(119 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 is a 510(k) summary for the SiOxD Wound Matrix, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for performance as an AI/ML powered device. Therefore, much of the requested information regarding AI/ML specific studies (MRMC study, standalone performance, ground truth establishment for training/test sets, expert qualifications, adjudication methods, and sample sizes for training/test sets for AI/ML) is not available in this document.
However, I can extract the acceptance criteria and performance related to the device function and biocompatibility as described in the summary:
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional/Material Characterization | ||
| Absorption Capacity | Device to be characterized as absorbent. | Device was characterized as absorbent. |
| Partial Thromboplastin Time (PTT) | Test results to demonstrate material characteristics (no specific threshold stated, but comparison to control is part of the method). | Clotting time was lower than control. |
| Complement Activation | Test results to demonstrate material characteristics (no specific threshold stated, but characterization is needed). | Device was characterized as a complement activator. |
| FTIR Analysis | Results to be consistent with hydrated amorphous silica in fibrous form. | Results were consistent with hydrated amorphous silica in fibrous form. |
| X-Ray Diffraction (XRD) Spectrometry | Results to be consistent with hydrated amorphous silica in fibrous form. | Results were consistent with hydrated amorphous silica in fibrous form. |
| SEM Imaging | Matrix structure to be structurally similar to collagen and create a scaffold for cellular infiltration and vascularization. | The matrix structure was structurally similar to collagen and created a scaffold for cellular infiltration and vascularization. |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic. | Non-cytotoxic. |
| Sensitization | Non-sensitizing. | Non-sensitizing (via ISO 10993-10 and Human Repeat Insult Patch Testing, 100% of subjects showed "No visible skin reaction" in Induction and Challenge Phases). |
| Irritation | Non-irritating. | Non-irritating (via ISO 10993-23 and Human Repeat Insult Patch Testing, 100% of subjects showed "No visible skin reaction" in Induction and Challenge Phases). |
| Acute Systemic Toxicity | Non-toxic. | Non-toxic. |
| Material Mediated Pyrogenicity | Non-pyrogenic. | Non-pyrogenic. |
| Subacute Systemic Toxicity | Non-toxic. | Non-toxic. |
| Implantation (Local Effects) | No adverse tissue response. | No adverse tissue response (via full thickness porcine wound model and subacute toxicity testing endpoints). |
| Endotoxin |
N/A