(84 days)
The ACell™ Powder Wound Dressing is intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
The ACell™ Powder Wound Dressing is composed of porcine collagen from urinary bladder matrix. It is an absorbent, white to off-white, particulate that is lyophilized and to be used as a topical application. The product is sterile, for single use and is non-pyrogenic.
The provided text is a 510(k) summary for the ACell™ Powder Wound Dressing, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical studies or standalone algorithm performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text because the 510(k) submission for this type of device (a topical wound dressing) typically relies on material composition, device characteristics, and intended use comparison to predicates, along with biocompatibility and sterility data, rather than clinical performance metrics in the way, for example, a diagnostic AI device would.
The document states: "This device, with respect to material composition, device characteristics, and intended use, is substantially equivalent to the predicate devices." This is the core argument of a 510(k) for this kind of device, not a performance study.
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