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For the administration of fluids from a container into the patient vascular system through a vascular access device.

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I am sorry, but the provided text from the FDA letter pertains to a 510(k) premarket notification for an "TUBETECH® IV Administration Set," which is a medical device for administering fluids. It does not contain any information about a study proving that a device meets acceptance criteria for an AI/ML-based medical device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: The document describes a physical medical device (IV administration set), not an AI/ML device with performance metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable to this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is a routine FDA clearance letter confirming substantial equivalence of a general hospital device to a predicate device, focusing on regulatory compliance rather than performance study results for an AI/ML product.

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