(70 days)
lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.
lamin® Impregnated Gauze Dressing acts to provide a moist wound environment and protect the wound. lamin® Impregnated Gauze Dressing was designed to provide a soothing, moist environment for each application to various types of wounds as an impregnated gauze dressing. lamin® Impregnated Gauze Dressing is sterile impregnated cotton-blend non-woven gauze.
The provided text describes a medical device called "lamin® Impregnated Gauze Dressing" and its substantial equivalence to predicate devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested in your prompt regarding AI/machine learning device performance.
This document describes a traditional medical device (a wound dressing) and its regulatory submission, which relies on demonstrating substantial equivalence to already-marketed predicate devices, primarily through biocompatibility testing. It is not an AI/ML powered device, and therefore the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, MRMC studies, etc.) are not applicable here.
Therefore, I cannot populate the table or answer the specific questions as the input text does not contain the relevant information for an AI/ML device.
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