(152 days)
The EagleVision Gellansert is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:
- Determine the potential effectiveness of permanent occlusion,
- Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
- Increase retention of ocular medications
- Temporarily treat contact lens intolerance secondary to dry eye, and
- Treat dry eye after surgery.
EagleVision Gellanserts are intended to temporarily block tear drainage by occlusion of the canaliculus. EagleVision Gellanserts are made of a hydrophilic, resorbable material, and are designed to expand only laterally after insertion into the canaliculus, so that only one size is needed to occlude most patients' lacrimal systems. The EagleVision Gellanserts are designed to expand and fit virtually all patient anatomies from 0.3mm up to 1.1 mm, so multiple inserts in one canaliculus are generally not necessary. There are five inserts per sterile pouch, so that one EagleVision Gellansert can be placed in each punctum with one additional EagleVision Gellansert in case one is dropped or mishandled.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (EagleVision Gellanserts), which focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and study results against those criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information regarding sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
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