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This device may not be labeled for use on third degree burns. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. This device may not be labeled as a treatment or a cure for any type of wound.

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This document is a letter from the FDA regarding a 510(k) premarket notification for a medical device called Silverlon™ Adhesive Strip. It is a substantial equivalence letter.

As such, this document does not contain any information about:

• Acceptance criteria or reported device performance for a study.
• Sample sizes for test sets or their data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone (algorithm only) performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

This letter primarily focuses on the regulatory aspects of the device, particularly its substantial equivalence to a predicate device and the limitations on its labeling and claims.

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Professional Indications: Indicated for vascular access, central, arterial and venous IV sites, IM injection sites, abrasions, lacerations, partial thickness burns, wound drain sites and surgical incisions. Over-The-Counter Indications: First aid to help in minor cuts, scrapes, abrasions and burns.

Silver nylon strips are multi-layer, sterile, non-adherent, absorbent composite dressings with an attached adhesive tape or pad. The dressings are composed of three distinct layers: Layer 1 is a polymeric silver coated fabric circumferential covered with a uniform layer of metallic silver. Layer 2 is a needle-punched non-woven rayon web that absorbs drainage from the wound site. Layer 3 is a latex free skin adhesive and tape.

The provided document is a 510(k) summary for a medical device called Silverlon® Adhesive Strip. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's composition, intended use, and a limited set of performance data.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a quantitative manner as one might expect for a diagnostic or high-performance device. Instead, the performance assessment is qualitative, focusing on biocompatibility and lack of systemic absorption, which are foundational for safety in wound dressings.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set:
  • Animal Study: The document refers to "a full thickness animal (pig) wound model." The exact number of animals or wounds is not specified.
  • Biocompatibility Studies: These were conducted on the "Silverlon® Island Wound Dressing," and the results were deemed applicable. The sample sizes for cytotoxicity, sensitization, and acute intracutaneous reactivity studies are not specified.
• Data Provenance: The studies were conducted by North America Science Associates, Inc. (NAmSA), Northwood, Ohio. The animal study appears to be prospective research conducted specifically for this device or a substantially similar one. The biocompatibility studies were also conducted as part of the safety assessment. There is no mention of country of origin of the data beyond the location of the testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not provided in the document. For biocompatibility and animal wound models, "ground truth" is typically established through standardized laboratory assays and veterinary/pathological assessments, rather than expert consensus in the way it might be for image interpretation.

4. Adjudication method for the test set

This information is not applicable and therefore not provided as the performance data described involves laboratory and animal testing, not human readers interpreting observations that would require adjudication.

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 device is a wound dressing, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

No, a standalone algorithm performance study was not done or is not applicable. This device is a physical wound dressing and does not involve any algorithms or AI component.

7. The type of ground truth used

• For the animal study: The ground truth for local cytotoxicity and systemic absorption would be established by veterinary/pathological assessment (e.g., histological examination of wound tissue, chemical analysis of blood samples).
• For biocompatibility studies: The ground truth would be established by standardized laboratory assays for cytotoxicity, sensitization, and acute intracutaneous reactivity, based on ISO 10993 standards.

8. The sample size for the training set

Not applicable and not provided. This device is a physical product, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable and not provided. As above, there is no training set for this type of device.

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