Search Results

Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.

Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is a sterile nonwoven highly absorbent pad coated with a silver containing soft-adherent lipido-colloid layer on the dressing/wound interface.

In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, which allows for an easy removal of the dressing with little or no damage to healing tissues, leading to no or minor pain.

It is supplied sterile in an individual pouch.

The provided document is a 510(k) premarket notification for a medical device (wound dressing) and outlines its substantial equivalence to a predicate device. It does not describe an AI medical device study with performance criteria and ground truth establishment in the way requested.

The document focuses on demonstrating that the Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is substantially equivalent to a legally marketed predicate device (Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing) based on similar technology, indications, and safety. There is no mention of an algorithm or AI.

Therefore, I cannot extract the information required to fill out the table and answer the questions about AI performance, sample sizes, expert qualifications, or ground truth establishment. This document is about a physical wound dressing, not an AI-driven medical device.

Ask a specific question about this device