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To facilitate the placement of devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.

The products identified in this 510(k) notification are splittable, polyethylene introducer catheters. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate springactivated needle-shielding technology. The Autoguard component incorporates a cylindrical needle-shielding barrel, a spring, a needle hub with flash chamber and hydrophobic flow control plug, and a needle. The useractivated Autoguard™ product has a button, which the user pushes to initiate the needle's retraction into the needle-shielding barrel.

The Introsyte introducers are available in sizes ranging from 14 to 24 gauge.

The provided text is a 510(k) summary for a medical device (introducer catheters) and a letter from the FDA. It does not describe any AI device, acceptance criteria or a study proving that an AI device meets acceptance criteria.

The document discusses BD Introsyte™ Precision Introducer and BD Introsyte™ Autoguard™ Shielded Introducer, which are physical medical devices. The "Nonclinical Tests Support Substantial Equivalence" section states: "Side-by-side testing of modified and unmodified devices was conducted to compare product attributes. Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices." This refers to physical and biocompatibility testing of traditional medical devices, not AI performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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