(166 days)
AcryDerm Silver Antimicrobial Foam Wound Dressing is indicated for the management of 1st and 2nd degree burns, wounds such as venous and arterial ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
AcryDerm Silver Antimicrobial Foam Wound Dressings are sterile, single use hydrophilic polyurethane foam dressings containing antimicrobial silver for use in the management of wounds.
This 510(k) summary for the AcryDerm Silver Antimicrobial Foam Wound Dressing does not describe a study involving device performance metrics, acceptance criteria, or ground truth relevant to AI/ML or diagnostic devices.
The document states:
- "Testing: the new product meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ANSI/AAMI/ISO standard (10993-1:2003 - Biological Evaluation of Medical Devices - Part I: Evaluation and Testing)"
- "Performance Standards: No performance standards are prescribed for the new product."
This indicates that the submission focuses on safety and biocompatibility testing against established standards for wound dressings, rather than a performance study measuring sensitivity, specificity, accuracy, or similar metrics typically associated with AI/ML diagnostic devices. There is no mention of a "test set" in the context of diagnostic performance, nor are there any reported performance values like sensitivity or specificity.
Therefore, I cannot fill in the requested information as it pertains to a different type of device evaluation, one that is not present in this 510(k) document.
N/A