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AMSure Enteral Delivery Pump Set with Spike is a device intended to deliver, through an enteral feeding pump, liquid nutrition formulas from a container to an enteral access device (a feeding tube).

AMSure™ Enteral Delivery Pump Set with Spike

The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSure™ Enteral Delivery Pump Set with Spike. This document confirms the device's substantial equivalence to a legally marketed predicate device and grants permission to market it.

This letter, typical for medical device regulatory approval, does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific ground truth methodologies. These details are usually found in the original 510(k) submission document, which is not provided here.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided document is a regulatory approval letter and not a technical study report.

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