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This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images,

The provided document is a 510(k) summary for a medical monitor (21HQ513D) and does not detail the acceptance criteria and study proving device performance as would be expected for an AI/ML-driven medical device. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.

However, it does include a "Bench Test – Performance Test Report" which lists various measurements and their test results. While not a study proving the device meets AI/ML acceptance criteria, it demonstrates the physical display characteristics meet predefined criteria.

Here's an interpretation based only on the provided text, focusing on the nearest relevant information:

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

The document does not specify quantitative acceptance criteria for each measurement, but rather indicates a "Pass" or "N/A" for each as well as a general statement that "All display characteristics of the 21HQ513D have met the pre-defined criteria."

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

This information is not provided in the document. The tests appear to be bench tests conducted on the device itself, rather than studies involving medical images or patient data.

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)

This information is not provided in the document. The tests seem to be objective measurements based on established standards (e.g., "FDA guidance 'Display Devices for Diagnostic Radiology'").

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

This information is not provided in the document.

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 such study was performed or described. The device is a medical monitor, not an AI-driven diagnostic aid. The document explicitly states: "No clinical studies were considered necessary and performed."

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

Not applicable. The device is a monitor, not an algorithm.

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

Not applicable. The performance tests are based on physical characteristics and compliance with industry standards and FDA guidance for display devices, not on medical ground truth.

8. The sample size for the training set

Not applicable. This device is a medical monitor, not an AI/ML diagnostic algorithm that requires a training set.

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

Not applicable.

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