(25 days)
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:
- Pressure ulcers
- Leg ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- Trauma wounds (dermal lesions, trauma injuries or incisions)
- 1st and 2nd degree burns
- Abrasions and lacerations
Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing. Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel. Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.
The provided text is a 510(k) summary for a medical device modification, specifically for a Silver Antimicrobial Wound Gel. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not include specific acceptance criteria with quantifiable metrics (e.g., "device must achieve X% sensitivity or Y% specificity"). Instead, it focuses on demonstrating performance through qualitative statements and comparisons.
Therefore, for the requested table of acceptance criteria and device performance, I can only extract what is stated. For other sections, the information is largely absent based on a typical AI/software device study description.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a device modification for a wound care product, not an AI software), the "acceptance criteria" are not presented as numerical thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating antimicrobial barrier activity and acceptable wound healing performance compared to a predicate device and standard care.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| In-vitro Antimicrobial Barrier Activity | Effective against: Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus brasiliensis (formerly Aspergillus niger) when they come into contact with the gel. Demonstrated by a seven-day log reduction evaluation test and preservative efficacy test (USP 33 and European Pharmacopoeia Edition 6.6 section 5.1.3). The clinical implications of the in-vitro findings are unknown. |
| Biocompatibility | Compliant with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). |
| In-vivo Wound Closure Rate (compared to predicate/control) | "The report findings showed that the rate of wound closure in receipt of Silver Antimicrobial Wound Gel showed no significant differences when compared to the Hydrogel and 'Wet to Dry' gauze treatment." |
| In-vivo Wound Adherence (compared to predicate/control) | "Wound site adherence...was not detected for the Silver Antimicrobial Wound Gel or Hydrogel at any point in the study" (significant in "Wet to Dry" gauze treated wounds). This indicates better performance than "Wet to Dry" gauze. |
| In-vivo Peri-wound Inflammation/Erythema | "Peri-wound inflammation/erythema was less frequently observed and less severe in Silver Antimicrobial Wound Gel and Hydrogel treated wounds than in similar control 'Wet to Dry gauze' treated wounds." This indicates better performance than "Wet to Dry" gauze. |
| In-vivo Adverse Effects | "No adverse effects were noted following the use of either of the Silver Antimicrobial Wound Gel or the Hydrogel 'dressings' investigated." |
| Substantial Equivalence to Predicate Device (K073197) | "The Silver Antimicrobial Wound Gel...is substantially equivalent to Advanced Medical Solutions Limited's Antimicrobial Wound Gel, 510(k) # K073197." This is the overarching acceptance criterion for the 510(k) submission. Demonstrated through the above testing, biocompatibility, and antimicrobial activity. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of subjects or wounds for the in-vivo porcine study. It only mentions "an in-vivo porcine study."
- Data Provenance: The in-vivo study was a porcine study (animal model). The country of origin for the data is not specified, but the applicant is based in the United Kingdom. It is a prospective study as it describes an assessment over time ("day 2 & 4 assessment points").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. The in-vivo study involved direct observation and measurement of wound characteristics in a porcine model, rather than expert interpretation of images or clinical data for ground truth establishment in the way an AI medical device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in clinical image interpretation, not for direct observations in an animal model.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a wound care gel.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a wound care gel, not an algorithm. Therefore, "standalone" performance in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in-vivo study, the "ground truth" (or outcome measures) were direct observations of wound closure rate, wound site adherence, peri-wound inflammation/erythema, presence of debris, and adverse effects in a porcine model. These are direct physical measurements and observations.
- For the in-vitro study, the ground truth was based on laboratory testing against specified microorganisms following recognized standards (USP 33 and European Pharmacopoeia Edition 6.6 section 5.1.3).
8. The sample size for the training set
- Not applicable. This is a medical device (wound gel), not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this device.
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