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Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated

A flexible silicone ophthalmic device designed to fit and be retained in the punctum.

The provided document is a 510(k) Notification Summary for the Herrick Ultimate Punctum Plug. It does not contain information about acceptance criteria or specific studies proving device performance beyond a comparison to predicate devices and a statement that no clinical tests were performed.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document explicitly states "Clinical tests: None" and "Adverse S&E information: None," indicating that no performance studies of the type described in the request were conducted or reported for this submission. The basis for clearance appears to be substantial equivalence to predicate devices based on indications, function, design (dimensions), and material.

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Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated.

A flexible silicone ophthalmic device designed to fit and be retained in the punctum.

K963708, a 510(k) premarket notification for the Herrick Ultimate Punctum Plug, does not contain information related to acceptance criteria or studies proving the device meets said criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing performance studies and acceptance criteria as a standalone device.

Specifically, the document states "Clinical tests: None" and "Adverse S&E information: None", indicating that no clinical studies were performed or are being presented in this submission. The comparison table focuses on features, indications, function, design (length, diameter), and material between the Herrick Ultimate Punctum Plug and predicate devices to establish substantial equivalence.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device