(203 days)
Silcryst® Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds.
Silcryst® Silver Antimicrobial Wound Cream is a non-sterile, semi-viscous emulsion intended for topical application for external wound management. It aids the body by providing a moist wound environment optimal for healing. The cream also serves as a broad spectrum anti-microbial barrier. It is presented as a prescription product.
This document is a 510(k) summary for Silcryst™ Silver Antimicrobial Wound Cream. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria, particularly in the context of an AI/ML device.
The 510(k) summary states:
- "Functional and performance testing has been conducted to assess the safety and efficacy of Silver Antimicrobial Wound Cream and results are satisfactory." This is a high-level statement and does not provide specifics on the tests performed, the acceptance criteria, or the results in a quantifiable manner.
Therefore, I cannot provide the requested information in the table format because the details about acceptance criteria and device performance as expected for an AI/ML device study (e.g., sensitivity, specificity, accuracy) are not present in this regulatory document. The document primarily focuses on establishing substantial equivalence to existing predicate devices based on intended use and technological characteristics for a wound cream, not an AI/ML-driven diagnostic or treatment device.
If this were an AI/ML device, the detailed information requested about sample sizes, data provenance, ground truth establishment, expert qualifications, and MRMC studies would be crucial and would typically be included in a more comprehensive study report or a different section of the 510(k) submission.
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