(263 days)
Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.
Granudacyn® Wound Wash Solution is composed of water (H2O), hypochlorous acid (HOCl), sodium hypochlorite (NaOCl) and sodium chloride (NaCl). Pure water and pure sodium chloride are subjected to an electrolysis process to create the final solution.
The provided FDA 510(k) clearance letter for Granudacyn® Wound Irrigation Solution (K243415) does not contain information about acceptance criteria or a study that uses a device to meet acceptance criteria in the context of AI/ML or diagnostic performance.
This document pertains to a medical device that is a wound wash solution, not an AI-powered diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device (Vashe® Wound Solution) through non-clinical testing of its physical and chemical properties and general effectiveness as a wound care product.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of device and regulatory submission presented.
The "Clinical Data Summary – Subject Device" section explicitly states: "Clinical Testing: Clinical data is not required." and "No clinical data was required to support substantial equivalence." This further confirms that no studies proving diagnostic accuracy or clinical effectiveness in a human cohort were conducted or needed for this clearance.
In summary, the provided text does not contain the information required to answer your specific questions related to AI/ML device performance and acceptance criteria.
N/A