Search Results

NovoSorb® Matrix is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, partial thickness burns, and skin tears) and draining wounds.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letters for the NovoSorb® Matrix does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letters primarily address the administrative aspects of the 510(k) submission, confirming the device's substantial equivalence to a legally marketed predicate device and detailing regulatory guidelines for its marketing. They do not include details about:

• A table of acceptance criteria or reported device performance metrics.
• Sample sizes, data provenance, or details about test and training sets.
• Information on expert panels, ground truth establishment, or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for this information based on the provided document. The 510(k) clearance process focuses on substantial equivalence, which often relies on comparison to existing devices rather than new performance studies demonstrating specific numerical acceptance criteria in the way described for an AI/ML medical device.

Ask a specific question about this device