(95 days)
The SiOxD Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and fullthickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first degree and partial thickness burns, skin tears) and draining wounds.
The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body's natural healing process.
The SiOxD Wound Matrix is not designed to be held in place with compression bandages or tapes. Only light pressure without mechanical compression or secondary bandaging is required for proper device function. The matrix applied to the wound bed naturally sloughs off during wound healing and does not require manual removal.
The provided document K232847, a 510(k) summary for the SiOxD Wound Matrix, does not contain information on an AI/ML-based medical device. Therefore, it does not include details on acceptance criteria, study methodologies for AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document describes a medical device, the SiOxD Wound Matrix, which is a non-pyrogenic, sterile, single-use wound dressing made from hydrated amorphous silica in fibrous form. The submission is for a line extension of an already cleared device (K222189). The new submission adds new intermediate size offerings and single barrier packaging configurations.
Since this is a submission for a physical medical device (wound dressing) and not a software/AI device, the information requested in your prompt regarding AI/ML performance, acceptance criteria, and specific study details (like sample size for test/training sets, expert ground truth) is not applicable to this document. The "study that proves the device meets the acceptance criteria" in this context refers to standard medical device testing (e.g., sterilization, packaging integrity, biocompatibility), not AI model validation.
If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.
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