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AcryDerm Silver Antimicrobial Wound Gel is an amorphous wound moisture management gel that is an effective antimicrobial barrier. The antimicrobial barrier function of the dressing may help reduce the incidence of infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.

AcryDerm Silver Antimicrobial Wound Gel is a line extension of the previously cleared product, AcryDerm Gel Wound Dressing. The new product is a moist amorphous gel wound filler that contains antimicrobial silver that inhibits the growth of microbial contaminants in contact with the dressing. The high moisture content gel contains a base matrix composed of hydrophilic polyacrylate absorbent microspheres that contain a silver complex and stabilizers to prevent discoloration and staining from the dressing. AcryDerm Silver Antimicrobial Wound Gel will be supplied in collapsible blind ended heat sealed co-laminate foil tubes fitted with screw caps. The reusable product primaries will be packed in individual dispenser boxes with a product insert. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).

This looks like a 510(k) premarket notification for a medical device called AcryDerm Silver Antimicrobial Wound Gel. However, the provided text does not contain information about a study with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness as typically associated with clinical performance studies for AI/ML devices.

The document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a performance study report for a novel AI algorithm. Therefore, I cannot extract the requested information like acceptance criteria, study findings, sample sizes for test/training sets, or details about expert adjudication from this specific text.

Here's why the information is not present in the provided text:

• Device Type: This is a wound dressing with antimicrobial properties, not an AI/ML diagnostic or prognostic device. The regulatory submission focuses on its physical characteristics, intended use, and comparison to existing wound dressings.
• Regulatory Pathway: A 510(k) is a premarket notification that demonstrates substantial equivalence to a predicate device. It typically relies on comparisons of technological characteristics and intended use, and sometimes bench testing or minor clinical data to support safety and effectiveness, but not necessarily a large-scale clinical performance study with sophisticated statistical analysis as would be required for an AI device.
• Absence of AI/ML Specifics: There is no mention of algorithms, machine learning, image analysis, diagnostic performance metrics (like sensitivity, specificity, AUC), or human-in-the-loop studies.

In summary, the provided document is not a study report that would contain the information you've requested about acceptance criteria and device performance in the context of an AI/ML device.

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