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For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.

PROTOS® I.V. Administration Set (15 Drops/ML) and (60 Drops/ML)

The provided text is a 510(k) premarket notification letter from the FDA regarding an IV administration set. This type of document does not typically contain the detailed acceptance criteria and study results that would be used to prove a device meets those criteria.

510(k) clearances are primarily based on demonstrating substantial equivalence to an already legally marketed predicate device, rather than detailed performance studies proving specific acceptance criteria. The letter confirms that Globe Enterprises, Incorporated's PROTOS® I.V. Administration Set is substantially equivalent to existing devices.

Therefore, for your request, I must state that the provided document does not contain the information necessary to fulfill items 1 through 9.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not present. The letter is a regulatory approval, not a performance report.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
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 is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not applicable. This device is not an algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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