(72 days)
The intended use is as a wound dressing layer for skin graft recipient sites, newly sutured wounds, abrasions, lacerations and minor or partial thickness burns. These dressings may also be used as an initial layer for wounds with light exudates where deodorization is desired.
These dressings are intended for use as a primary layer for donor sites, skin graft recipient sites and minor burus. These dressings may also be used as an initial layer for surgical incision sites and as a seal around tubes and drains exiting the body.
These dressings are intended for use as a primary dressing in the management of light to medium draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the care of a health care professional for heavy draining wounds such as surgical incisions, skin grafts and dermal ulcers.
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I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for several wound dressings (Medline Curad Oil Emulsion Dressing, Medline Curad Xeroform Petrolatum Dressing, and Medline Curad Petrolatum Gauze Dressing).
This document does not contain any information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any details related to AI, algorithms, or ground truth establishment. The letter is purely an administrative notification of the substantial equivalence determination for the medical devices listed, based on their intended use.
Therefore, I cannot extract the information requested in your prompt from this document.
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