(25 days)
The SiOxD® Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, 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 is a 510(k) summary for a medical device called the SiOxD® Wound Matrix. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study with defined endpoints.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and the reported device performance: This document focuses on demonstrating equivalence to a predicate device, not on presenting performance metrics against predefined acceptance criteria for the new device.
- Sample sized used for the test set and the data provenance: There is no mention of a clinical test set or data provenance in the context of device performance evaluation. The "material testing" mentioned is likely laboratory-based.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set for ground truth establishment is not described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a wound matrix, not an AI or imaging device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding device performance and testing:
The document explains that the subject device (SiOxD Wound Matrix) is a line extension of an already cleared predicate device (SiOxMed LLC SiOxD Wound Matrix K222189 / K232847). The core of the submission is to demonstrate that the new device does not have significant technological differences from the predicate and performs similarly.
The key change described for the subject device is:
- Allowed use of alternate water raw materials in the manufacture of the device fiber matrix.
To address this change, material testing was performed:
- Material testing of key physical and chemical properties: This testing demonstrated that devices manufactured with any of the qualified water raw materials met "predetermined release criteria."
- Worst-case assessment of endotoxin levels: This assessment showed that devices manufactured with all water raw materials meet the "20 EU/Device acceptance criteria."
In summary, while specific performance acceptance criteria for clinical efficacy are not detailed, the report highlights that the manufacturing change (alternate water raw materials) was validated through laboratory material testing to ensure the device met internal "predetermined release criteria" for physical and chemical properties, and an "acceptance criteria" of 20 EU/Device for endotoxin levels. This is a common approach for demonstrating substantial equivalence for minor manufacturing changes in a 510(k) submission, where extensive new clinical studies are often not required if technological characteristics and intended use remain the same as a predicate.
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