(62 days)
Elta Silver Antimicrobial Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Not Found
This document is a letter from the FDA regarding the 510(k) premarket notification for the "Elta Silver Antimicrobial Wound Gel". It states that the device is substantially equivalent to legally marketed predicate devices.
The information you are asking for, regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, and comparative effectiveness studies, is typically found in the premarket notification submission itself, which is a much more detailed document than this FDA clearance letter. This letter is simply the FDA's decision based on their review of that submission.
Therefore, this document does not contain the information requested in your prompt. It does not describe acceptance criteria, device performance, details of studies, sample sizes, or ground truth methodologies. It only states that the device has been found substantially equivalent for the indicated uses.
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