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The Collagran wound dressing and Collagran Ag wound dressing are intended to be used for the following conditions: the management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, first and second degree burns, donor and graft sites, abrasions and lacerations, dehisced surgical wounds, traumatic wounds healing by secondary intention

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The provided text is a 510(k) premarket notification approval letter for the "Collagran wound dressing" and "Collagran Ag wound dressing." This type of document does not typically contain details about specific acceptance criteria or a study proving that a device meets those criteria in the way a clinical trial report or a performance study summary would.

The letter focuses on the FDA's determination of "substantial equivalence" to a legally marketed predicate device, allowing the devices to be marketed. It lists the intended indications for use (types of wounds the dressing can manage) but does not provide performance metrics or studies proving efficacy/safety beyond saying it is substantially equivalent to existing devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from this document. This kind of information would typically be found in the 510(k) submission itself, a clinical study report, or a summary of safety and effectiveness, none of which are present here.

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