(329 days)
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP). This product maintains a moist wound environment that supports the healing process by encouraging autolytic debridement and allowing granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination, and absorbs exudate from the wound. It is indicated for use on dry, light and moderately exuding partial and full thickness wounds such as: First and second degree burns, superficial injuries, lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears. Medline TenderWet™ should be used under direction of a health care professional for Stage I-IV Pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology. Medline TenderWet™ may be used to condition wound sites prior to skin transplants.
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP).
This document is a 510(k) clearance letter from the FDA for a wound dressing, not a study describing the acceptance criteria or performance of an AI-powered device. Therefore, I cannot extract the requested information about acceptance criteria or a study proving a device meets them from this text.
The document pertains to the Medline TenderWet™ Wound Dressing and primarily states that the FDA has found it to be "substantially equivalent" to legally marketed predicate devices, allowing its commercialization. There is no mention of AI, acceptance criteria beyond substantial equivalence, or a study detailing performance metrics for meeting specific criteria.
N/A