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For Over-the-Counter Use: AQUACELTM Ag+ EXTRA Enhanced Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: Abrasions, Lacerations, Minor cuts, Minor scalds and burns. Under the supervision of a healthcare professional: AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; Partial thickness (second degree) burns; Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular); Traumatic wounds; Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; Management of painful wounds; Infected wounds.

AQUACEL™ Ag+ EXTRA™ Enhanced Hydrofiber™ dressing with Silver and Strengthening Fiber is a soft, sterile dressing made from two layers of 1.2% ionic silver impregnated sodium carboxymethylcellulose fiber with added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride and stitched together with strengthening fibers. The two Hydrofiber™ layers are nominally 77gsm (grams per square meter) weight each. Aquacel Ag+ also includes added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride (BECL).

The provided text describes a 510(k) premarket notification for the AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (Device Name: K173675). The notification aims to establish substantial equivalence to a predicate device, AQUACEL Ag EXTRA Hydrofiber Dressing (K121275).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML device performance (e.g., target specificity, sensitivity, or AUC values). Instead, it focuses on demonstrating equivalence to a predicate device through various tests.

The core "acceptance criteria" for this 510(k) submission appear to be:

• Biocompatibility: The device must be safe for its intended use, as demonstrated by standard biocompatibility testing.
• Performance (Bench): The device must exhibit physical properties and preservative action comparable to or improved upon the predicate device, especially regarding antimicrobial efficacy and wound management characteristics.
• Performance (Animal Study): The device must not hinder the wound healing process and should perform comparably to the predicate device in a relevant in vivo model.
• Substantial Equivalence: Overall, the device must be shown to be as safe and effective as the predicate device, despite the addition of new components (EDTA and BECL).

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (Animal Study): The text mentions a "porcine model" but does not specify the exact number of animals or wounds used in the study.
• Data Provenance: The animal study was conducted using a porcine model, which is a common pre-clinical model for wound healing. The location of the study is not specified, but it's a prospective experimental study.
• Test Set (In vitro studies): No specific sample sizes (e.g., number of bacterial cultures or dressing samples) are given for the in vitro tests. These are laboratory-derived data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not provided in the document. For non-AI/ML medical devices like wound dressings, "ground truth" is typically established through objective measurements (e.g., bacterial count reduction in vitro, histological analysis in animal models) rather than expert consensus on images or clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. As noted above, the "ground truth" for this type of device study is based on objective laboratory and animal model measurements, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, this was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document describes a wound dressing, not an AI/ML diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a medical product (wound dressing), not an algorithm or AI system. Its performance is inherent in the physical and chemical properties of the dressing itself.

7. The Type of Ground Truth Used:

• In vitro studies: Objective laboratory measurements of bacterial growth reduction, bacterial penetration, moisture retention, gelling, absorption, tensile strength, and dry fabric properties.
• Animal study: Objective measurements of biological outcomes in a porcine model, such as rate of epithelialization, white cell infiltrate, and granulation tissue formation, likely derived from histological analysis or direct observation/measurement.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical wound dressing, not an AI/ML device that requires a training set. The "training" in this context would be the research and development phase involving materials science and biological testing to optimize the dressing's composition and manufacturing.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

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