(68 days)
AcryDerm Silver Antimicrobial Perforated Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce 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 Perforated Dressing is a line extension of the previously cleared product, AcryDerm Silver Antimicrobial Strands. The new product is made from the same matrix material, has the same composition and is made using substantially an equivalent manufacturing process as the predicate. The new product is an absorbent, perforated wound dressing that contains antimicrobial silver that minimizes the growth of microbial contaminants in contact with the dressing. AcryDerm Silver Antimicrobial Perforated Dressing will be supplied sterile packaged in single use heat sealed medical grade poly-laminate pouches. The single use primaries will be packed into dispenser boxes for distribution. Biocompatibility has been assessed and it meets the requirements of ISO 10993-1 (Biological Evaluation of Medical Devices).
This document is a 510(k) summary for a medical device called "AcryDerm Silver Antimicrobial Perforated Dressing." It describes the device, its intended use, and its substantial equivalence to a previously cleared product. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria.
This type of submission to the FDA focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device). This typically involves showing that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text only addresses the comparison of the new device to a predicate device, focusing on its composition, manufacturing process, and intended use to establish substantial equivalence. It is not a clinical study report or a performance validation document in the context of specific quantitative acceptance criteria.
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