(21 days)
Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Rx Use
Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pu sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).
Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order): The Silverlon® Wound Pad dressings are comprised of Layers 1 - 4, they are not supplied with Layer 5 (adhesive tape layer).
- ∑ Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m2); the silver surface coating is approximately 0.8 - 1.0 µ m thick and contains approximately 1% silver oxide).
- 2 Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
- ∑ Layer 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;
- 2 Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below;
- Σ and,
- ∑ Layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner. The Silverlon® Wound Pad dressings do not have a tape layer.
All materials are biocompatible per irritation, sensitization and cytotoxicity testing results.
Layer 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provide an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.
Under the direction of a healthcare professional, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for wounds such as vascular access or peripheral IV sites, orthopedic 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) or traumatic wounds left to heal by secondary intent, and management of painful wounds.
The provided document describes the Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing and their substantial equivalence to a predicate device (K122817). However, it does not contain a detailed study proving that the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as typically requested for AI/ML device evaluations.
Instead, the document focuses on regulatory approval (510(k)) based on substantial equivalence to a previously cleared device. The "acceptance criteria" discussed are primarily related to safety and effectiveness demonstrated through biocompatibility and antimicrobial testing, rather than performance metrics for a diagnostic or AI device.
Here's a breakdown of the information available, and what is not present based on your query:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from document context) | Reported Device Performance (from document context) |
|---|---|
| Safety: | |
| * Biocompatibility (irritation, sensitization, intracutaneous reactivity) | All tests performed in accordance with ISO 10993 Standard Series for Biological Evaluation of Medical Devices. All materials are biocompatible per irritation, sensitization, and cytotoxicity testing results. |
| * No new questions of safety compared to predicate device K122817 | The technological characteristics have not changed from the previously cleared Silverlon® Island Wound Dressing (K122817). The minor changes in design (presence/absence of tape layer) do not influence technological differences, implying no new safety concerns. |
| Effectiveness: | |
| * Antimicrobial Effectiveness (long-term) | In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years. |
| * Antimicrobial Susceptibility | Kirby-Bauer Standard Antimicrobial Susceptibility Test performed. |
| * Antimicrobial Activity (Time Kill) | Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report performed. Layer 1 delivers antimicrobial silver ions, killing wound bacteria and providing an antimicrobial barrier. |
| * Maintenance of moist wound healing environment | The moist wound healing environment and control of wound bacteria within the dressing may help reduce the risk of wound infection and support the body's healing process. This dressing absorbs high amounts of wound fluid. |
| * Pain reduction during dressing changes | Non-adherent wound contact layer reduces pain during dressing changes; evaporation of moisture in the dressing may soothe the wound. |
| * No new questions of effectiveness compared to predicate device K122817 | The technological characteristics have not changed from the previously cleared Silverlon® Island Wound Dressing (K122817). The minor changes in design (presence/absence of tape layer) do not influence technological differences, implying no new effectiveness concerns. The device has the same intended use and technological characteristics as the predicate. |
Information NOT Available in the Document:
The nature of these questions suggests an AI/ML device, which this document does not describe. The information below is thus not found in the provided text.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no "test set" for performance evaluation of an AI algorithm is mentioned. The tests are in vitro (antimicrobial, and stability) and in vivo (biocompatibility) laboratory tests.
- 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)
- Not applicable. Ground truth for an AI algorithm is not established in this context. The "truth" for biocompatibility is whether the device causes adverse biological reactions; for antimicrobial effectiveness, it's the measured killing of microbes. These are determined by standard laboratory protocols.
- 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 not an AI/ML device related to human interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests involved refers to established scientific methodologies and standards. For biocompatibility, it's the absence of toxic or irritating effects as per ISO 10993. For antimicrobial activity, it's the measured reduction in microbial load according to standards like Kirby-Bauer and ASTM E2315.
- The sample size for the training set
- Not applicable. This is not an AI/ML device with a training set.
- How the ground truth for the training set was established
- Not applicable.
Conclusion:
The document is a 510(k) premarket notification letter and summary for a medical dressing, not an AI/ML device. It demonstrates substantial equivalence to a predicate device primarily through technical specifications, biocompatibility testing, and in vitro antimicrobial effectiveness tests. No clinical studies were deemed necessary for this submission. Therefore, most of the specific questions about AI/ML device evaluation criteria (test sets, ground truth experts, MRMC studies, training data) are not addressed by the provided text.
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