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

RX Use
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites, and wound drain sites.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis and cutaneous radiation injury through dry desquamation.

Silverlon® Wound Contact, Burn Contact 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® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

The Silverlon® Wound Contact, Burn Contact Dressings (WCD/BCD) are sterile, single use, single layer, non-adherent antimicrobial barrier wound dressings for up to seven day use. The dressings are comprised of Silverlon knitted nylon material plated with 99% elemental silver and 1% silver oxide. When Silverlon® dressings are moistened, the silver ions are activated, which kill wound bacteria held in the dressing which may help to reduce wound infection. The dressings are used as primary dressings that conform to the wound surface. The dressings are available in several configurations (e.g., rectangular, chest/trunk aprons, face masks, wraps, and gloves) and sizes.

The provided text describes the performance data for Silverlon Wound Contact, Burn Contact Dressings but does not specify acceptance criteria or present the information in a clear "acceptance criteria vs. reported performance" table format. The study aims to demonstrate safety and feasibility, and to show non-inferiority in terms of radiation dermatitis severity compared to historical controls.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format for the clinical study. Instead, it focuses on demonstrating safety and feasibility, and comparing radiation dermatitis grades with a historical cohort.

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

• Sample Size (Clinical Study): 30 patients were enrolled in the interventional clinical study.
• Sample Size (Matched Cohort): 90 historical patients were matched (3 historical patients per clinical trial subject). For the comparison of RD grades, a subset of 71 matched cohort patients had documented RD grades.
• Data Provenance: The interventional clinical study was an open label, single site, single arm, unblinded study. The text does not explicitly state the country of origin, but it is implied to be within the US due to FDA submission. The historical data for the matched cohort was from the "same study sites" within a four-year window of the clinical trial.
• Retrospective/Prospective:
  • The Silverlon study data is prospective (interventional clinical study).
  • The matched cohort data is retrospective (historical patients).

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

The document does not specify the number of experts used to establish the ground truth or their qualifications. The "documented radiation dermatitis (RD) grades (either RTOG or CTCAE)" imply that these were assigned clinically, likely by treating physicians or radiation oncologists, but no details on their number or specific expertise are provided.

4. Adjudication method for the test set

The document does not describe any specific adjudication method for determining the RD grades for either the clinical trial subjects or the matched cohort. The grades were "documented," suggesting standard clinical assessment.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study is for a wound dressing, not an AI or imaging device with human readers.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical wound dressing, not an algorithm.

7. The type of ground truth used

The ground truth for the radiation dermatitis grades was based on clinical assessment using standardized scales (RTOG or CTCAE scale) as documented in patient records.

8. The sample size for the training set

This section is not applicable as the document describes a physical medical device (wound dressing) and a clinical trial. There is no mention of an algorithm or a training set for an AI model.

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

This section is not applicable for the same reason as point 8.

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