(63 days)
Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.
This device, made of medical grade silicone and titanium dioxide as a colorant under current good manufacturing practices, is a small, generally "plug" shaped design.
The provided text is a 510(k) summary for a medical device called the "Odyssey Punctal Occluder." This document is for regulatory submission and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods.
Therefore, I cannot provide the requested information based on the input document. The document describes the device, its intended use, and argues for its substantial equivalence to a pre-amendment device, but it does not detail any performance studies that would typically include acceptance criteria or the other study-related metrics you've asked for.
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