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For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminate the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.

Nutrisafe® Enteral Feeding Tube

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Vygon Nutrisafe Enteral Feeding Tube". This type of document primarily confirms that a device is substantially equivalent to a predicate device already on the market and can be legally marketed. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the way described in your request (e.g., performance metrics like sensitivity, specificity, or AUC, and details about study design).

Therefore, I cannot extract the requested information from the provided text because it is not present. The letter focuses on regulatory clearance, not a performance study report.

To answer your questions, I would need a document that presents the results of a performance study for the device, including:

1. A table of acceptance criteria and the reported device performance: This would typically list metrics like tensile strength, flow rate, biocompatibility testing results, etc. against predefined acceptance limits.
2. Sample size used for the test set and the data provenance: Details on how many tubes were tested, where the materials came from, and if the testing was prospective (designed for the device) or retrospective (using existing data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): This is highly relevant for AI/imaging devices but unlikely for a physical medical device like an enteral feeding tube. For physical devices, ground truth is usually established through validated measurement methods or established standards.
4. Adjudication method: Again, more relevant to diagnostic interpretations than physical device performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a physical feeding tube. This is for AI-powered diagnostic tools comparing human performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical feeding tube.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a feeding tube, this would likely be physical measurements, chemical analyses, or biocompatibility tests.
8. The sample size for the training set: Not applicable for a non-AI physical device.
9. How the ground truth for the training set was established: Not applicable for a non-AI physical device.

In summary, the provided document is a regulatory clearance letter and does not contain the detailed performance study information you are asking for.

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