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The Vygon Neo-Sump is a collection and aspirate measuring device designed for the aspiration of the stomach contents in the newborn using wall line suction.

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This document is an FDA 510(k) clearance letter for the Vygon Neo-Sump, a collection and aspirate measuring device. It does not contain information about acceptance criteria or specific study details to prove the device meets those criteria.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This is a regulatory finding, not a performance study report.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• The number or qualifications of experts, or adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set or how its ground truth was established.

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