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The TT101 Wound Care Dressing is indicated for the management of exuding wounds including: Diabetic ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds

TT101 Wound Care Dressing is a sterile primary dressing comprised of phosphorylated cellulose, formed into a sheet approximately 3 mm thick cut into various size pieces. When placed on a wound, the dressing provides a moist wound environment that is supportive to wound healing.

The provided text does not include information about acceptance criteria, device performance metrics, or any study details that would typically be associated with proving a device meets acceptance criteria. The text is a 510(k) summary and regulatory letter for a wound dressing, focusing on its substantial equivalence to a predicate device and its intended use.

Therefore, I cannot populate the requested table or answer the specific questions about study design, sample sizes, ground truth, or expert involvement. The document primarily addresses regulatory clearance for a physical medical device (wound dressing) based on substantial equivalence, not performance metrics derived from a study to establish acceptance criteria.

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