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The BARD® Vertus™ Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine in adult and pediatric patients of compatible anatomical size. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.

The BARD® Vertus™ Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter used in the drainage of urine. The catheter consists of a shaft with eyelets near the tip, balloon, drainage funnel and inflation arm with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon, once inflated, retains the catheter within the bladder. The shaft has two lumens: one to allow for urine drainage and the second for balloon inflation. The two-way valve, upon activation, permits flow in either direction and allows for inflation and deflation of the balloon. The cap retains the valve and provides identification for the catheter. The catheter will be offered in multiple French sizes to accommodate differing patient anatomies. The product is provided sterile via ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products - ethylene oxide - Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is a single use, prescription-only device.

The provided document does not contain information about an AI/ML medical device and therefore does not describe acceptance criteria or a study proving its performance.

The document is a 510(k) premarket notification for a BARD® Vertus™ Foley Catheter, which is a physical medical device (a urological catheter). The review focuses on its substantial equivalence to a predicate device (BARD® LubriGuard™ Foley Catheter) based on:

• Indications for Use: Both are for drainage, collection, and measurement of urine.
• Technological Characteristics: Both are made of synthetic polyisoprene, hydrogel-coated, and have the same design features (shaft, eyelets, balloon, drainage funnel, inflation arm).
• Performance Data: This primarily involves biocompatibility testing (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity) and non-clinical functional performance testing (e.g., compliance with ASTM F623-99/(R)2013 for Foley Catheters, and coefficient of friction for lubricity).

There is no mention of any AI or machine learning component, nor any study involving human readers, ground truth establishment by experts, or any of the criteria typically associated with AI/ML device performance evaluation as outlined in your prompt's requirements.

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

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