(363 days)
Under the supervision of a healthcare professional, Algicell® Ag dressing is an effective barner to bacterial penetration in moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers/sores (partial and full thickness), donor sites, and traumatic and surgical wounds.
Calcium Alginate Dressing with Antimicrobial Silver
I'm sorry, but this document does not contain the information you requested about acceptance criteria and device performance studies. The document is an FDA 510(k) clearance letter for a medical device (Calcium Alginate Dressing with Antimicrobial Silver) and primarily focuses on the substantial equivalence determination for marketing the device. It outlines regulatory aspects, such as compliance with FDA regulations and an "Indications for Use" statement, but it does not provide details about specific performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.
N/A