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The intended use of the NOGA system is catheter-based cardiac mapping.

The NOGA system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG, intracardiac electrograms and intracavity or intravascular blood pressure may also be displayed in real time on the display screen.

The Biosense NOGA system is designed to acquire, and display electro-mechanical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of a plurality of intracardiac electrograms with their respective endocardial locations. In the NOGA system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a Biosense sensor. The NOGA system also allows presentation of electroanatomical maps as a function of time over the cardiac cycle (electromechanical maps).

The NOGA system enables cardiac mapping using a non-fluoroscopic catheter tip location technology. The NOGA system also uses this technology to collect additional information about the heart chamber geometry as a function of time over the cardiac cycle.

The provided text is a 510(k) summary for the Biosense NOGA system. It describes the device, its intended use, regulatory compliance, and a statement regarding testing. However, it does not contain specific information on acceptance criteria, a detailed study proving performance, sample sizes for test and training sets, expert qualifications, ground truth establishment methods, or whether MRMC or standalone studies were conducted.

The document states:
"The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness."

This is a general statement of equivalence to a predicate device (Biosense NOGA system 510(k) No. K960542), but it does not provide the specifics requested in your prompt.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method: Not provided.
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 provided. The NOGA system is a cardiac mapping system, not an AI-assisted diagnostic tool that would typically involve human readers in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed, though the "non-clinical bench and animal testing" would likely include standalone performance evaluations. No specifics are given.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

The document is a regulatory submission for premarket notification (510(k)), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific study report with all the specifics requested.

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