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This intermittent catheter is a flexible tubular device that is inserted through the urethra by female patients who need to drain urine from the bladder.

The Infyna Chic is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. Infyna Chic has the following features:

• Hydrophilic-coated PVC catheter (phthalate free)
• Two smooth catheter eyelets
• Color-coded funnel
  The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The primary packaging is designed to be easy to open, close and dispose of, with a discrete consumer design. The outer packaging also contains a 'first use label' that indicates to the end user if the product was previously opened.

This document is a 510(k) premarket notification for a medical device, specifically an intermittent catheter called "Infyna Chic." It's not a study proving the device meets acceptance criteria for an AI/ML product, but rather a regulatory submission demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance testing.

Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device is not present in this document. The document details the device's physical and material properties, sterilization methods, and packaging integrity tests, along with a comparison to a predicate device.

To directly answer your prompt, based only on the provided text, the answer is that this document does not contain the information you requested about AI/ML device performance and testing. It's for a traditional medical device (catheter).

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