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The MFCD 2320 Medical Flat Color Display 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 MFCD 2320 is a diagnostic display. The MFCD 2320 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.

This submission describes a medical flat color display (MFCD 2320) and not an AI/ML device. Therefore, the specific information requested about acceptance criteria, study details, and AI/ML performance metrics cannot be found in the provided text. The document is a 510(k) summary for a display device, focusing on its substantial equivalence to a predicate device, and not on algorithmic performance or clinical study outcomes involving AI.

However, based on the information provided, here's what can be extracted and inferred about the device and regulatory process:

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

The provided text does not contain specific acceptance criteria or detailed performance data for the MFCD 2320 in the way one would describe an AI/ML device. For display devices, acceptance criteria would typically relate to technical specifications like resolution, brightness, contrast, color reproduction, stability, viewing angle, and conformity to display standards (e.g., DICOM Part 14). The document states the device is "a high resolution monitor with electronic capabilities for evaluation of high resolution medical images."

Since no specific performance metrics are given, a table cannot be constructed. The regulatory decision is based on substantial equivalence to a predicate device (MFCD 120, K000294), implying that the MFCD 2320 meets similar, if not improved, technical specifications and performance as its predicate.

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. This is a hardware display device, not an AI/ML algorithm that processes data. Therefore, there is no "test set" of medical images or data provenance in the context of an AI/ML study.

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 noted above, this is a display device, not an AI/ML algorithm requiring ground truth annotation for a test set.

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

Not applicable. This is a display device, not an AI/ML algorithm with a test set that requires expert adjudication.

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 is a display device, and the submission is not for an AI/ML device, so an MRMC comparative effectiveness study involving AI assistance would not have been performed or reported here.

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. This is a display device, not an AI/ML algorithm requiring ground truth.

8. The sample size for the training set

Not applicable. This is a display device, not an AI/ML algorithm that uses a training set.

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

Not applicable. This is a display device, not an AI/ML algorithm.

Summary of Device and Regulatory Context (from the provided text):

The MFCD 2320 is a medical flat color display intended for "displaying and viewing digital images for review by trained medical practitioners" (excluding digital mammography images). The regulatory submission (K040158) is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to an already legally marketed predicate device (MFCD 120, K000294). This means that the FDA determined the new device has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness. The approval allows the manufacturer to market the device under general controls, and possibly special controls if it were a Class II device.

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