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Intermittent drainage of the urinary bladder of Adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.

The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).

GC Air for Men is a sterile, single use, disposable, hydrophilic, intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). The catheter tube is made using thermoplastic elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction.

The provided document describes the Convatec GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a medical device (a urinary catheter), not an AI/ML diagnostic or predictive system. Therefore, the typical acceptance criteria and study designs relevant to AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, ground truth establishment by experts) are not applicable or present in this document.

The "Performance Testing" section on page 5 refers to standard testing for physical medical devices and their materials, sterilization, and packaging, not clinical performance metrics related to AI/ML.

Therefore, an answer formatted as requested cannot be provided from this document.

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