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The Creavo Vitalscan Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.

The Creavo Vitalscan Magnetocardiograph is a transportable device, when not in use, which includes a scan head containing multiple sensors, a moveable arm, electronics, software, user touch screen, power supply, and a rechargeable battery. The wheeled chassis and handles allow the device to be transportable between patient beds. During use, the device is placed adjacent to the patient bed. The color touch screen allows the user to enter patient information (e.g., patient name and scan information) and serves as the visual display unit of the numerical and graphical results during testing. The device also incorporates the use of single use standard ECG electrodes and reusable AHA patient lead wires. The ECG electrodes, are used for gating of the magnetocardiograph signal with the patient's cardiac electrical signal and are used to assist triggering the device electronics and software.

The provided text describes a 510(k) premarket notification for the Creavo Vitalscan Magnetocardiograph. It confirms the device's substantial equivalence to a predicate device based on its intended use, design characteristics, and performance testing against various standards. However, the document does not contain information regarding acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy), nor does it describe a study that uses a test set, ground truth established by experts, or any details about human reader performance.

Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred or explicitly stated based on the provided document:

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

This information is not provided in the document. The document lists performance tests against general standards (IEC 60601 series, IEC 62366) and states that "design specifications were met," but it does not specify quantitative acceptance criteria or the reported performance relative to those 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 document mentions "performance tests" and "software validation" but does not detail any specific clinical or non-clinical test sets, their sample sizes, or data provenance.

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. No mention of experts or ground truth establishment for a test set is made.

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

This information is not provided in the document. The device description and performance data summary focus on the device's ability to record magnetocardiograms and meet safety/EMC standards, not on its use in interpreting data or assisting human readers. There is no mention of AI.

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

The document does not detail any "standalone" algorithm performance study in the context of diagnostic accuracy. It states the device "measures and displays the magnetic signals," implying it's a measurement tool. Performance tests mentioned are related to safety, EMC, and usability, not diagnostic accuracy of an algorithm.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The device is not described as involving machine learning or a "training set."

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

This information is not provided in the document.

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