(44 days)
Rx Indications for Use: Under the supervision of a healthcare professional, Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including 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/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications for Use: OTC Hydrocleanse™ Antimicrobial Skin and Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
The Hydrocleanse Antimicrobial Skin and Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and device irrigation with a pH range of 4.0 - 5.8. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and sprayer.
The provided document is a 510(k) premarket notification for a medical device (Hydrocleanse Antimicrobial Skin and Wound Solution). It primarily discusses the device's substantial equivalence to predicate devices based on intended use, technological characteristics, safety, and effectiveness.
Crucially, this document does NOT describe the "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, specifically regarding performance metrics like sensitivity, specificity, or AUC, a test set, ground truth establishment by experts, or MRMC studies.
Instead, the "Performance Data" section details:
- Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. This ensures the material is safe for biological interaction.
- Bench Testing: This includes physical and chemical property tests (package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC)) and **USP ** testing for preservative effectiveness against specific bacteria (
Proteus mirabilis,Serratia marcescens,Methicillin-Resistant Staphylococcus aureus (MRSA),Vancomycin-resistant Enterococcus faecalis (VRE), andAcinetobacter baumannii).
These tests are standard for a liquid medical device like a wound solution, but they are not related to an AI/ML algorithm's performance.
Therefore, because the document describes a chemical/physical product and not an AI/ML device, the requested information cannot be extracted. I cannot fill in the table or answer the questions related to AI/ML device performance, ground truth, expert opinions, or MRMC studies based on this document.
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