(100 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative performance metrics. The primary "acceptance criterion" for 510(k) clearance is Substantial Equivalence to legally marketed predicate devices. | The device provides temporary occlusion of the tear drainage system for its intended uses. It is composed of similar materials as predicate devices. Manufacturing and QC testing are in substantial compliance with current FDA guidelines and 21 CFR 820 regulations. |
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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