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RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.

RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 displays high-definition medical imaging.

The provided text describes a 510(k) summary for the EIZO NANAO CORPORATION's Color LCD Monitor, RadiForce RX320. This document primarily focuses on establishing substantial equivalence to a predicate device (RadiForce R31 and R31-C) rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of a clinical trial for an AI/CAD product.

The device is a medical display monitor, and its "performance" is evaluated based on its technical specifications compared to the predicate device. The acceptance criteria essentially revolve around demonstrating that the new device meets or exceeds the specifications of the predicate device, or that any differences do not raise new questions of safety and effectiveness.

Here's a breakdown based on your request, with the understanding that the nature of the device (a monitor) means "performance" and "ground truth" are interpreted differently than for an AI diagnostic algorithm:

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

Note: The acceptance criteria here are implicitly defined by the specifications of the predicate device. The new device demonstrates "substantial equivalence" by meeting or improving upon these key specifications.

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

   • This is not applicable to a medical display monitor's 510(k) submission. The "test set" would be the device itself being tested for its physical and electrical characteristics, not a set of medical images. The document does not describe a study involving medical 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):

   • Not applicable as no "ground truth" for medical image interpretation is established for this device submission. The device is a display, not a diagnostic algorithm.

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

   • Not applicable.

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 device is a display monitor, not an AI/CAD system.

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

   • Not applicable. This is a hardware device (monitor), not an algorithm. Its "standalone performance" refers to its technical specifications (brightness, contrast, etc.) as listed in the table, which are inherently "algorithm-only" in the sense that they are physical measurements of the device's output.

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

   • Not applicable. The "ground truth" for a monitor is its adherence to technical manufacturing specifications and industry standards for display performance (e.g., luminance, contrast, resolution), measured using calibrated equipment. This document does not detail the specific test methods or "ground truth" sources used to verify these specifications, but it is implied to be standard engineering and quality control procedures.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning algorithms.

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

   • Not applicable. No training set is involved for this device.

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The PrimeVue 21 inch 3MP Radiological Medical Display is intended to be used to display and view digital images for review and analysis by trained medical practitioners. However, This device must not be used in primary image diagnosis in mammography.

The PrimeVue 21 inch 3MP Color Display is a diagnostic display. The PrimeVue 21 inch 3MP Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.

This document indicates that the PrimeVue 21" 3MP Color Display is a diagnostic display intended for review and analysis of digital images by trained medical practitioners. It explicitly states that it must not be used in primary image diagnosis in mammography. The document is a 510(k) summary for the device.

However, the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. It is a regulatory submission for premarket notification, establishing substantial equivalence to predicate devices. It discusses:

• Manufacturer and device details: NDS Surgical Imaging, LLC, PrimeVue 21" 3MP Color Display.
• Intended Use: Display and view digital images for review and analysis by trained medical practitioners (excluding primary image diagnosis in mammography).
• Technological Characteristics: High-resolution Liquid Crystal Display (LCD) with electronic capabilities for review and analysis of high-resolution medical images.
• Substantial Equivalence: Listing predicate devices (Coronis, Mdnc 3120 (Barco) K061927; RadiForce R31-C (Eizo Nanao) K052344).
• Regulatory Classification: 21 CFR 892.2050/Procode 90LLZ (System, image processing, radiological).

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or studies from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance studies against specific acceptance criteria.

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FlexScan MX300W is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. FlexScan MX300W does not support the display of mammography images for diagnosis.

FlexScan MX300W is a 76cm (29.8") Color LCD display for medical image viewing and digital images viewing. MX300W displays high-definitions medical imaging.

The provided text is a 510(k) summary for a medical monitor (Color LCD Monitor, FlexScan MX300W). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about a study that assesses the device's performance against specific acceptance criteria related to its diagnostic accuracy or the impact of AI on human readers.

This type of submission for a display device primarily focuses on technical specifications and demonstrating that the new device is substantially equivalent to an already approved predicate device. It doesn't involve the kind of comparative effectiveness studies or standalone algorithm performance evaluations that would be documented for an AI-powered diagnostic device.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance: This would typically involve metrics like sensitivity, specificity, accuracy, or other performance indicators, which are not discussed for this monitor.
2. Sample size used for the test set and data provenance: No test sets are described for evaluating diagnostic performance.
3. Number of experts used to establish ground truth and their qualifications: Ground truth establishment is not relevant in this context for a monitor.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a display device, not an AI diagnostic algorithm, so no such study is described. There's no mention of AI or its effect on human readers.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a display device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on the monitor's technical characteristics (e.g., panel size, resolution, Digital Uniformity Equalizer, brightness) and its intended use for displaying digital images for diagnosis by trained medical practitioners, specifically excluding mammography. It establishes substantial equivalence to the RadiForce R31 monitor (K052344) based on these technical aspects.

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