(199 days)
The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
X-Static® SILVERSEAL™ Hydrogel Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrogel Wound Dressing consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% silver oxide.
The provided text describes the X-Static® SILVERSEAL™ Hydrogel Wound Dressing, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance.
The "Assessment of Performance Data" section primarily focuses on safety testing (cytotoxicity, sensitization, intracutaneous, and acute reactivity) performed in accordance with ISO 10993 standards. It explicitly states, "All antibiotic claims are the result of In Vitro studies and that the effect of the antibiotic has not been studied in a clinical setting." This means there is no clinical data presented to support performance related to antimicrobial efficacy on actual wounds or other clinical outcomes.
Therefore, I cannot fill out the requested table or answer the questions related to performance criteria, sample sizes for test/training sets, expert involvement, or AI-related metrics because this information is not present in the provided document.
The document discusses:
- Safety Assessments: The device underwent standard tests for cytotoxicity, sensitization, intracutaneous, and acute reactivity as per ISO 10993.
- Antimicrobial Claims Basis: Antimicrobial claims are based solely on in vitro studies, and the effect has not been studied in a clinical setting.
Without further information describing performance criteria and a study that assesses the device against those criteria (beyond basic safety), a complete answer to your request cannot be generated from the given text.
N/A