(188 days)
The SimpliCare Transparent Wound Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The SimpliCare Transparent Wound Dressing provides a barrier to viral and bacterial contaminants and other external contaminates such as urine and feces. The SimpliCare Wound Dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels and foam dressings.
The SimpliCare Transparent Wound Dressing is indicated for use on wounds including:
- minor burns and scalds .
- superficial cuts, lacerations and abrasions ●
- minor irritations of the skin .
This wound dressing may also be used for non-exudating to minimally exudating partial and full thickness wounds such as:
- pressure ulcers .
- lacerations/abrasions .
- surgical incisions .
- . second degree burns
- donor sites .
In addition, the SimpliCare Transparent Wound Dressing can be used on IV sites and as a secondary fixation device
The Hollister SimpliCare Transparent Wound Dressing is a polyurethane film that is backed with a pressure sensitive acrylic adhesive. A unique closed cell foam application grid allows for easy handling of the film dressing during application to the wound sites. The Hollister Transparent Wound Dressing is designed to have a high moisture vapor transmission rate and is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Transparent Wound Dressing provides a barrier to viral and bacterial contaminates and other external contaminants such as feces and urine while the dressing remains intact without leakage.
The dressing is also intended to be used on IV sites or as secondary fixation device for products such as alginates, gels, and foam dressings.
The Hollister Transparent Wound Dressing is presented sterile and is available in a variety of sizes to accommodate various sizes of wounds.
The provided document is a 510(k) premarket notification for a medical device (Hollister SimpliCare Transparent Wound Dressing) and not a study report that describes acceptance criteria and device performance in the context of an AI/ML powered device.
Therefore, I cannot extract the requested information such as:
- A table of acceptance criteria and the reported device performance: This document does not specify performance metrics or acceptance criteria for device efficacy in the way an AI/ML study would. It describes the device's intended function and biocompatibility.
- Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of an AI/ML evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant to the type of device described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document discusses:
- Device Description: A polyurethane film dressing with a pressure-sensitive acrylic adhesive, designed for moist wound healing, barrier protection, and use on IV sites or as a secondary fixation device.
- Intended Use: Various wound types (minor burns, cuts, abrasions, pressure ulcers, surgical incisions, second-degree burns, donor sites), IV sites, and secondary fixation.
- Technological Characteristics: Permeable to moisture vapor and oxygen, material biocompatibility assessed per standards (EN 30993, G95-1, USP).
- Substantial Equivalence: Claimed to be substantially equivalent to predicate devices (Bioclusive Transparent Dressing, EpiVIEW Thin Film Dressing).
This document is a regulatory submission demonstrating the device's safety and effectiveness in comparison to existing devices, not a study evaluating an AI/ML algorithm's performance against specific acceptance criteria.
N/A