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510(k) Data Aggregation
(261 days)
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
Silver Alginate IV Antimicrobial Wound Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:
- . Post-operative wounds
- Trauma wounds (dermal lesions, trauma injuries or incisions) .
- Leg Ulcers ●
- Pressures Ulcers .
- Diabetic Ulcers .
- Graft and donor sites .
- Post-operative surgical wounds
- 1st and 2nd degree burns
- Partial and Full Thickness wounds
Silver Alginate IV Antimicrobial Wound Dressing is indicated for external use only
Silver Alginate IV Antimicrobial Wound Dressing is a sterile, non woven pad or rope/ribbon/filler composed of a high M (mannuronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (silver carbonate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the dressing forms a gel, which aids autolytic debridement, whilst maintaining a moist environment for optimal wound healing and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms, such as a Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Streptococcus and bw, merceas faecalis (VRE), Pseudomonas aeruginosa, Escherichia Doli, and fungi such as Candida albicans , over a period of up to twenty-one (21) days, based on in-vitro testing, and may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver Alginate IV Antimicrobial Wound Dressing is an effective barrier to bacterial penetration. The dressing has pale golden appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 10cm x 12cm, 15cm, 10cm x 20cm, 20cm x 20cm flat dressings; 2.7cm x 30cm room, 10cm x 12cm, 150m, 150mm x 2g rope dressings). The dressings are packaged in pouches.
The provided text describes a 510(k) notification for a medical device, the Silver Alginate IV Antimicrobial Wound Dressing. This type of submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to prove efficacy against acceptance criteria. Therefore, the document primarily details the basis for equivalence rather than specific acceptance criteria and a study proving performance against them.
Based on the provided information, I can answer some of your questions and note where the information is not available:
1. Table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. For a 510(k) submission like this, the "acceptance criteria" are generally that the new device performs as well as or substantially equivalently to the predicate device in relevant tests (e.g., biocompatibility, sterilization, antimicrobial activity, absorption). The document states that the testing demonstrated compliance and substantial equivalence to predicate devices, implying these "acceptance criteria" were met.
| Acceptance Criteria (Implied from 510(k)) | Reported Device Performance |
|---|---|
| Biocompatibility in compliance with BS EN ISO 10993-1 | Demonstrated to be in compliance |
| Sterilization validation in compliance with harmonized standards | Performed in compliance |
| Antimicrobial activity against specified microorganisms for up to 21 days | Achieved based on in-vitro testing. Protects the dressing from a broad spectrum of microorganisms (e.g., Staphylococcus aureus including MRSA, Pseudomonas aeruginosa, Candida albicans) |
| Absorption and gel formation characteristics similar to predicate devices | Forms a gel and aids autolytic debridement after absorbing wound fluid |
| Barrier to bacterial penetration | An effective barrier to bacterial penetration |
| Safety and Rationale for Use | Demonstrated to be safe and effective for the indications of use |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" for antimicrobial activity, but the specific number of samples or experimental replicates is not detailed.
- Data Provenance: The manufacturing company is Advanced Medical Solutions Limited, located in the United Kingdom. The testing would presumably have been conducted in the UK or by contractors for AMS Ltd. The nature of the tests (biocompatibility, sterilization validation, in-vitro antimicrobial activity) indicates laboratory-based studies rather than human clinical trials. These would generally be considered prospective in design for the specific tests performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided. The "ground truth" concept is typically used in AI/ML studies where human experts classify data for model training and validation. For a medical device like a wound dressing, the "ground truth" for performance is established through standardized laboratory tests and validated methodologies (e.g., microbiology labs for antimicrobial activity, toxicology labs for biocompatibility). There is no mention of human experts interpreting raw test results as "ground truth" in the way it would be for an image classification task, for example.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this type of adjudication is relevant for expert-driven tasks, not for standardized laboratory performance testing of a 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
No. This is a medical device (wound dressing), not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant or discussed. The comparison is against predicate wound dressings to establish substantial equivalence, not against AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI product. The device itself is the "standalone" product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable here. For the tests cited:
- Biocompatibility: Ground truth is established by adherence to standards like BS EN ISO 10993-1, which involves specific laboratory assays (e.g., cytotoxicity, irritation, sensitization).
- Sterilization Validation: Ground truth is adherence to harmonized standards, ensuring a specified sterility assurance level (SAL).
- Antimicrobial Activity: Ground truth is established by validated in-vitro microbiological test methods demonstrating reduction or inhibition of microbial growth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this type of medical device.
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