(306 days)
InnovaMatrix™ is indicated for the management of wounds including; partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, seconddegree burns and skin tears) and draining wounds.
The device is intended for one-time use.
InnovaMatrix™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering.
InnovaMatrix™ is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans.
The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes ranging from 1 x 1cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.
The provided text is a 510(k) summary for the InnovaMatrix™ device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria as would be required for a novel device or a PMA.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a clinical trial for a new diagnostic algorithm or treatment efficacy would. Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a "test set" in the context of an AI/diagnostic algorithm study.
- Information about expert ground truth establishment (number of experts, qualifications, adjudication method).
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
- Standalone performance data for an algorithm.
- Specific "ground truth" types (pathology, outcomes data) for clinical efficacy.
- Training set sample size or how ground truth was established for a training set.
Instead, the study presented in this document is a substantial equivalence demonstration based on:
- Biocompatibility Testing: Evaluating the safety profile of InnovaMatrix™ with various in vitro and in vivo tests (cytotoxicity, skin sensitization, intracutaneous reactivity, acute/subacute/subchronic systemic toxicity, implantation, genotoxicity, material-mediated pyrogenicity). The conclusion drawn is that the biocompatibility profile is comparable to the predicate device.
- Laboratory Testing: Analysis of the physical and chemical properties of the device (cell debris, collagen/elastin/etc. analysis, endotoxin, residual moisture, water absorption, tensile strength, viral inactivation, shelf life, heavy metals). These tests aim to characterize the material and ensure it meets relevant standards.
- Clinical Testing (Human Repeat Insult Patch Testing and Skin Prick Testing): These are safety tests to assess allergic/irritant potential, not efficacy studies.
- Human Repeat Insult Patch Testing: 58 subjects completed, no reactions.
- Skin Prick Testing: 23 subjects completed, 22 showed no reactions, 1 had a low-grade positive reaction that resolved.
Key takeaway: The provided information is about demonstrating the safety and similar technological characteristics of a wound dressing to an existing device, not about proving performance against specific acceptance criteria in a study format typically associated with AI or diagnostic device performance evaluation.
If this were a study proving the device meets acceptance criteria for a diagnostic AI, the structure and content would be vastly different, focusing on metrics like sensitivity, specificity, AUC, human-AI collaboration impact, etc.
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