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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.

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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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

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.

2. 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.
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)
   • 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.
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 not an AI/ML device related to human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not applicable.
7. 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.
8. The sample size for the training set
   • Not applicable. This is not an AI/ML device with a training set.
9. 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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