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The MFCD 118i Medical Flat Color Display is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners. The device is suitable for use in the MRI environment.

The MFCD 118i device is a digital image display designed for use in strong magnetic environments

The provided document describes a 510(k) premarket notification for the Barco MFCD 118i, a medical flat color display intended for use in MRI environments. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way one would describe for an AI/CADe device.

The 510(k) summary emphasizes the device's intended use as a tool for displaying and viewing digital images for review and analysis by trained medical practitioners, specifically in an MRI environment. The primary "proof" for this type of device in a 510(k) submission is typically its substantial equivalence to an already legally marketed predicate device, rather than a clinical performance study with specific acceptance criteria and outcome metrics.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type for training, and training set sample size) are not applicable to the information provided in this 510(k) summary for a display device.

However, I can extract the relevant information regarding the device's purpose and its basis for market approval:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: For a display device like the MFCD 118i, the "acceptance criteria" in the context of a 510(k) would generally relate to its ability to function safely and effectively within its intended environment (MRI) and display images adequately for medical review, demonstrating substantial equivalence to a predicate device. Specific quantitative performance metrics (e.g., contrast ratio, luminance uniformity, viewing angle, resolution) are usually covered in technical specifications and predicate comparisons, but are not detailed in this summary.
• Reported Device Performance:
  • Intended Use: To display and view digital images for review and analysis by trained medical practitioners.
  • Key Feature: Suitable for use in the MRI environment (compatible with strong magnetic environments).

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 for this device type within this document. This document does not describe a clinical performance study with a test set of data/images. The approval is based on substantial equivalence to a predicate device's design and intended use.

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. No ground truth establishment is described as this is not an AI/CADe device being evaluated for diagnostic accuracy.

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

• Not applicable. No 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 is a display device, not an AI/CADe system. No MRMC study was performed or is relevant to its approval.

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

• Not applicable. This is a display device, not an algorithm.

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

• Not applicable. No ground truth is established for this type of device's 510(k) submission.

8. The sample size for the training set

• Not applicable. This is a display device, not an AI/CADe system. There is no training set mentioned in relation to this device.

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

• Not applicable. No training set or ground truth establishment is described.

Summary of "Study" that Proves the Device Meets Acceptance Criteria:

The "study" or justification for the Barco MFCD 118i meeting its implied acceptance criteria is the 510(k) Substantial Equivalence Determination process conducted by the FDA. The submission likely included technical specifications, design documents, and possibly electromagnetic compatibility (EMC) testing reports to demonstrate its MRI compatibility and performance characteristics. However, these specific documents are not part of the provided summary.

The FDA determined that the MFCD 118i is substantially equivalent to Barco NV Display Systems MFCD 118 Medical Flat Color Display (K000291). This means the FDA concluded that the new device is as safe and effective as the predicate device (which was already legally marketed) and does not raise new questions of safety or effectiveness. The core "proof" lies in this comparison to an existing, approved device, rather than a de novo clinical trial with defined performance metrics and ground truth.

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