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Abrasions and lacerations, dermal wounds, donor sites, first- and second-degree burns, surgical incisions, vascular access sites, pressure ulcers stages I-IV, stasis ulcers, venous ulcers.

Algidex Ag® silver alginate wound dressings are an antimicrobial barrier for up to three (3) days. The dressings utilize a formulation of ionic silver combined in an alginate and maltodextrin matrix. The silver is intended to prevent microbes from passing through the dressing during use. The dressings are offered in two configurations:

1. a paste;
2. a paste applied to a non-adherent polyurethane foam layers in various sizes and shapes;
   The device is sterilized by gamma irradiation.

The provided document is a 510(k) premarket notification for a medical device (wound dressing) and DOES NOT contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

This document describes a traditional 510(k) for a physical medical device, the "Algidex Ag Silver Alginate Wound Dressing." The submission focuses on demonstrating substantial equivalence to predicate devices (SilverSite and Calgitrol Ag) based on technological characteristics and performance tests related to the physical properties and antimicrobial effectiveness of the wound dressing.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are highly relevant to AI/ML medical device submissions, where algorithms are evaluated for their diagnostic or predictive performance against established ground truth.

Therefore, I cannot extract the requested information from this document because it is not an AI/ML device submission.

The document discusses "performance tests" for the wound dressing, which are entirely different from the performance evaluation of an AI algorithm. For instance, it mentions:

• AATCC 100 test method: This is a standard test for antibacterial activity of fabrics.
• Antimicrobial barrier testing: Evaluating the dressing's ability to prevent microbial passage.
• Absorbency test: Measuring fluid absorption.

These are not related to AI model performance metrics like sensitivity, specificity, AUC, human reader improvement, or ground truth established by expert consensus on imaging data.

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Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.

Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven pad composed of a calcium (and sodium) alginate and a silver nylon contact layer. The dressing is available in various sizes ( 2" x 2", 4.2", 4.25" x 4.25", 4" x 8", 8" x 12", and a %" x 12" rope) and packaged in Tyvek pouches. The release of silver ions provides an antimicrobial barrier, which protects the dressing from microbial colonization. The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.

The provided text describes a 510(k) summary for the Silverlon™ CA Calcium Alginate Dressing. However, it does not contain the acceptance criteria or the study details that you've requested.

The document focuses on:

• Device Identification: Name, submitter, contact information.
• Predicate Device: Claims equivalence to prior Silverlon products and other marketed alginate dressings.
• Device Description: Sterile, non-woven calcium alginate pad with a silver nylon contact layer for antimicrobial barrier and exudate absorption.
• Intended Use/Indications: For moderate to heavy exudating partial and full-thickness wounds (pressure ulcers, venous ulcers, diabetic ulcers, donor/graft sites, traumatic/surgical wounds, 1st and 2nd-degree burns). External use only.
• Technological Characteristics Comparison: States silver content and alginate amount per square inch are identical to the predicate device.
• Performance Data: Mentions non-clinical studies showing good balance of tolerability and safety. These studies are:
  • Systemic Injection Test in Mice
  • Cytotoxicity - Agar Diffusion
  • Primary Dermal Irritation in Rabbits
• FDA Clearance Letter: Confirms substantial equivalence determination based on the 510(k) submission.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the given text.

The document only details non-clinical safety and tolerability tests (Systemic Injection, Cytotoxicity, Dermal Irritation) which are part of demonstrating safety, but not specific performance acceptance criteria for its indicated uses (e.g., wound healing rates, infection reduction rates) or clinical study results to prove those.

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