(90 days)
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, 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.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for acute cutaneous radiation injury including moist desquamation without full thickness skin ulceration and/or necrosis.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barner 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. Silverlor® 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, wraps, and gloves) and sizes.
I am sorry but the provided text is a 510(k) summary for a medical device (wound dressing) and does not contain information about acceptance criteria and study details as typically found for AI/ML-based medical devices. The document explicitly states that the current device is "identical products and thus have identical technological characteristics" to a previously cleared predicate device. Therefore, no new performance studies (such as those involving AI/ML components) were conducted to establish acceptance criteria or prove performance against a ground truth.
The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and a swine study for a new indication (cutaneous radiation injuries). It does not discuss AI/ML algorithm performance, test sets, ground truth establishment by experts, or MRMC studies.
Therefore, I cannot provide the requested information based on the given text.
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