(261 days)
ACTICOAT Surgical dressing is indicated for use in light to moderately exuding full and partial thickness wounds including decubitus ulcers, diabetic ulcers, surgical wounds, 1st and 2nd degree burns, and donor sites. ACTICOAT Surgical dressing may be used over debrided and full and partial thickness wounds.
ACTICOAT Surgical is an absorbent trilaminate antibacterial barrier dressing consisting of a silver-coated polyurethane layer, a white polyurethane foam and an adhesive coated waterproof polyurethane film layer. The device provides an effective antibacterial barrier to reduce or inhibit microbial colonization of the dressing.
The provided text describes a 510(k) premarket notification for a medical device (ACTICOAT Surgical Dressing) and includes information about its substantial equivalence to predicate devices, non-clinical tests (bench testing), and biocompatibility testing. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria, specifically concerning AI/algorithm performance against a set of acceptance criteria, human reader improvement with AI assistance, or standalone algorithm performance.
The document is a regulatory submission for a wound dressing, and the tests described are physical property tests, silver release tests, and microbiology tests, which are typical for this type of device, not for an AI/algorithm-based diagnostic or prognostic tool.
Therefore, I cannot provide the requested information, particularly:
- A table of acceptance criteria and the reported device performance: This information is not present. The "performance" mentioned refers to physical properties and antimicrobial activity of the dressing.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI study. The "test set" here would refer to samples used for bench testing (e.g., in vitro microbiology, material properties), not clinical data for AI validation.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as there's no diagnostic AI component requiring expert-labeled ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI-assisted device, so no such study would be performed or reported here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no standalone algorithm.
- The type of ground truth used: Ground truth for what? The document discusses standards for material properties and microbial reduction.
- The sample size for the training set: Not applicable, as there is no AI model or training set.
- How the ground truth for the training set was established: Not applicable.
Instead, the document details a comparison to predicate devices, material composition, and the following non-clinical (bench) tests:
- Physical properties testing: Demonstrated comparable results with predicate devices, complying with finished product specifications.
- Silver release testing: Showed less than 0.5 mg/cm² total release over seven days, with a similar release profile to predicate devices.
- Microbiology testing: Demonstrated greater than four log reduction against specific organisms (e.g., Pseudomonas aeruginosa, Staphylococcus aureus, MRSA, VRE).
- Biocompatibility testing: Evaluated according to BS EN ISO 10993, Part 1 (2009), demonstrating safety for intended purpose.
The acceptance of this device for 510(k) clearance was based on its substantial equivalence to previously cleared predicate devices and the successful completion of these non-clinical tests, which show the device performs as intended and is safe. It is a traditional medical device (wound dressing), not a software or AI-driven diagnostic/therapeutic device.
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