(261 days)
The following conditions are considered appropriate for OTC use by the lay person: Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations.
The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider: Coreleader AlgiPlaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds.
Coreleader AlgiPlaster is composed of Alginate fiber and combined with the thin polyurethane membrane coated with a layer of an acrylic adhesive. The dressing combination, which is permeable to both water vapor and oxygen, is impermeable to micro-organisms and once in position, it provides an effective barrier to external contamination, and producing a moist environment at the surface of the wound by reducing water vapor loss from the exposed tissue. The moist environment provided by the alginate fibers may provide an environment favorable to the wound healing process. Coreleader AlgiPlaster is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 106 SAL.
The provided text is a 510(k) summary for a wound dressing, the Coreleader AlgiPlaster. It describes the device, its intended use, technological features, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML-based medical devices.
The submission is for a medical device that falls under the "Unclassified" category, meaning it does not require a PMA (Premarket Approval) and is subject to general controls. The review process outlined in the document confirms that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence is based on the device's technological characteristics and intended use being similar to existing cleared devices, rather than on a performance study against specific acceptance criteria for a new clinical claim.
Therefore, I cannot provide the requested table and study details because the provided document does not contain this information. The K102942 submission is not an AI/ML device and thus does not include the typical elements of an AI/ML device submission such as test sets, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.
The document is a traditional 510(k) submission for a wound dressing and focuses on demonstrating substantial equivalence to predicate devices based on physical and functional characteristics, biocompatibility, and intended use.
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