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The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

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This looks like a 510(k) clearance letter for an Intravascular Administration Set, not a study describing the acceptance criteria and performance of a device, especially not one that would involve AI or expert readers.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter from the FDA stating that the "Dragon Heart Intravascular Administration Set" is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing. It does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size for a test set or data provenance.
3. Number of experts or their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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