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This device is indicated for use for the treatment of pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds (abrasions, lacerations, second degree burns) and draining wounds.

The patented Abrams Multi-Density Polyurethane Foam Wound Dressing System is a single-patient use sterile medical device that contains silver based anti-microbial agent, effective as antibacterial barrier in the dressing. The dressing is available in different configurations: 4x4" and 4x8" sizes with adhesive backing, sterile; 4x4" and 4x8" sizes without adhesive backing, sterile; 4x11" size without adhesive backing, sterile, attached to 11x38" cotton bandage.

The provided document, K033164, is a 510(k) summary for a wound dressing system. It does not contain any information about acceptance criteria or a study that proves the device meets such criteria related to AI or algorithm performance.

Instead, this document describes a traditional medical device (wound dressing) and its substantial equivalence to previously cleared predicate devices. The safety and effectiveness are established through comparison to these existing devices, not through performance metrics of an algorithm or AI.

Therefore, I cannot provide the requested information. The document focuses on material composition, intended use, and comparison to similar commercially available dressings.

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