(154 days)
Under the supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds:
- · Pressure ulcers (partial and full thickness)
- · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- · Diabetic foot ulcers
- · Surgical wounds that heal by primary intent such as dermatological and surgical incisions
- · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites
- Traumatic wounds
Silver High Performance Dressing is a sterile dressing comprising of an absorbent non-woven fiber pad or ribbon containing ionic silver, with a reinforcement layer to allow intact application and removal of the dressing. The dressing is soft and conformable to anatomical contours. Silver High Performance Dressing manages exudate in moderate to heavily exuding wounds and helps create a favorable environment for moist wound healing. The highly absorbent dressing absorbs exudate from the wound to form a soft gel that intimately conforms to the wound bed and aids in maintaining a moist wound environment, which is conducive to the wound healing environment and aids autolytic debridement (removal of non-viable tissue). The dressing is designed to minimize the risk of maceration and damage to newly formed tissue. Silver High Performance Dressing can be used under compression. Silver High Performance Dressing contains ionic silver, and effectively manages and suppresses colonization and proliferation of bacteria and yeast within the dressing for up to 7 days. Silver High Performance Dressing , when tested in vitro, has been shown to be effective against the following four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Streptococcus mutans and Staphylococcus aureus and Methicillin - resistant staphylococcus epidermidis (MRSE)), four gram negative bacteria (Enterobacter cloacae, Klebsiella pneumonia, Serratia marcescens and Escherichia coli (E. coli)), and yeast (Candida albicans) challenge organisms within the dressing. The dressings are supplied sterile (gamma irradiation) in a range of sizes, ranging in area from 28cm² (4.34 in-) to 650cm² (100.75 in4).
The provided document {0-6} is a 510(k) premarket notification for the "Silver High Performance Dressing" by Advanced Medical Solutions Ltd. This document primarily focuses on establishing substantial equivalence to a predicate device (AQUACEL® Ag Hydrofiber Dressing - K080383) rather than detailing clinical study results for novel acceptance criteria of an AI/ML medical device.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI/ML device meets them, specifically:
- No table of acceptance criteria and reported device performance for an AI/ML device.
- No sample size for a test set for an AI/ML device, nor its data provenance.
- No information on experts used for ground truth establishment.
- No adjudication method for a test set.
- No multi-reader multiple-case (MRMC) comparative effectiveness study with human readers.
- No standalone (algorithm only) performance for an AI/ML device.
- No type of ground truth used in the context of an AI/ML device (e.g., expert consensus, pathology, outcomes data).
- No sample size for a training set or how its ground truth was established, as this is not an AI/ML device submission.
The studies described in the document are primarily in vitro and animal studies (porcine model) assessing the physical characteristics (absorbency, wet integrity, tensile strength), antimicrobial efficacy of silver, and biocompatibility/wound healing performance of the dressing itself, in comparison to a predicate device. This is typical for a wound dressing submission, not an AI/ML diagnostic or assistive device.
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