(84 days)
Cutimed® Sorbact® Hydroactive is indicated for use in the management of low to moderate exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds,
Cutimed® Sorbact® Hydroactive B is indicated for use in the management of low to moderate exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds (yenous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Cutimed® Siltec Sorbact® is indicated for use in the management of moderate to heavily exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ucers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Cutimed® Sorbact® Wound Dressings combine Sorbact mesh (Sorbact acetate fabric coated with dialkylcarbamoylchloride - DACC) with a highly absorbent hydropolymer matrix or superabsorbent polyurethane foam and are covered by a semi-permeable polyurethane film. A fixation border is made of a latex free hydrogel or silicone adhesive. The dressings come in three models (Cutimed® Sorbact® Hydroactive, Cutimed® Sorbact® Hydroactive B, Cutimed® Siltec Sorbact®), multiple sizes in each model and are sterile and single use.
The provided text describes a 510(k) premarket notification for a medical device (Cutimed® Sorbact® Wound Dressings) and does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML algorithm.
The document is a letter from the FDA regarding a substantial equivalence determination for a wound dressing, comparing it to a previously marketed predicate device. The information details the device's intended use, design, materials, and testing conducted to demonstrate its functional performance and safety (e.g., absorption, biocompatibility, sterilization, stability).
Therefore, I cannot extract the requested information, as it is not present in the provided text. The questions posed relate to the evaluation of an AI/ML device, which is not what this document addresses.
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