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K Number
K061398
Device Name
SNUG PLUG PUNCTUM PLUG
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2006-07-11

(53 days)

Product Code
LZU
Regulation Number
N/A
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Ocular dryness. The Snug Plug punctum plug is used to occlude the punctum in the treatment of ocular dryness.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, the information requested about acceptance criteria and the study proving the device meets those criteria is not available. The document is a 510(k) clearance letter from the FDA for the FCI Snug Plug® punctum plug, which primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance information.

The document does not contain:

  • A table of acceptance criteria or reported device performance.
  • Details about a study that would include sample sizes (test set, training set), data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter focuses on regulatory approval based on substantial equivalence, not on the detailed performance characteristics of a new study designed to meet specific acceptance criteria.

N/A