(152 days)
The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.
Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.
Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.
Urgocell® Ag is composed of three layers :
- in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
- a non-sensitising, super-absorbent polyurethane foam pad, -
- a protective, semi-permeable polyurethane backing. -
The provided text describes the 510(k) premarket notification for Urgocell® Ag, an antimicrobial wound dressing. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving device performance through a clinical or standalone study as one might expect for a novel AI/software device.
Therefore, many of the requested points regarding AI/algorithm performance and study design are not applicable to this 510(k) submission for a wound dressing.
Here's an analysis based on the provided text, addressing the applicable points and noting where information is not available or relevant:
Description of Acceptance Criteria and Study for Urgocell® Ag Antimicrobial Wound Dressing
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Study Goal | Reported Performance/Outcome |
|---|---|---|
| Safety | Cytotoxicity | Comparable to predicate devices and other silver-containing wound dressings. |
| Safety | Irritation | Comparable to predicate devices and other silver-containing wound dressings. |
| Safety | Sensitization | Comparable to predicate devices and other silver-containing wound dressings. |
| Antimicrobial Activity | Activity against MRSA | Comparable to predicate devices. |
| Antimicrobial Activity | Activity against Pseudomonas aeruginosa | Comparable to predicate devices. |
| Antimicrobial Activity | Activity against Streptococcus pyogenes | Comparable to predicate devices. |
| Substantial Equivalence | Comparison to Predicate Devices (Contreet-Foam, Urgotul® Ag) | All three contain silver as the active antimicrobial agent. All three provide comparable functions and indications for use. Urgocell® Ag is substantially equivalent. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The submission describes in vitro (biocompatibility and antimicrobial) and comparative design studies, not a clinical "test set" in the context of an AI/software device. The biological studies would have used laboratory samples (e.g., cell cultures, animal models for irritation/sensitization, bacterial cultures). Specific sample sizes for these in vitro and animal studies are not provided in this summary.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these general safety and antimicrobial tests. These are typically standard laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/software device requiring expert ground truth for image or diagnostic interpretation. The "ground truth" for the safety and antimicrobial studies would be laboratory measurements and established biological responses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This type of adjudication is relevant for human expert review in diagnostic studies, not for the in vitro and animal safety/efficacy tests described for this wound dressing.
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:
- Not Applicable. This is a wound dressing, not an AI or imaging device with human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device (wound dressing), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Safety Studies (Cytotoxicity, Irritation, Sensitization): Ground truth would be established by standard biological assays and the observed cellular or animal responses according to scientific protocols (e.g., cell viability, erythema scores, immune responses).
- For Antimicrobial Activity Studies: Ground truth would be established by microbiological methods measuring bacterial growth inhibition or reduction, typically compared against control groups and predicate devices.
- For Substantial Equivalence: The ground truth for substantial equivalence is the demonstration of comparable characteristics (material, function, indications for use, safety, and effectiveness) to already legally marketed predicate devices, assessed by FDA.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device. The studies described are for physical and biological properties of a wound dressing.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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