(187 days)
Abrasions and lacerations, dermal wounds, donor sites, first- and second-degree burns, surgical incisions, vascular access sites, pressure ulcers stages I-IV, stasis ulcers, venous ulcers.
Algidex Ag® silver alginate wound dressings are an antimicrobial barrier for up to three (3) days. The dressings utilize a formulation of ionic silver combined in an alginate and maltodextrin matrix. The silver is intended to prevent microbes from passing through the dressing during use. The dressings are offered in two configurations:
- a paste;
- a paste applied to a non-adherent polyurethane foam layers in various sizes and shapes;
The device is sterilized by gamma irradiation.
The provided document is a 510(k) premarket notification for a medical device (wound dressing) and DOES NOT contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
This document describes a traditional 510(k) for a physical medical device, the "Algidex Ag Silver Alginate Wound Dressing." The submission focuses on demonstrating substantial equivalence to predicate devices (SilverSite and Calgitrol Ag) based on technological characteristics and performance tests related to the physical properties and antimicrobial effectiveness of the wound dressing.
The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are highly relevant to AI/ML medical device submissions, where algorithms are evaluated for their diagnostic or predictive performance against established ground truth.
Therefore, I cannot extract the requested information from this document because it is not an AI/ML device submission.
The document discusses "performance tests" for the wound dressing, which are entirely different from the performance evaluation of an AI algorithm. For instance, it mentions:
- AATCC 100 test method: This is a standard test for antibacterial activity of fabrics.
- Antimicrobial barrier testing: Evaluating the dressing's ability to prevent microbial passage.
- Absorbency test: Measuring fluid absorption.
These are not related to AI model performance metrics like sensitivity, specificity, AUC, human reader improvement, or ground truth established by expert consensus on imaging data.
N/A