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Scaraid is intended for the management of hypertrophic and keloid scars and it is not intended to be used on open wounds.

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This document is a 510(k) clearance letter from the FDA for a device called "ScarAid Silicone Gel Sheeting". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document addressing the substantial equivalence of the device to a predicate device already on the market.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is deemed "substantially equivalent" for the management of hypertrophic and keloid scars but does not detail performance metrics, study designs, or ground truth establishment.

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Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.

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I'm sorry, but the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a device called "Epi-Foam Silicone Sheeting," indicating that it is substantially equivalent to a pre-existing device for the management of hypertrophic and keloid scars.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study, sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

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Ask a specific question about this device