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AWBAT-S is intended for clean Superfical burn wounds.

AWBAT-D is intended for Donor sites after hemostasis has been established.

AWBAT-M is to be used as protective covering for Meshed autografts.

A Temporary Wound Dressing for coverage of Superficial burns, Donor sites and Meshed autografts until healing occurs. AWBAT is composed of a single or multiple filament knitted nylon fabric, bonded to a thin porous silicone membrane (approx 0.001 inch). The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides.

AWBAT is manufactured in 12"x12" sheets that are cut to sizes of 3"x3", 6"x12" and 12"x12" and ink stamped "AWBAT-S," "AWBAT-D" or "AWBAT-M" accordingly.

AWBAT-S has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-S pore is 0.0036 square inch each.

AWBAT-D has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-D pore is 0.0073 square inch each.

AWBAT-M has pores in the silicone membrane at 1/4" centers and the approximate area of an AWBAT-M pore is 0.0070 square inch each.

AWBAT-S is composed of a 15/2 denier multiple filament nylon knitted fabric, bonded to a thin porous silicone membrane. The nylon side of these components is coated with a non-toxic mixture of porcine collagen peptides (xenogenic component).

AWBAT-D has the same composition as AWBAT-S, except it is more porous to enable the clinician to evacuate a clot through the membrane into an outer sterile wrap.

AWBAT-M has the same composition as AWBAT-D, except the 12/1 denier nylon fabric is monofilament (thinner & less adherent).

This document is a 510(k) Summary for a medical device called AWBAT (AWBAT-S, AWBAT-D, AWBAT-M), which is a temporary wound dressing. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (Biobrane®).

The document does not contain information about acceptance criteria or a study that proves the device meets those criteria. This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text explicitly states "Does the submission include clinical information? No". This confirms that no clinical studies, and thus no stated acceptance criteria or performance data, are present in this 510(k) summary.

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