(315 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.
Prescription Indications:
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 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 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 Silverlor® 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 order): The Silverlon Wound Pad Dressing is 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 µm thick and contains approximately 1% silver oxide).
- . 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;
- . Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; 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.
This document is a 510(k) premarket notification for the Silverlon Island Wound Dressing and Silverlon Wound Pad Dressing. It does not describe a study involving an AI device or elaborate on acceptance criteria and device performance in the way requested. Instead, it demonstrates substantial equivalence to a previously cleared device. Therefore, I cannot provide the detailed information requested in the prompt.
However, based on the provided text, I can infer some aspects related to the "acceptance criteria" through the lens of device clearance and testing for a medical device that is not AI-driven:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of performance metrics in the context of an AI study. Instead, it refers to the results of standard non-clinical tests to demonstrate safety and effectiveness for a wound dressing.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from Nonclinical Testing) |
|---|---|
| Biocompatibility | All materials are biocompatible per irritation, sensitization, and cytotoxicity testing results. |
| Antimicrobial Effectiveness (Stability) | In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years, was performed. (Specific performance values like kill rates are not provided here but confirmed by testing). |
| Antimicrobial Susceptibility | Kirby-Bauer Standard Antimicrobial Susceptibility Test was performed. (Demonstrates susceptibility to the silver in the dressing). |
| Time Kill Assay for Antimicrobial Agents | ASTM E2315 Time Kill Assay for Antimicrobial Agents Report was performed. (Confirms the dressing's ability to kill microorganisms over time). |
| MR Environment Safety: Magnetically Induced Displacement Force | Testing in accordance with ASTM F2052 was completed. (Implies the device demonstrated safe displacement force within acceptable limits for MR environments, though no numerical result is given in the summary). |
| MR Environment Safety: Magnetically Induced Torque | Testing in accordance with ASTM F2213 was completed. (Implies the device demonstrated safe torque in MR environments). |
| MR Environment Safety: Heating by RF Fields | Testing in accordance with ASTM F2182 was completed. (Implies the device did not heat to an unsafe degree in MR environments). |
| MR Environment Safety: Image Artifacts | Testing in accordance with ASTM F2119 was completed. (Implies the device did not cause unacceptable image artifacts in MR environments). |
| Substantial Equivalence to Predicate Device | The subject device has the same intended use and technological characteristics as the predicate device (K143001). The expanded labeling for MR use does not raise new questions of safety or effectiveness. (This is the primary "acceptance criterion" for 510(k) clearance in this context, rather than specific performance metrics against a defined threshold for a new technology). |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable in the context of the provided document, as it describes a clearance for a physical medical device (wound dressing), not an AI algorithm. The testing mentioned (e.g., in vitro stability, biocompatibility, MR compatibility) uses samples of the device itself or biological proxies, not a "test set" of data for an algorithm. There is no data provenance in the sense of patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable. Ground truth for an AI algorithm is established by expert review of data. For this physical device, "ground truth" refers to established scientific and regulatory standards (e.g., ISO 10993, ASTM standards) that determine the device's properties. Experts involved would be those performing or overseeing these standardized tests, or regulatory reviewers evaluating the results, but not in the context of establishing "ground truth" for an algorithmic output.
4. Adjudication Method:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers when establishing ground truth for AI model training or evaluation. This document describes a physical medical device's clearance process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. An MRMC study compares human reader performance, often with and without AI assistance. This document describes a wound dressing, not an AI system.
6. Standalone Performance:
This information is not applicable. Standalone performance refers to the algorithm's performance without human intervention. The device here is a physical product.
7. Type of Ground Truth Used:
For the tests conducted, the "ground truth" refers to established scientific and regulatory standards and experimental outcomes. For example:
- Biocompatibility: Results of standardized in vitro and in vivo tests per ISO 10993.
- Antimicrobial Effectiveness: Results from standardized assays like Kirby-Bauer and ASTM E2315.
- MR Compatibility: Results from standardized tests like ASTM F2052, F2213, F2182, F2119, interpreted against pre-defined safety thresholds.
- Substantial Equivalence: Comparison against the characteristics and intended use of a legally marketed predicate device as assessed by regulatory bodies.
8. Sample Size for the Training Set:
This information is not applicable. There is no AI algorithm being trained.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for an AI algorithm.
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