(152 days)
Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of partial and full thickness wounds 15 and 200 degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.
AQUANOVA Ag Super-Absorbent Dressing (Silver containing Antibacterial Dressing) is a soft, sterile, nonwoven pad or ribbon dressing is composed of Chitosan derivative materials with the addition of ionic silver ions. The ionic silver ions present in the dressing help to inhibit bacterial growth in the dressing. The dressing absorbs wound fluid and exudate and creates a soft, cohesive gel that intimately conforms to the wound bed and creates a moist wound healing environment conducive to wound healing and aids in the removal of non-viable tissue from the wound (autolytic debridement).
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance as requested in your prompt. The document is a 510(k) summary for a medical device (AQUANOVA Ag Super-Absorbent Dressing), which focuses on establishing substantial equivalence to predicate devices rather than reporting study results against specific performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert involvement, or comparative effectiveness studies based on this document.
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