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Advanced Medical Solutions Ltd's Silver Foam Wound Dressings are indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers; leg ulcers; diabetic foot ulcers; graft wounds and donor sites; skin tears; first and second-degree burns; surgical wounds; lacerations and abrasions.

(Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings are sterile, extremely absorbent, conformable, and semi-permeable to moisture vapour, and assist in maintaining a moist environment for optimal wound healing. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings contain nominally 1% ionic silver (silver sodium hydrogen zirconium phosphate); the action of which protects the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration. The antimicrobial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against bacterial and fungal strains known to be detrimental to wound healing, such as; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Streptococcus pyogenes, Staphylococcus epidermidis, MRSA (Methicillin resistant Staphylococcus aureus) MRSE (Methicillin resistant Staphylococcus epidermidis), and VRE (Vancomycin resistant Enterococcus faecium). The antibacterial effect in the (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings supports the reduction of odour caused by microorganisms absorbed in wound exudate. (Brand name*) Silver Foam Adhesive and Non-Adhesive Wound Dressings may be used with a compression bandage.

This is a 510(k) premarket notification for a medical device (wound dressing), not a study describing AI software. Therefore, the requested information about acceptance criteria, study design, and AI performance metrics is not applicable and cannot be extracted from the provided text.

Specifically:

• No AI component: The device described is a physical wound dressing containing silver, not an AI software or system.
• No clinical study to prove acceptance criteria for AI: The document is a regulatory submission demonstrating substantial equivalence to a predicate device, primarily through comparison of physical characteristics, intended use, and existing in-vitro antimicrobial testing, not a clinical trial evaluating advanced performance metrics for AI.
• No "acceptance criteria" in the context of AI performance: The "acceptance criteria" here refer to regulatory requirements for demonstrating safety and effectiveness of a physical medical device, not performance benchmarks for an AI algorithm.

Therefore, I cannot provide the requested table and information as it pertains to AI performance.

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