(382 days)
An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates and may inhibit the growth of microorganisms within the dressing. Ross Ru Skin Discontinuities is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.
The provided 510(k) summary for "Ross Ru Skin Discontinuities" does not include information about acceptance criteria or a study proving the device meets said criteria, as it is for a wound gel and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a comparison of characteristics.
Therefore, I cannot extract the information required for your request regarding AI/ML device performance, as it is not present in the provided text.
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