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The Atrion Medical Coated 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.

Indications For Use:

1. Maintenance of lacrimal outflow post primary DCR surgical procedures.
2. Maintenance of lacrimal outflow post failed open DCR surgical procedures with complete obstruction.
3. Reconstruction of the canaliculi.

The Atrion Medical Coated Lacrimal Intubation Set consists of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible coated silicone tube of varying thickness. The intubation set is a single-use product, sterilized by radiation.

This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification summary and a subsequent FDA substantial equivalence letter for a physical medical device: the Atrion Medical Coated Lacrimal Intubation Set.

The document discusses:

• Device Name: Atrion Medical Coated Lacrimal Intubation Set
• Intended Use: Reconstruction of the lacrimal outflow system, canaliculus repair, lacrimal obstruction, and dacryocystorhinostomy procedures.
• Technological Characteristics: The device is similar to a predicate device but has a coating on the tube for increased lubricity and easier insertion.
• Summary of Safety Testing: Biocompatibility testing (cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous toxicity, implantation test, histology) was conducted to demonstrate substantial equivalence to the predicate device.
• FDA Determination: The FDA found the device substantially equivalent to a legally marketed predicate device (Ryder International Lacrimal Intubation Set, K962151) based on the safety testing and intended use.

Since this document pertains to a traditional medical device and not an AI/ML-driven device, the requested information (acceptance criteria, device performance metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or present within the provided text.

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