Search Results

The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the silver component present in the dressing may act as a barrier to colonization of E coll, S aureus, A. niger, C. albicans, and P. aeruginosa within the dressing.

The Arthrex ProWick™ device is a post-surgical antimicrobial wound dressing containing a variety of elements such as elastic straps, waterproof bandages, dressing, foam islands infused with a silver based antimicrobial agent, and a reusable cold pack, sold sterile.

The provided text is a 510(k) summary for the Arthrex ProWick™ wound dressing. This document establishes substantial equivalence to predicate devices, but it does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The summary describes the device, its indications for use, and states that technical characteristics are similar to predicate devices or that differences do not raise safety/effectiveness concerns. It also mentions that materials are well-characterized and used in predicate devices.

Therefore, the requested information regarding acceptance criteria and performance studies cannot be extracted from this document. The document is primarily a regulatory filing to demonstrate substantial equivalence, not a detailed report of a performance study.

Ask a specific question about this device