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OPAQUE Herrick Lacrimal Plugs may be used in the treatment of:
· Dry Eye symptoms:dryness, redness, itching, burning, intermittont tearing or foreign body sensation.
· For treatment of ocular dryness secondary to contact lens use.
· To enhance the efficacy of topical ocular medications.
· After surgery to provent complications due to Dry Fye.
· For the Dry Eye component of: conjunctivitis, keratitis, corncal ulcer, pterygium blepharitis, red lid margins, recurrent chalazion. corneal erosion, filamentary keratitis and other eye diseases.
OPAQUE Horrick Lacrimal Plugs are indicated by the patient's positive response to The Lacrimal Efficiency Test TM with dissolvable plugs (Lacrimedics).

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The provided document is a 510(k) premarket notification letter from the FDA regarding the "Opaque Herrick Lacrimal Plug®". This type of document declares that a device is substantially equivalent to a predicate device already on the market and does not contain specific acceptance criteria, detailed study designs, or performance data in the way a clinical trial report or a comprehensive device submission would.

Therefore, based solely on the provided text, I cannot extract the information required to answer your request. The document informs Lacrimedics, Inc. that their device is cleared for marketing due to substantial equivalence, but it does not detail the studies or performance data used to determine that equivalence.

The information you are asking for (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in the actual 510(k) submission itself, or in related study reports, which are not included in this FDA clearance letter.

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