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The E-2320 PA S is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

E-2320 PA S is a display for medical viewing. It consists of 2 components: E-2320 PA S is a 20.1″ grayscale display. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.

The provided document is a 510(k) summary for the Barco E-2320 PA S medical flat panel display. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data for the device itself.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance in the way you've requested for a device that performs a diagnostic task. The study described is a comparison against a predicate device to establish substantial equivalence.

Here's an assessment based on the provided text:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics for the E-2320 PA S display in a format that would typically be found for a diagnostic algorithm. The acceptance criteria for this submission are related to demonstrating substantial equivalence to the predicate device, K051902 (Barco E 2621), primarily based on technical characteristics, general function, application, and intended use.

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 display device, not a diagnostic algorithm that processes a test set of medical images for performance evaluation in the traditional sense. The "study" here is a technical comparison for regulatory purposes.

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. Ground truth is not established for image interpretation by clinicians in this submission. The "ground truth" for substantial equivalence would be the technical specifications and performance of the predicate device.

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 is a display device, not an AI-powered diagnostic tool.

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

Not applicable.

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

Not applicable in the context of image interpretation. The "ground truth" for substantial equivalence is the technical specifications and performance data of the predicate device (Barco E 2621).

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable.

Summary of the "study" for this device:

The "study" presented in this 510(k) submission is a declaration of substantial equivalence to an existing legally marketed device (predicate device).

• Predicate Device: Barco E 2621 (510(k) number: K051902)
• Comparison: The E-2320 PA S is compared to the E 2621.
• Key Finding: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."
• Differences noted: The E-2320 PA S has a different LCD panel with a smaller screen size compared to the predicate device. The NioWatch software and other components are the same.
• Conclusion: The FDA reviewed the information and determined the device is substantially equivalent to the predicate device.

To reiterate, this document describes a regulatory pathway for a display monitor, not a diagnostic algorithm. Therefore, the detailed performance metrics and study designs typically associated with AI or diagnostic device evaluations are not present.

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