(132 days)
Non-Adherent Antimicrobial Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.
Non-Adherent Antimicrobial Wound Dressing is indicated for external use only.
Non-Adherent Antimicrobial Alginate Dressing is a sterile, non woven pad composed of a high G (guluronic acid) alginate, carboxymethy)cellulose (CMC) and silver coated nylon fibres, laminated to a perforated, non-adherent ethylene methyl acrylate (EMA) wound contact layer. The dressing absorbs exudate and allows intact removal, whilst maintaining a moist wound environment. A moist wound environment is optimal for wound healing. The silver ions within the dressing protects the dressing from bacterial contamination. Odor reduction results from the antibacterial effect.
This document is a 510(k) premarket notification for a medical device modification, specifically for Advanced Medical Solutions Limited's Non-Adherent Antimicrobial Alginate Dressing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for de novo acceptance criteria for a new AI/software device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI or software performance.
Here's why and what information is available:
- Device Type: The device is a wound dressing, a physical medical product, not an AI or software device.
- Purpose of Submission: This is a 510(k) modification for a PHYSICAL device (adding a perforated, non-adherent wound contact layer). The primary goal is to show "substantial equivalence" to existing, legally marketed predicate devices, not to establish new performance criteria for a novel AI.
- Study Types Mentioned: The document refers to:
- Biocompatibility testing: In compliance with BS EN ISO 10993-1.
- Sterilization validation: In compliance with ISO 11137 standards.
- Performance testing and antimicrobial activity: Stated to be substantially equivalent to predicate devices.
These are standard tests for physical medical devices and do not involve AI performance metrics, sample sizes for AI test sets, expert ground truth, or MRMC studies.
Based on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and an AI study.
The prompt's specific questions are geared towards the evaluation of AI/software as a medical device (SaMD) or AI-enabled medical devices, which typically involve metrics like sensitivity, specificity, AUC, human reader improvement, and detailed ground truth establishment. This document does not pertain to such a device or evaluation.
N/A