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Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent, composite, antimicrobial barrier wound dressings indicated for local management of superficial wounds, minor burns, and abrasions and lacerations. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. Silverlon™ Island Wound Dressings may also be used under the care of a health care professional for wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Topical application of Silverlon™ Island Wound Dressings protects the wound area and the open weave of the silver-nylon fabric wound contact layer permits passage of wound fluid through the product to be absorbed by an overlying absorbent material. The silver provides effective protection of the dressing against microbial contamination.

The Over-The-Counter indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.

The Prescription Professional indications:
Wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent composite dressings with an attached adhesive tape or pad. The dressings are composed of five distinct lavers:

• Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 layers of knitted continuous nylon fiber substrate with a metallic silver surface (Silverlon™). The layers of Silverlon™ are sewn together with silver nylon thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ knitted fabric. The silver coating is a uniform 1-micron thick layer that completely covers the nylon.
• Layer 2 is Delnet P530N
• Layer 3 is a needle punched non-woven 8-ounce rayon web that absorbs drainage from the wound site.
• Layer 4 is polyurethane film that keeps external contaminants out and maintains a moist wound healing environment. (Note: Layers 2, 3, and 4 are manufactured as a laminate by AET).
• Layer 5 is a non-woven polvester fabric coated with a skin contact pressure sensitive acrylic adhesive backed with a one sided poly coated lay flat release liner. The pressure sensitive acrylic adhesive is H-566 a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The Silverlon Island Pad does not have the tape layer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silverlon™ Island Wound Dressing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to predicate devices and inherent material properties rather than defining explicit numerical performance acceptance criteria. The "reported device performance" is inferred from statements confirming the device meets certain qualities or passes specific tests.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "standard in vitro and in vivo biocompatibility tests" but does not provide details on the number of samples or subjects used in these tests.
• Data Provenance: The biocompatibility tests were conducted by North American Science Associates, Inc. (NAmSA), Northwood, Ohio. It is not explicitly stated whether the tests were retrospective or prospective, but "standard" tests are generally prospective. The country of origin for the data is the USA.

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

• This information is not provided. The document describes standard biocompatibility and material performance tests, which typically rely on established protocols and measurement techniques rather than expert consensus on a "ground truth" in the way a clinical study would for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable as the tests described are laboratory-based performance and biocompatibility assessments, not clinical evaluations requiring adjudication of expert opinions.

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

• No, an MRMC comparative effectiveness study was not done. This is a medical device (wound dressing), not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

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

• Yes, in essence, standalone performance was assessed. The "device performance" described (biocompatibility, protection against microbial contamination, absorbency, etc.) are inherent properties of the product itself, evaluated independently of human-in-the-loop interaction in a clinical setting. The tests evaluate the material's characteristics and its ability to function as intended.

7. The Type of Ground Truth Used

The ground truth used for the performance assessment described primarily involved:

• Established Test Standards: For biocompatibility, the ground truth was meeting the requirements of Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices).
• Physical and Chemical Properties Validation: For aspects like absorbency, non-adherence, and the presence of antimicrobial silver, the ground truth would be direct measurements and material analysis confirming these properties.

8. The Sample Size for the Training Set

• Not applicable. This device is a wound dressing, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The product's design and materials are based on scientific principles and manufacturing processes, not a data-driven training approach.

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

• Not applicable. As stated above, there is no "training set" in the context of this device. The "ground truth" for the device's design and expected performance comes from established scientific understanding of material properties, wound healing, and antimicrobial action, as well as the performance of predicate devices.

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