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The Tula Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Grommet type tympanostomy tube.

The Tula Tube Delivery System (TDS) is a device that penetrates the tympanic membrane and inserts the Grommet type tympanostomy tube with a button controlled activation. It is intended to provide a means to create a myringotomy with insertion of a preloaded grommet type tympanostomy tube.

This document describes the TULA Tube Delivery System, a medical device intended to create a myringotomy and insert a tympanostomy tube. The document is primarily a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to a predicate device. As such, it does not contain information related to software performance, AI algorithms, or clinical study results with acceptance criteria typical for AI/ML devices.

The provided text focuses on the device's mechanical functions, sterilization, and biocompatibility, which are assessed through bench verification testing. Therefore, I cannot generate the requested table and information about acceptance criteria, study design, and AI performance from the given text.

The information provided pertains to the regulatory clearance of a physical medical device, not a diagnostic AI system.

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