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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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The D-Stat Dry Silver and D-Stat Dry Clear Silver are applied topically as an adjunct to manual compression and are indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry Silver and D-Stat Dry Clear Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

The D-Stat Dry Wrap Silver hemostatic bandage and Thrombix Silver Hemostasis Patch are applied topically as an adjunct to manual compression and are indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes. D-Stat Dry Wrap Silver and Thrombix Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

The D-Stat Dry Silver, D-Stat Dry Clear Silver, D-Stat Dry Wrap Silver and Thrombix Silver products are non-woven gauze pads lyophilized (frecze-dried) with procoagulant (thrombin, calcium chloride and sodium carboxymethylcellulose) and antimicrobial (ionic silver water) components. The D-Stat Drv/Wrap/ Thrombix pad creates a physical barrier to blood flow and facilitates hemostasis by the physiological coagulation-inducing properties of the lyophilized pad combined with compression. The lyophilized components (including thrombin) facilitate hemostasis through enzymatic cleavage and conversion of fibrinogen to fibrin. These products contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad and have not been clinically tested for their ability to reduce local infection, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI .

In the presence of fluids (i.e., blood and wound fluids), ionic silver is released from the silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. Ionic silver, an atom of silver that is missing one electron, provides the antimicrobial property by altering the protein structure and preventing bacterial cells from carrying out normal functions. The D-Stat Silver products demonstrated an antimicrobial effect in AATCC Test Method 100-2004 and Zone of Inhibition laboratory testing.

An adhesive foam or clear bandage accompanies some products in the family. All products are sterilized by electron-beam irradiation and are intended for single use only.

The provided text is a 510(k) summary for the D-Stat Dry Silver product family. It describes the device, its intended use, and provides a summary of studies performed to demonstrate substantial equivalence to previously marketed predicate devices.

However, the document does not provide specific acceptance criteria or detailed study results in a format that allows for the creation of a table comparing acceptance criteria to reported device performance. It also lacks specific details on sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth as requested in the prompt. While it mentions some studies, it does not present them as standalone performance studies or MRMC comparative effectiveness studies.

Based on the information available in the provided text, here is a breakdown addressing the prompt's requirements, with explicit notes where information is not present:

Acceptance Criteria and Device Performance Study

The document states that "The subject device met all established specifications in the design verification bench testing" and "Statistical evaluation of data from an acute topical laceration study in a porcine model showed the time-to-hemostasis for the D-Stat Dry Silver did not exceed the time-to-hemostasis for the D-Stat Dry (no silver)." This indicates that the primary performance criterion for hemostasis was non-inferiority to the predicate device. For antimicrobial properties, the criterion was a "greater than a 4 log reduction in microbial population" and "comparable zones" to silver-containing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Hemostasis Study): Not explicitly stated, only mentioned as "an acute topical laceration study in a porcine model."
• Sample Size (Antimicrobial Testing): Not explicitly stated for the number of samples or replicates.
• Data Provenance: The hemostasis study was conducted in a "porcine model," indicating an animal study. Other tests (bench, in vitro) are laboratory-based. No country of origin is specified for these studies, nor is it explicitly stated if they were retrospective or prospective, though the nature of these tests suggests they were prospective studies conducted for regulatory submission.

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

• Not Applicable: The studies described (animal model, lab tests) do not involve human experts establishing ground truth in the way a diagnostic AI device would. The "ground truth" for these tests is based on objective laboratory measurements and observation in the animal model.

4. Adjudication method for the test set:

• Not Applicable: Given the nature of the tests (animal model observation for hemostasis, quantitative lab tests for antimicrobial activity and physical properties), independent expert adjudication as defined for imaging or diagnostic studies is not relevant or described.

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: No MRMC comparative effectiveness study was conducted or described. This device is a topical hemostat, not a diagnostic AI device requiring human interpretation of data.

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

• Partially Applicable (but not an algorithm): The device itself performs its function (hemostasis, antimicrobial action) as a standalone product. The "studies" were essentially standalone performance evaluations of the device's physical and biological properties. However, this is not an "algorithm-only" performance in the context of AI.

7. The type of ground truth used:

• Hemostasis Study: The "ground truth" was the observed time-to-hemostasis in the porcine model.
• Antimicrobial Testing: The "ground truth" was quantitative measurement of microbial population reduction and zone of inhibition size using standardized lab methods (AATCC Test Method 100-2004).
• Biocompatibility: Based on objective ISO 10993 testing endpoints (cytotoxicity, sensitization, irritation).
• Other Bench Tests: Based on objective measurements against established engineering and material specifications.

8. The sample size for the training set:

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The product development process involves design and testing, but not machine learning training.

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

• Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

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