(224 days)
The exsalt™ Wound Dressing is indicated for first aid to help minor cuts, scrapes, abrasion, lacerations and scalds.
The exsalt™ Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. Exciton Technologies Inc. has developed exsalt™ technology; a proprietary chemical process, which deposits oxidized silver species onto the non-woven polvester coated with Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressit™ Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis.
The provided text describes the "exsalt™ Wound Dressing" and its 510(k) submission. It details performance tests conducted but does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device. This document concerns a physical wound dressing, not an AI/ML device.
Therefore, I cannot fulfill the request as it asks for information pertinent to AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) which are not applicable to the provided document about a wound dressing.
The document discusses various performance tests for the physical wound dressing, such as Absorptive Capacity, Moisture Content, Drop Penetration, Adhesion, Abrasion, Silver Content, Anti-microbial (bacterial) Effectiveness, Bactericidal Effectiveness, Biocompatibility, and Biological Reactivity. It states that these characteristics were found to be substantially equivalent to a predicate device and that the dressing showed no new safety concerns. However, it does not present these as specific numerical "acceptance criteria" alongside "reported device performance" in a table as requested for an AI/ML context.
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