(250 days)
Under the supervision of a healthcare professional:
AQUACEL® Ag Surgical may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.
AQUACEL® Ag Surgical Dressing with Silver is a one piece post-operative dressing comprised of an inner (wound contact) non-woven pad which is held in place by two layers of skin-friendly hydrocolloid adhesive and an outer top layer of polyurethane film. The nonskin moraly if your over of and innic silver sitems and ionic silver stitchbonded with nylon and elastane yarn for dressing extensibility (so the ressing will stretch and be eiastane yairi for drossing oxiension (after limb movement the dressing will return to its original shape and size without the application of any additional force to the skin).
The one-piece dressing design provides ease of application and removal and provides a waterproof, bacterial, and viral barrier covering to the wound. The benefits provided by this waterproof, at the clinical need for improved management of surgical wounds which have wound drainage and are at risk of infection.
AQUACEL® Ag Surgical combines the absorbency/retention properties of AQUACEL® Ag AQUACEL Ag Surgical combines the absorbonomics of DuoDERM® Extra Thin adhesive.
AQUACEL® Ag Surgical dressing is a soft, sterile, non-woven pad composed of hydrocolloid fibers. This conformable and highly absorbent dressing absorbs wound fluids, creating a soft gel which maintains a moist environment and supports the body's healing process.
The provided text describes the AQUACEL® Ag Surgical dressing and its substantial equivalence to a predicate device, AQUACEL® Ag Hydrofiber® Dressing (K080383). However, it does not contain acceptance criteria for device performance, nor details of a specific study to prove the device meets such criteria.
Instead, the documentation relies on the safety and effectiveness demonstrated by the predicate device (K080383) and a literature review.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided. The text mentions a "literature review" and "clinical data provided in previous 510(k)s" without specifying the sample size or provenance for this specific submission's evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no specific test set described for this submission.
- Adjudication method (e.g., 2+1, 3+1, none) 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: Not applicable. This is a medical dressing, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical dressing, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for this device's evaluation, beyond relying on the "safety and effectiveness" demonstrated by the predicate and literature, which would imply clinical outcomes.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable.
Summary of available information regarding demonstration of effectiveness:
The submission states that:
- "Since AQUACEL® Ag Surgical dressing is based on the AQUACEL® Ag Hydrofiber® technology, the safety and effectiveness of AQUACEL® Ag Surgical has been demonstrated by the literature and clinical data provided in previous 510(k)s (i.e., K080383)."
- "In summary, a careful and thorough review of the literature suggests that Hydrofiber® dressings have been used safely and effectively in clinical trials for the management of-surgical incisions healing with primary intent."
- "All the studies which have been reviewed suggest that, compared to a standard dressing, using a dressing with AQUACEL® leads to less dressing changes."
This indicates that the device's effectiveness is primarily supported by:
- Substantial equivalence to the predicate device (AQUACEL® Ag Hydrofiber® Dressing, K080383).
- A literature review of Hydrofiber® dressings, highlighting their safe and effective use in clinical trials, particularly noting fewer dressing changes compared to standard dressings.
N/A