(106 days)
The Ryder Lacrimal Intubation set is valuable in the reconstruction of the lacrimal outflow system and also useful in canaliculus repair, lacrimal obstruction and complicated and uncomplicated dacryocystorhinostomy procedures.
The Lacrimal Intubation Set consists of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible silicone tube of varying thickness. The intubation set is a single-use product, sterilized by gamma radiation.
The provided text is a summary of safety and effectiveness for a medical device (Ryder Lacrimal Intubation Set) and a subsequent correction letter from the FDA. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it detail any performance data, sample sizes, expert involvement, or ground truth methodologies typically associated with clinical studies or AI/algorithm performance evaluations.
The document explicitly states: "Based on the 510(k) "Substantial Equivalence" decision-making process and the information provided herein, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act." This indicates that the device was approved based on its similarity to a previously approved predicate device, not through a study demonstrating it meets specific performance acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them from the provided text.
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