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ABCcolla® Collagen Matrix is intended to be used for management of wounds, including partial and full thickness wounds, venous ulcers, pressure ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor site/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), first and second-degree burns, draining wounds.

ABCcolla® Collagen Matrix is a decellularized porous porcine collagen material which is biocompatible. ABCcolla® Collagen Matrix absorbs exudates, maintains a moist wound environment, and functions to protect the wound. Pre-wetting makes it supple, conforming to the contour of the wound site. ABCcolla® Collagen Matrix is supplied in double peel-open pouches that is terminally sterilized via gamma irradiation.

This is not a medical device that relies on AI/ML. The provided text is a 510(k) premarket notification for a collagen matrix wound dressing (ABCcolla® Collagen Matrix), which is a biological product, not a software or AI-powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable in this context.

The document discusses substantial equivalence to predicate devices based on:

• Performance Data: Biocompatibility studies (ISO 10993), absorbency (EN 13726-1:2002), in vitro degradation, collagen content, and moisture content.
• Animal Data: A wound healing study in animals.

The FDA's review confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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