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

The Female IC (not finalized) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Female IC is inserted into the urethra to drain urine from the bladder. This directly hydrated catheter is packaged in a polypropylene/polyethylene case which was designed to be easy to open, close and dispose of, with a discrete consumer design. A "first use label" on the case indicates to the end user if the product was previously opened.

The provided document is a 510(k) summary for a medical device (Female IC intermittent catheter) and primarily discusses its substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It does not include information about AI/ML algorithm performance, clinical studies involving human readers, or specific performance metrics like sensitivity, specificity, and AUC that would be expected for an AI/ML medical device.

Therefore, I cannot fulfill the request for information related to acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional medical device (catheter) and its regulatory clearance process based on substantial equivalence, not AI/ML performance.

If you have a document describing an AI/ML medical device, please provide that, and I will be happy to extract the requested information.

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