(202 days)
The Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
The Axiostat Patch is a sterile, single use, non-absorbable hemostatic dressing. It is composed of chitosan a well-known natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted. The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation.
The provided text describes the Axiostat Patch, a hemostatic dressing, and outlines the non-clinical studies performed to demonstrate its safety and performance for its intended use. However, it does not contain information related to acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI-powered medical device.
The document details the following types of studies for a physical medical device (hemostatic patch):
- Biocompatibility testing: Performed according to ISO 10993-1:2009 for surface devices, including tests for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and bacterial endotoxin.
- Heavy metal testing: To ensure the finished, sterilized product met USP-232 limits.
- Bench performance testing: Including appearance, moisture content, absorbency, pH, integrity, tensile strength, and in vitro blood clotting.
- Barrier to bacteria testing: Evaluated the patch's ability to act as a barrier against gram-positive and gram-negative bacteria.
- Animal studies: Evaluated hemostasis in a vascular injury wound model in swine.
- Sterilization and packaging validation: Including seal strength, dye penetration, sterility, bacterial endotoxin, and bench performance tests to validate a 5-year shelf life.
Since the provided text does not describe an AI medical device or its performance criteria, I am unable to answer most of your specific questions related to AI device acceptance criteria, sample sizes for test/training sets, expert involvement in ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, I cannot populate the table or provide details for points 2-9 as the provided document does not contain this information for an AI device.
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