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To maintain a nasal airway while providing septal support following surgery.

The Nasal Airway Splint is designed provide septal support and allow nasal breathing post-operatively through the integral airway. The splints can be sutured through the preformed holes in the anterior tips for stabilization. The Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.

The provided text is a 510(k) premarket notification for a medical device (Nasal Airway Splint). It describes the device, its intended use, and states that it has been determined substantially equivalent to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot populate the table or answer the specific questions about device performance and validation studies. The document states "Testing: Device is constructed using well-established medical grade silicone," which implies material testing but not performance in a clinical or simulated clinical setting against specific acceptance criteria.

Based on the provided text, none of the requested information regarding acceptance criteria and the study proving the device meets them is available.

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