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510(k) Data Aggregation
(87 days)
SUTUREGROOVE WEIGHT SIZING SET
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(118 days)
SUTUREGROOVE
SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis
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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is primarily a 510(k) clearance letter for the "Suture Groove™ Gold Eyelid Weight Implant," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls, and indications for use.
Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, details on MRMC studies, standalone performance, training set information, or ground truth establishment. This information is typically found in a clinical study report or a premarket submission summary, which is not present in the given text.
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