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The NIVTS (Nexus IV Tubing Sets) are intended for use to administer IV fluids/medication to the patients's vascular system through a needle-free system that aids in the elimination of needle-stick injury

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I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA to Nexus Medical, LLC for their Nexus Intravenous Tubing Sets.

This document primarily states that the FDA has reviewed the 510(k) premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. It outlines the regulatory classification, general controls, and other requirements the company must comply with.

The provided text does NOT contain any information regarding:

1. Acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance studies.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The core purpose of this document is a regulatory approval notice based on substantial equivalence, not a detailed report of performance testing or clinical studies.

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