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The MIVD 1218 18 Inch Grayscale Display Module is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

The MIVD 1218 is a diagnostic display. The MIVD 1218 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.

This document describes the 510(k) summary for the Barco MIVD 1218, an 18-inch grayscale display module. It's important to note that this is a display device, not an AI or image processing algorithm in the modern sense. Therefore, many of the typical AI/ML acceptance criteria and study components will not apply.

Based on the provided text, the device is a medical display, and the "study" demonstrating its performance would primarily involve technical specifications and conformance to industry standards for medical displays, rather than a clinical trial with patient data or expert read comparisons.

Here's an attempt to address your points based on the available information, noting where information is not present or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail a table of acceptance criteria or a "reported device performance" in the context of a clinical study assessing diagnostic accuracy. For a display device like this, acceptance criteria would typically revolve around technical specifications such as resolution, luminance, contrast ratio, uniformity, viewing angle, and compliance with standards like DICOM Part 14.

The document states:

• Proprietary Name: MIVD 1218
• Device Description: The MIVD 1218 is a diagnostic display
• Technological Characteristics: The MIVD 1218 device is a high-resolution monitor with electronic capabilities for evaluation of high-resolution medical images.

Without access to the full 510(k) submission, we cannot provide specific numerical values for these technical performance metrics. The core "performance" for a display is that it accurately and consistently presents medical images within specified parameters.

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

This information is not applicable and not provided as the device is a display monitor, not an algorithm that processes medical images from a test set of patient data. The "test" for this device would involve engineering verification and validation against technical specifications and performance standards, likely using test patterns, calibrated measurement devices, and internal quality control procedures.

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

This information is not applicable and not provided. As a display device, there's no "ground truth" derived from patient cases in the way there would be for an AI algorithm. Ground truth for a display refers to its technical specifications and performance against industry standards, typically verified by engineers and quality control personnel.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical cases, which is not relevant for a display device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This information is not applicable and not provided. An MRMC study assesses the diagnostic performance of human readers, typically with and without the assistance of an AI tool, across multiple cases. The Barco MIVD 1218 is a display device, not an AI tool, so such a study would not apply. Its effectiveness is in faithfully reproducing images, which can indirectly impact reader performance but isn't measured in this way.

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

This information is not applicable and not provided. This refers to the performance of an AI algorithm independent of human interaction. The MIVD 1218 is a hardware device (a monitor) and does not perform algorithmic analysis.

7. The Type of Ground Truth Used

This information is not applicable in the clinical sense. For a display, the "ground truth" for its performance evaluation would be its adherence to defined technical specifications and industry standards (e.g., DICOM Part 14 for grayscale display function, luminance uniformity, contrast ratio). This would be established through a combination of engineering design specifications, calibrated measurement instruments, and standardized test patterns.

8. The Sample Size for the Training Set

This information is not applicable and not provided. A training set is used for machine learning algorithms. The MIVD 1218 is a hardware device and does not involve machine learning.

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

This information is not applicable and not provided. As there is no training set for a hardware display device, there is no ground truth to establish for it.

In summary: The provided document is a 510(k) summary for a medical display. The clearance process for such a device focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to relevant standards, rather than clinical performance studies involving patient data and expert diagnoses in the way AI/ML devices are evaluated.

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