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The AXIS-V 5MP Radiological Monochrome Medical Display is intended to be used to display and view digital images, including digital mammography, for review and analysis by trained medical practitioners.

The AXIS-V 5MP Monochrome Display is a diagnostic display.
The AXIS-V 5MP Monochrome 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.

The provided text is a 510(k) summary for a medical display device, the AXIS-V 5MP Monochrome Display. It does not contain information about acceptance criteria, study data, sample sizes, expert ground truth establishment, or any comparative effectiveness studies as requested in your prompt. This document serves as a regulatory submission for premarket notification, establishing substantial equivalence to existing devices rather than detailing performance study outcomes.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

• Manufacturer and Contact Information: National Display Systems, LLC.
• Device Description: AXIS-V 5MP Monochrome Display, a high-resolution Liquid Crystal Display (LCD) for viewing medical images, including digital mammography.
• Intended Use: To display and view digital images for review and analysis by trained medical practitioners.
• Classification and Product Code: 21 CFR 892.2050/Procode 90LLZ (Picture archiving and communications system).
• Substantial Equivalence: Claimed against Coronis 5MP (Barco) K042221 and RadiForce G51 (Eizo Nanao) K042755.
• FDA Communication: A letter from the FDA acknowledging review of the 510(k) and determining substantial equivalence, allowing the device to be marketed under general controls.

To provide the information you're looking for, I would need a different document, such as a clinical study report, a detailed performance evaluation report, or a more comprehensive technical submission that outlines the testing and validation performed on the device.

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The AXIS Radiology Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS 1MP, 2MP and 3MP displays are not intended for use with FFDM.

The AXIS Monochrome Display is a diagnostic display. The AXIS Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images.

This 510(k) pertains to monochrome medical display monitors and therefore doesn't involve a study with acceptance criteria in the typical sense of algorithm performance. The FDA clearance is based on substantial equivalence to predicate devices. This means the new device (AXIS I, II, III, and V Monochrome Displays) has the same intended use and technological characteristics as already legally marketed devices, and they do not raise new questions of safety or effectiveness.

Therefore, many of the typical questions for AI/algorithm-based devices (like sample sizes, ground truth establishment, MRMC studies) are not applicable here.

Here's a breakdown of what can be extracted and how it relates to acceptance criteria in this context:

1. Table of Acceptance Criteria and Reported Device Performance:

For a display device, "acceptance criteria" primarily revolve around demonstrating performance similar to predicate devices and meeting relevant display standards. The document doesn't provide specific numerical performance metrics for the AXIS displays, but rather establishes equivalence to predicate devices.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not applicable. There was no specific "test set" of medical images or patient data used to evaluate the device's diagnostic performance in a clinical study. The evaluation is based on technical specifications and comparison to predicate devices.
• Data Provenance: Not applicable.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for the substantial equivalence of a display monitor. The evaluation focuses on the technical specifications and intended use of the display itself, not its impact on diagnostic accuracy, which is presumed to be equivalent to the predicate devices.

4. Adjudication Method:

• Not applicable.

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

• No. An MRMC study was not done. These studies are typically conducted for AI algorithms or new diagnostic methodologies to assess their impact on human reader performance. For a display device, the focus is on its technical specifications and equivalence, not its direct impact on reader performance beyond providing a clear image comparable to existing displays.

6. Standalone Performance Study:

• No. A standalone algorithm performance study was not done because this is a hardware device (a display monitor), not an algorithm or AI system. Its "performance" is inherently tied to its technical specifications and its ability to display images, which is assumed to be equivalent to the predicate devices.

7. Type of Ground Truth Used:

• Not applicable. The "ground truth" for this submission is the technical specifications and regulatory status of the predicate devices. The new device's compliance with similar specifications and its intended use form the basis for its clearance.

8. Sample Size for the Training Set:

• Not applicable. The AXIS Monochrome Display is a hardware device; it does not involve machine learning or an algorithm that requires a training set.

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

• Not applicable.

In summary: This 510(k) is a typical substantial equivalence submission for a medical display device. The "acceptance criteria" are implicitly met by demonstrating that the new device shares the same intended use and similar technological characteristics to already cleared predicate devices, without raising new concerns about safety or effectiveness. Clinical performance studies are not required for this type of submission.

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The Nova Radiology Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The Nova 5MP display is currently not cleared in the U.S. for use with Ful Field Digital Mammography (FFDM). The Nova 1MP, 2MP and 3MP displays are not intended for use with FFDM

The Nova - Radiology Monochrome Display is a diagnostic display.

The provided text is a 510(k) summary for a medical device called "Nova - Radiology Monochrome Display." It describes the device, its intended use, and states that it is substantially equivalent to other marketed predicate devices. However, the document does not contain acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk medical devices in the US. This process typically involves showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and does not raise different questions of safety and effectiveness. It often relies on a comparison table of features and specifications rather than a new clinical study with specific acceptance criteria that the device's performance needs to meet.

Therefore, for aspects of your request that relate to acceptance criteria and performance studies, the information is not available in the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Not available in the provided text. The document describes the device's technological characteristics (high resolution, LCD, monochrome, image restoration) and intended use, and lists predicate devices for comparison. It does not provide specific performance metrics or acceptance thresholds that the device was tested against in a formal study.

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

• Not available in the provided text. A formal test set and associated data provenance are typically part of a performance study, which is not described here.

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 available in the provided text. Ground truth and expert adjudication are relevant for studies assessing diagnostic accuracy, which is not the focus of this 510(k) submission for a display device.

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

• Not available in the provided text.

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 and not available in the provided text. This is a passive display device, not an AI-powered diagnostic tool. MRMC studies are not relevant for this type of product.

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

• Not applicable and not available in the provided text. This is a display device, not an algorithm.

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

• Not applicable and not available in the provided text.

8. The sample size for the training set

• Not applicable and not available in the provided text. This is not an AI/ML device that requires a training set.

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

• Not applicable and not available in the provided text.

Summary of available information from the provided text:

• Device Name: Nova - Radiology 18.1" Monochrome Display (1MP), Nova - Radiology 20.1" Monochrome Display (2MP), Nova - Radiology 20.8" Monochrome Display (3MP), Nova - Radiology 21.3" Monochrome Display (5MP)
• Intended Use: To display and view digital images for review and analysis by trained medical practitioners. (Note: Specific limitations for FFDM use are mentioned for different models).
• Technological Characteristics: High-resolution, Liquid Crystal Display (LCD) with image restoration for viewing and analysis of high-resolution medical images.
• Regulatory Pathway: 510(k) Premarket Notification based on substantial equivalence.
• Predicate Devices:
  • Nova 1MP = Coronis 1MP (Barco) K023340
  • Nova 2MP = Coronis 2MP (Barco) K023322 and Dome C2 (Planar Systems) K032202
  • Nova 3MP = Coronis 3MP (Barco) K013922 and Dome C3 (Planar Systems) K032638
  • Nova 5MP = Coronis 5MP (Barco) K023341 and Dome C5i (Planar Systems) K032202
• Conclusion: The FDA determined substantial equivalence, allowing the device to be marketed. This determination is based on the comparison of the new device's characteristics against the legally marketed predicate devices, not on the results of a new performance study with explicit acceptance criteria.

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