishing a "ground truth" for patient diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/not provided. The tests involved objective measurements against established technical standards (like DICOM GSDF and AAPM TG18 guidelines), not expert adjudication of diagnostic findings.

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 device is a medical display monitor, not an AI or CAD system designed to assist human readers in image interpretation. The study focused on the display's technical performance characteristics.

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

No, this is not applicable. The device is a display monitor, not an algorithm. The "standalone" performance here would refer to the monitor's technical specifications and performance, which were indeed tested.

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

The "ground truth" in this context refers to established technical standards and industry guidelines. Specifically:

• DICOM GSDF (Grayscale Standard Display Function): A standardized luminance response curve essential for consistent medical image display.
• AAPM Task Group 18 (TG18) guideline: A comprehensive set of recommendations and test patterns for assessing the performance of medical displays.

These are objective, measurable technical standards, not clinical "ground truth" derived from patient data.

8. The sample size for the training set

This information is not applicable/not provided. This is a hardware device (display monitor), not a machine learning algorithm that requires a training set.

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

This information is not applicable/not provided. As above, there is no training set for a display monitor.

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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.

The RadiForce RX440 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2,560 x 1,600 pixels (4MP) with a pixel pitch of 0.2505 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. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX440" such as "RX440-AR", a model with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX440 based on the OC 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 RX440.

Here's a breakdown of the acceptance criteria and study information for the Eizo RadiForce RX440 monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing performed on the RadiForce RX440. It does not specify a "test set" in terms of patient data or images. The testing was conducted on the device itself.

• Sample Size for Test Set: Implicitly, the physical device(s) of the RadiForce RX440 model. Not specified as a quantity, but suggests testing was performed on at least one unit.
• Data Provenance: The testing was performed by Eizo Nanao Corporation (Japan) on their own manufactured device. This is a prospective evaluation of the manufactured device's physical characteristics.

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

This type of information is not applicable to the described performance testing. The "ground truth" for these tests are objective technical specifications and measurement standards (e.g., DICOM GSDF, TG18 guideline specifications, FDA guidance). Expert consensus is not relevant for verifying these physical and performance aspects of a display monitor.

4. Adjudication Method for the Test Set

This is not applicable as there was no 'test set' of expert-reviewed data. The performance was assessed against objective technical standards and guidelines.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is outside the scope of testing a medical display monitor.

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

No, a standalone (algorithm-only) performance test was not done. This device is a display monitor, not an algorithm. Its performance is evaluated independently of human interpretation of displayed images, but it relies on a human user for its intended purpose.

7. The Type of Ground Truth Used

The ground truth used for these tests was objective technical specifications and industry standards/guidelines. These include:

• DICOM GSDF (Grayscale Standard Display Function)
• AAPM Task Group 18 (TG18 guideline) 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
• Manufacturer's internal specifications for pixel defects/faults.

8. The Sample Size for the Training Set

This is not applicable. The RadiForce RX440 is a display monitor, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for a display monitor.

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The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

The RadiForce RX840-MG 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. With the matrix size (or resolution) of 4.096 x 2.160 pixels (8MP), the RX840-MG is an alternate replacement for traditional dual head 5MP display installations.

Here's a breakdown of the acceptance criteria and study information for the EIZO RadiForce RX840-MG, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The test results showed that the RadiForce RX840-MG has display characteristics equivalent to those of the predicate device, RadiForce GX530 except 4 items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX840-MG meet the pre-defined criteria when criteria are set." The specific 4 items and their exact deviation are not detailed, but the overall conclusion is that any differences do not negatively impact performance or safety.

Study Details

1. Sample Size used for the test set and the data provenance:

   • The study involved bench testing of the RadiForce RX840-MG display monitor.
   • The "test set" in this context refers to the physical device itself and its components, not a dataset of medical images or patient data.
   • Data provenance: Not directly applicable as this is a device performance test, not a clinical study with patient data. The device itself is manufactured by EIZO NANAO CORPORATION in Japan.

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

   • This was a bench test of a display monitor, not a study requiring expert readers to establish ground truth for medical diagnoses.
   • The "ground truth" was established by objective measurements against established technical guidelines (AAPM Task Group 18, DICOM GSDF) and pre-defined criteria. There is no mention of human experts being used to establish ground truth for the test set itself.

3. Adjudication method for the test set:

   • Not applicable. As a bench test of a display monitor, there was no adjudication of discrepant readings or interpretations. The performance was measured directly.

4. 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, a MRMC comparative effectiveness study was not done.
   • This submission is for a medical display monitor, not an AI-powered diagnostic tool. The purpose was to show the display's technical performance characteristics.

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

   • Yes, the testing was effectively a "standalone" performance evaluation of the monitor itself, without any human interaction influencing the measurement of its technical specifications. However, it's not an "algorithm-only" performance as it's a hardware device. The device's performance was evaluated independently against technical standards.

6. The type of ground truth used:

   • Technical Benchmarks and Standards: The ground truth was based on established quality control guidelines and standards for medical displays, specifically:
     • DICOM GSDF (Grayscale Standard Display Function)
     • AAPM Task Group 18 (TG18 guideline)
     • Pre-defined criteria set by the manufacturer for various display characteristics.

7. The sample size for the training set:

   • Not applicable. This is a bench test for a hardware device, not a machine learning model that requires a training set. The device itself is manufactured, not "trained."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a hardware display monitor.

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The RadiForce RX340 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 does not support the display of mammography images for diagnosis.

The RadiForce RX340 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.21075 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 RX340 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 RX340.

The provided document is a 510(k) summary for the EIZO RadiForce RX340 3MP Color LCD Monitor. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial for an AI-powered diagnostic device would.

This document describes a medical display monitor and its substantial equivalence to a predicate device, not an algorithm that generates a diagnosis or interpretation. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.

Instead, the submission focuses on technical characteristics and performance benchmarks compared to a predicate device to demonstrate substantial equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" against which an algorithm's performance is measured. Instead, it compares the proposed device's technical specifications and performance to those of a predicate device (RadiForce RX320). The "acceptance criteria" are implicitly that the proposed device must perform at least as well as the predicate device in key display characteristics, or that any differences do not affect safety or effectiveness.

2. Sample Size for the Test Set and Data Provenance

Not applicable in the context of an algorithm's test set. The "test set" here refers to the actual monitor units evaluated. The document states: "EIZO NANAO CORPORATION performed a range of system and performance tests to ensure that the RadiForce RX340 performs in accordance with its specifications." It does not specify the number of units tested, but it is typical for manufacturers to test a representative sample during design validation. Data provenance is internal testing by the manufacturer.

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

Not applicable. "Ground truth" in this context would relate to the physical characteristics of the display itself (e.g., luminance, resolution, color accuracy), which are measured using calibrated instruments, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. Measurements are objective and do not require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is relevant for comparing the diagnostic performance of human readers with and without AI assistance for interpreting medical images. The RadiForce RX340 is a display monitor, not an AI diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. The device is a monitor, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for validating the monitor's performance is based on objective physical measurements of its display characteristics (e.g., luminance, color temperature, resolution, DICOM GSDF compliance) using calibrated testing equipment. It also includes compliance with international safety and EMC standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (monitor), not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a monitor.

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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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The RadiForce GX240 is intended to be used in displaying and viewing digital images by trained medical practitioners. The RadiForce GX240 does not support the display of mammography images for diagnosis.

The RadiForce GX240 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 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.

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX240" such as "GX240-CL", a model whose backlight is Clear Base (one of tints) although the hardware design, components and labeling remain unchanged.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX240 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 GX240.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EIZO RadiForce GX240 monitor, structured according to your request:

Acceptance Criteria and Study for EIZO RadiForce GX240

The EIZO RadiForce GX240 is a 2MP Monochrome LCD Monitor intended for displaying and viewing digital medical images by trained medical practitioners, excluding mammography images. The submission emphasizes its substantial equivalence to the predicate device, RadiForce GS220, based on performance testing. Because this is a medical display, the acceptance criteria largely revolve around display performance standards rather than diagnostic accuracy metrics typically associated with AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of image data for diagnostic performance. The testing was performed on the device itself (RadiForce GX240) to verify its display characteristics. It's a bench performance study of the hardware, not an evaluation of diagnostic accuracy using a dataset of medical images.

• Sample Size for Test Set: Not applicable in the typical sense of medical image evaluation. The tests were performed on one or more RadiForce GX240 monitors. The specific number of individual monitors tested is not provided, but it would likely be a small, representative sample for engineering and quality control purposes.
• Data Provenance: Not applicable. No patient data or medical images from specific countries were used for evaluation of the device's diagnostic performance. The tests involved image quality metrics generated and measured on the display.
• Retrospective or Prospective: Not applicable as no patient data was used for evaluation.

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

Not applicable. This evaluation focuses solely on the technical performance of a display device, not on diagnostic accuracy of medical images. Therefore, clinical expert ground truth for a test set of images was not required or utilized in this study. The "ground truth" for the display tests would be the specifications and standards (e.g., DICOM GSDF, TG18 guidelines).

4. Adjudication Method for the Test Set

Not applicable. As no human diagnostic performance was evaluated against a ground truth, no adjudication method like 2+1 or 3+1 was used.

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

No. An MRMC comparative effectiveness study was not performed. This type of study is designed to evaluate changes in human reader diagnostic performance (e.g., sensitivity, specificity) with and without AI assistance or different display types, which is not the scope of this submission. The submission confirms "No animal or clinical testing was performed on the RadiForce GX240."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The RadiForce GX240 is a display monitor, not an AI algorithm. Therefore, a standalone algorithm performance study was not relevant or performed.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was based on established industry standards and guidelines for medical displays:

• Expert Consensus / Industry Standards: AAPM Task Group 18 (TG18 guideline) for display performance (DICOM GSDF conformance, luminance and chromaticity non-uniformity, visual artifacts).
• Regulatory Guidance: FDA Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions (for chromaticity measurements).
• Manufacturer Specifications: Agreements with the LCD panel manufacturer regarding acceptable pixel defects/faults.

8. Sample Size for the Training Set

Not applicable. The RadiForce GX240 is a hardware display device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. The monitor is factory calibrated to comply with standards.

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

Not applicable, as there is no training set for a display device. The factory calibration settings, which could be conceptually linked to "training" the display, are established based on the display's inherent physical properties and are tuned to conform to the aforementioned industry and regulatory standards.

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The RadiForce GX340 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 specified for digital mammography system.

The RadiForce GX340 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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.

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX340" such as "GX340-CL", a model whose backlight is Clear Base (one of tints) .

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX340 based on several OC guidelines. The RadiCS and its subset. RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX340.

Acceptance Criteria and Study for EIZO RadiForce GX340 Monitor

This document describes the acceptance criteria and the study conducted for the EIZO RadiForce GX340 3MP Monochrome LCD Monitor. The information is based on the provided Traditional 510(k) Summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device (RadiForce GS320) by showing that the new device meets or exceeds the predicate's performance in key areas and that any differences do not affect safety or effectiveness. The performance is largely framed as either "same as" or "higher than" the predicate.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of an algorithmic assessment with a specific sample size of medical images. The evaluation is focused on the device's physical and technical characteristics as a display monitor.

The "study" described is a bench testing and technical comparison against a predicate device. There is no indication of clinical image data being used as a "test set" in the typical AI/CAD sense.

Data provenance is not applicable as the evaluation is primarily hardware-focused, comparing the new monitor's specifications and performance to a previous model.

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

Not applicable. This submission is for a medical display monitor, not an AI/CAD algorithm that requires expert-established ground truth on medical images. The "ground truth" here relates to engineering specifications and performance standards (e.g., luminance, resolution, DICOM compliance).

4. Adjudication Method for the Test Set

Not applicable. As stated above, this is a hardware device submission, not an AI/CAD algorithm requiring image-based adjudication.

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

No. An MRMC study was not conducted as this is a medical display monitor, not an AI/CAD system designed to assist human readers. The context is ensuring the display device itself is equivalent to or better than its predicate in showing images accurately.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a display monitor. While it has embedded firmware and calibration features (like the Built-in Front Sensor for automatic grayscale calibration), it is not an "algorithm" in the sense of an independent diagnostic or assistive software. Its performance is evaluated on its ability to accurately render images, not to interpret them autonomously.

7. Type of Ground Truth Used

The "ground truth" used in this submission is primarily based on:

• Engineering specifications and measurements: The device's luminance, resolution, pixel pitch, active area, and tone curve adherence to DICOM GSDF are objectively measured and compared.
• Industry standards: Compliance with DICOM GSDF, international safety, and EMC standards.
• Comparison to predicate device's established performance: The predicate (RadiForce GS320) serves as a benchmark for acceptable performance.

8. Sample Size for the Training Set

Not applicable. Since this is a hardware device (display monitor) and not an AI/CAD algorithm, there is no "training set" in the context of machine learning. The monitor is designed and manufactured to meet specific engineering specifications.

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

Not applicable. As there is no training set for an AI/CAD algorithm, there is no ground truth established for it in this context. The manufacturing and testing processes ensure the monitor meets its stated specifications and complies with relevant standards.

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The RadiForce RX240 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 does not support the display of mammography images for diagnosis.

The RadiForce RX240 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1200 x 1600 pixels (2MP) with a pixel pitch of 0.270 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 RX240 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 RX240.

The provided text describes a 510(k) submission for a medical monitor, the EIZO RadiForce RX240. However, it does not contain information about acceptance criteria for device performance, nor a study proving it meets such criteria in the context of AI/human reader performance or standalone algorithm efficacy.

The document focuses on demonstrating substantial equivalence to a predicate device (RadiForce RS210) based on technological characteristics and intended use. The performance testing mentioned is "bench testing" comparing image quality characteristics of the proposed device with the predicate device, and validation of the overall design against safety and EMC standards. It explicitly states: "None of the tests revealed behaviors inconsistent with the expected performance."

Therefore, based on the provided input, I cannot fill out the requested table or sections related to acceptance criteria, AI performance studies, or ground truth establishment for such studies.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Matrix size: 1200 x 1600 pixels (same)
• Active area: 324.0 mm x 432.0 mm (same)
• DICOM calibrated luminance: 400 cd/m² (higher than predicate's 150 cd/m²)
• Typical maximum luminance: 760 cd/m² (higher than predicate's 300 cd/m²)
• Backlight: LED (newly employed, mercury-free, less power, slower deterioration)
• Image display: In accordance with DICOM GSDF
• Interface: Digital (DVI or DisplayPort only, no analog)
• QC Software: Same as predicate
• Backlight Sensor (BS): Same as predicate
• Built-in Front Sensor (IFS): Enables automatic grayscale calibration (new feature)
• Overall design: Validated in accordance with internationally recognized safety and EMC standards by independent and in-house facilities. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This information is relevant for studies involving medical image data and diagnostic performance (e.g., AI algorithms). The provided document describes a hardware device (monitor) and its quality control software. The performance testing mentioned is at the device specification level (e.g., luminance, resolution, compliance with standards), not clinical performance or diagnostic accuracy using a test set of medical images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. As above, this pertains to clinical validation studies involving diagnostic interpretation, which is not the focus of this 510(k) submission for a medical display monitor.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided.

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. The document does not describe an MRMC study or any AI component designed to assist human readers. The device is a display monitor.

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

• No. The document does not describe an algorithm for standalone performance.

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

• Not applicable / Not provided. The "ground truth" for this device's performance relates to its technical specifications and compliance with display standards (e.g., DICOM GSDF, safety/EMC standards), not clinical diagnostic accuracy.

8. The sample size for the training set

• Not applicable / Not provided.

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

• Not applicable / Not provided.

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The RadiForce RX840 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 does not support the display of mammography images for diagnosis.

The RadiForce RX840 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 4096 x 2160 pixels (8MP), spacious enough to display e.g. two 3MP radiological images and other clinical information side by side without obtrusive bezels.

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.

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX840" such as "RX840-AR", a model with an Anti-Reflective coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX840 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 RX840.

The provided text describes a 510(k) submission for the EIZO RadiForce RX840 8MP Color LCD Monitor. It does not contain information about a study with acceptance criteria for a device that uses AI or a human-in-the-loop component. Instead, it focuses on demonstrating substantial equivalence of the RX840 monitor to a predicate device (FlexScan MX300W) based on technological characteristics and performance benchmarks.

Therefore, many of the requested sections about AI-specific criteria, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this document. The document describes a display monitor, not an AI diagnostic tool.

Here's a breakdown of the information that is present or can be inferred, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in the typical sense for a diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, it focuses on demonstrating that the proposed device (RadiForce RX840) meets or exceeds the performance characteristics of its predicate device, the FlexScan MX300W. The "acceptance criteria" here are implicitly tied to the performance of the predicate device.

The document states: "The RadiForce RX840 can be said to have at least the same display performances as those of the predicate device by default..." and "The specifications of the primary component employed by the proposed device are superior to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness." This indicates that the "acceptance criteria" were met by demonstrating equivalence or superiority to the predicate device's established performance without introducing adverse effects.

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

Not applicable. This is not a study involving patient data or a test set in the context of an AI algorithm. The performance evaluation is based on device specifications and benchmark testing of the monitor hardware and software.

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

Not applicable. There is no "ground truth" establishment in the context of diagnostic interpretation for this monitor's submission. The "ground truth" for monitor performance would be established by objective measurements and adherence to technical standards.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set or adjudication process is 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

No. This document describes a monitor, not an AI system. Therefore, an MRMC comparative effectiveness study regarding AI assistance is not applicable.

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

No. This is a display monitor, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is typically established by:

• Engineering specifications and objective measurements: Calibrated luminance, resolution, pixel pitch, tone curve adherence (DICOM GSDF), color accuracy, etc.
• Adherence to recognized standards: Safety (e.g., IEC 60601-1) and EMC standards.
• Comparison to predicate device performance: Demonstrating that the new device's performance characteristics are equivalent or superior without raising new safety or effectiveness concerns.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI algorithm.

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

Not applicable.

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The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.

The RadiForce GX530 is a 5MP monochrome LCD monitor for viewing medical images including those of digital mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles. The matrix size (or resolution) of the panel is 2560 x 2048 pixel pitch is 0.165 mm, both of which are the same as those of displays approved so far for digital mammography including the predicate device, RadiForce GS10. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF) and a specific luminance range, 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 GX530 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 GX530.

The provided document is a 510(k) summary for the EIZO RadiForce GX530 5MP Monochrome LCD Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not a study evaluating the performance of AI. Therefore, it does not contain information typically found in a study that proves a device meets acceptance criteria related to AI performance.

The document discusses the technical characteristics and intended use of the monitor and compares it to a predicate device (RadiForce GS510, K062054) to establish substantial equivalence.

Here's an breakdown of the information provided, framed against your request for acceptance criteria and study details, highlighting what is and isn't present:

Context: This document is about a medical display monitor, not an AI algorithm. Therefore, many of your requested items regarding AI performance, training sets, ground truth methodology, and expert adjudication are not applicable or present in this filing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for a study in the way one would for an AI algorithm. Instead, it focuses on demonstrating that the RadiForce GX530 meets performance requirements by being substantially equivalent to its predicate device.

The performance characteristics discussed are primarily related to monitor specifications and functionality:

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

• Not Applicable. This document describes a medical monitor, not an AI device evaluated with a test set of data. The "test set" in this context refers to the monitor's functionality and compliance, not diagnostic image data.

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

• Not Applicable. Ground truth for diagnostic images is not a concept applied to the evaluation of a display monitor in this context. The "truth" here relates to the monitor's adherence to technical specifications and ability to display images correctly.

4. Adjudication method for the test set

• Not Applicable. No expert adjudication of diagnostic interpretations is described, as this is a hardware device submission.

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 is not an AI device, so MRMC studies involving AI assistance are not relevant or present in this document.

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

• Not Applicable. No algorithm performance is being evaluated.

7. The type of ground truth used

• Technical Specifications and Regulatory Standards: The "ground truth" for this device's evaluation is its adherence to technical specifications, industry standards (like DICOM GSDF), and safety/EMC regulations. The basis for comparison is the predicate device's established performance. The document states "precision data of the calibration with an external sensor and with the IFS is provided as one of the validation data," indicating measurements against known photometric standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI algorithm.

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

• Not Applicable. No training set for an AI algorithm exists for this device.

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