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AQUACEL® Ag Surgical SP 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.

Under the supervision of a healthcare professional, AQUACEL™ Ag Surgical SP cover dressing 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 SP dressing is a sterile post-operative dressing comprising of an inner (wound contact) non-woven pad composed of Hydrofiber™ technology and ionic silver which is stitch bonded with nylon and elastane yarns. The pad is held in place between a top layer of hydrocolloid adhesive which is bound to an outer polyurethane film and a windowed skin contact layer consisting of polyurethane film sandwiched between one layer of acrylic and one layer of Hydrocolloid contacting the skin.

The outer layer of polyurethane film of AQUACEL™ Ag Surgical SP dressing provides a bacterial and viral barrier to reduce the risk of infection provided the dressing remains intact and there is no leakage.

The highly absorbent central Hydrofiber™ pad absorbs and retains serosanguinous leakage and transforms into a soft gel which maintains a moist environment to support the body's healing process.

The hydrocolloid component of the dressing provides secure, skin friendly adhesion and supports non traumatic removal of the dressing while minimizing damage to the intact surrounding skin.

AQUACEL™ Ag Surgical SP dressing is a waterproof, bacterial and viral barrier dressing which is designed to conform to changes in the wound/incision geometry during body movement and post-operative edema.

The dressing is intended for single use and is provided sterile (via a gamma irradiation process).

This Special 510(k) details the modifications of the predicate device, AQUACEL™ Ag Surgical dressing, which form the AQUACEL™ Ag Surgical SP dressing. These modifications do not alter the intended use or indications for use.

This document is a 510(k) Summary for the AQUACEL™ Ag Surgical SP Dressing, demonstrating its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way a diagnostic AI device would. Instead, it focuses on non-clinical testing to show performance comparability and safety.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document in the typical sense for a diagnostic device. However, I will answer the questions based on the information provided, explicitly stating where the information is not available or not applicable.

Here's an interpretation of the request in the context of this document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical thresholds in the way a diagnostic AI would have for sensitivity, specificity, etc. Instead, the acceptance criterion for this submission is substantial equivalence to the predicate device based on comparable functional and structural design parameters and biological safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "non-clinical testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is not a diagnostic device involving expert interpretation or ground truth establishment in that manner. The evaluation is based on laboratory/bench testing and biological assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the reasons stated above.

5. 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 information is not applicable. This is not an AI/diagnostic device; no human reader studies or MRMC studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is based on established testing methodologies and standards for medical device performance (e.g., fluid handling, adhesion strength, biocompatibility testing) for which the predicate device's performance already set a benchmark. It is not expert consensus, pathology, or outcomes data in the diagnostic sense.

8. The sample size for the training set

This information is not applicable. There is no training set as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

This information is not applicable. There is no training set.

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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:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. 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.
3. 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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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.
6. 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.
7. 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.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
9. 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.

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