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The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder.

The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder. The hydrophilic coating will allow the stent to become 'slippery-when-wet' which will reduce friction. This device will be made from polyurethane, silicone and a hydrophilic coating.

Due to the nature of the provided text, which is an excerpt from a 510(k) Premarket Notification for a medical device (AQ Hydrophilic Stent), it does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment.

The provided text focuses on:

• Submission details: Applicant, date, device name, classification.
• Predicate devices: Stating equivalence to existing devices.
• Device description: Intended use, materials, "slippery-when-wet" property due to hydrophilic coating.
• Substantial Equivalence claim: Based on indications for use, materials, physical construction, manufacturing controls, packaging, and sterilization.

This type of document for a Class II medical device (like a ureteral stent) typically relies heavily on predicate device comparison and bench testing for performance, biocompatibility, and sterilization validation, rather than large-scale clinical studies with acceptance criteria based on metrics like sensitivity, specificity, or reader performance, as would be common for AI/ML-based diagnostic devices.

Therefore, I cannot populate the table or answer the specific questions based on the provided input. The information simply isn't present in this excerpt.

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