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The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® is intended to block the canaliculus for the relief of dry eye syndrome.

Dissolvable Opaque Herrick Lacrimal Plug® may be used:

• As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-dissolvable plugs.
• To temporarily enhance the efficacy of topical medications or ocular lubricants.
• After ocular surgery to prevent complications due to dry eyes.
• To evaluate treatment of ocular dryness secondary to contact lens use.
• In the treatment of Dry Eye Syndrome and the dry eye components of varying Ocular Surface Diseases.

The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® provides temporary occlusion of the tear drainage system. The plug is supplied in various sizes ranging from 0.2 mm to 0.5mm in diameter. The length is approximately 1.75 mm. The dissolvable (suture material) plug is composed of any one of the following: (1) a copolymer of L-lactide and epsilon -caprolactone (PCL); (2) polydioxanone (PDO); (3) copolymers of glycolic acid and trimethylene carbonate.

The proposed device is supplied as a single use component for use in treatment of dry eye syndrome. The device is supplied sterile and is intended for SINGLE USE ONLY.

The provided text describes a Summary of Safety and Effectiveness for the Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® device and a 510(k) clearance letter. It does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices already on the market, which is the basis for 510(k) clearance. This means the new device shares similar technological characteristics and intended uses with a legally marketed device.

Therefore, many of the requested categories for a study's acceptance criteria and performance cannot be directly extracted from this document, as a formal performance study with these elements is not presented.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The "performance" described is in terms of its intended use and compliance with manufacturing standards, assuming equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical study with a test set of subjects/patients to evaluate performance. The 510(k) clearance is primarily based on a comparison of technological characteristics and intended use to predicate devices, not on new clinical trial data that would require a "test set" in the context of device performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert-established ground truth is described in the provided documents for device performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool or an imaging device, so an MRMC study is irrelevant to its premarket notification.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (lacrimal plug), not an algorithm or software requiring standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no performance study described that would involve establishing a "ground truth" for diagnostic accuracy or similar metrics. The "ground truth" for 510(k) substantial equivalence relies on regulatory compliance and the established safety and effectiveness of predicate devices.

8. The sample size for the training set

Not applicable. No training set is described as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

Not applicable. No training set is described.

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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).

Not Found

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.

Ask a specific question about this device