(115 days)
The barrier functions of Urgotul Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.
Urgotul® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing, composed of a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver (2.25 mq/sq.inch).
The provided text describes Urgotul Ag, an antimicrobial wound dressing with silver, and its substantial equivalence to a predicate device (Urgotul Ag K061220). The document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. As such, it primarily details comparative characteristics and safety studies rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in efficacy trials for novel devices or AI algorithms.
However, based on the provided text, we can extract the information related to antimicrobial activity studies, which serve as the "performance" data for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Urgotul Ag K100430) |
|---|---|---|
| Antimicrobial Activity | Efficacy against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes (as demonstrated by predicate Urgotul Ag K061220). | Demonstrated antimicrobial activity against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes. Additionally, data was submitted concerning antimicrobial activity against three new strains: Enterococcus faecalis, Escherichia coli, and Candida albicans. |
| Indications for Use | "The barrier functions of Urgotul® Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites." (from predicate K062559) | "The barrier functions of Urgotul® Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites." (identical to predicate) |
| Structure/Composition | Non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing; polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly, and silver (2.25 mg/sq.inch). (from predicate K062559) | Non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing; polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly, and silver (2.25 mg/sq.inch). (identical to predicate) |
| Biocompatibility/Safety | Demonstrated non-cytotoxic, non-irritating (rabbit), and non-sensitizing (guinea pigs) (as per predicate Urgocell Ag). | Standard battery of safety and biocompatibility studies (Cytotoxicity, Irritation study in rabbit, and Sensitization study in guinea pigs) previously conducted showed the Urgocell Ag (a similar device from the same manufacturer) to be comparable to predicate devices and other silver-containing wound dressings. This implies the current device also meets these safety profiles. |
Study Details:
The document describes an antimicrobial activity study that was conducted to support the substantial equivalence claim.
2. Sample Size Used for the Test Set and Data Providence:
- Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. For the antimicrobial activity study, the "test set" consists of three new bacterial/fungal strains: Enterococcus faecalis, Escherichia coli, and Candida albicans.
- Data Provenance: The document does not specify the country of origin for the antimicrobial activity study. Given the sponsor is Laboratories URGO in France, it is plausible the studies were conducted in France or a European lab. The study appears to be retrospective in the sense that it builds upon previously conducted studies for K061220 and K062559, explicitly stating "data was submitted concerning the antimicrobial activity of Urgocell® Ag on three new strains" with this submission, implying these were studies already performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. For antimicrobial studies, "ground truth" would typically be established by laboratory culturing and identification methods, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials where human experts evaluate patient data (e.g., medical images). For laboratory-based antimicrobial activity testing, the results are typically determined by standard microbiological assays.
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:
This is not applicable. The device is an antimicrobial wound dressing, not an AI algorithm for medical image interpretation or diagnosis. Therefore, no MRMC study or AI assistance comparison was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical wound dressing, not an algorithm.
7. The type of ground truth used:
For the antimicrobial activity study, the "ground truth" would be the laboratory results from standardized microbiological assays. These assays directly measure the device's ability to inhibit or kill specific microorganisms.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not an AI algorithm that requires a training set. The safety and antimicrobial activity studies are product evaluations, not machine learning model training.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this device.
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