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The Nasogastric Bridle System with Maynetic Retrieval is intended to prevent inadvertent displacement or removel of nas sogastric to tubes from patients requiring naso enteric feed

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This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on:

• Device Name: Nasogastric Bridle System with Magnetic Retrieval
• Applicant: Applied Medical Technology, Inc.
• Regulatory Information: 510(k) number (K030784), regulation number (21 CFR §876.5980), regulatory class (II), product code (78 KNT).
• FDA Determination: Substantial equivalence to a legally marketed predicate device.
• Indications for Use: To prevent inadvertent displacement or removal of nasogastric tubes from patients requiring naso-enteric feeding.

To answer your questions, I would need access to the 510(k) Premarket Notification submission itself, which would contain the performance data and study details.

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