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This document is a 510(k) clearance letter from the FDA for a medical device called the "Wells Johnson Infusion System, Model 20-6000-00." This type of letter addresses substantial equivalence to a predicate device and allows the device to be marketed. It does not typically contain detailed information about specific performance acceptance criteria or detailed study results like those found in a clinical study report or a premarket approval (PMA) application.

Therefore, for the information requested in your prompt:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting specific performance acceptance criteria in the same way a clinical trial for a novel device would.
2. Sample sized used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this 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: Not applicable. This device is an "Infusion System," which is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in this document, as it pertains to performance studies not detailed here. The primary "ground truth" for a 510(k) is the performance of the predicate device to which it is compared for substantial equivalence.
8. The sample size for the training set: Not applicable/available.
9. How the ground truth for the training set was established: Not applicable/available.

In summary, the provided document is an FDA clearance letter based on substantial equivalence for a physical medical device (an infusion system). It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods that would be typically found in a clinical study report for a diagnostic device or AI algorithm.

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