(32 days)
CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including:
- Pressure ulcers
- Venous ulcers
- Vascular ulcers
- Diabetic ulcers
- Trauma wounds (abrasions, lacerations, skin tears)
- First and second degree burns
- Surgical wounds
CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises collagen derived from porcine, which forms a layer of thin film to maintain a moist environment at the wound site.
I am unable to extract acceptance criteria and study details from the provided document. The document is a 510(k) summary for a wound dressing (CollaWound™) and primarily focuses on establishing substantial equivalence to a predicate device, along with biocompatibility testing. It describes the device, its intended use, and states that product characterization and biocompatibility studies confirm its safety and equivalence.
However, the document does not contain information related to specific acceptance criteria, performance metrics, or study designs that would typically be associated with clinical performance studies or algorithm performance evaluations, as implied by your request.
Therefore, I cannot provide the requested table or answer the questions regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies. This type of information is generally found in more detailed clinical study reports or performance testing documentation, which is not present in this 510(k) summary.
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