(15 days)
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including: Post-operative wounds Trauma wounds . . Leg Ulcers . Pressures Ulcers . Diabetic Ulcers Graft and donor sites . Silver Alginate II Dressing is indicated for external use only.
Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. . Odour reduction results from the antibacterial effect in the dressing. Silver Alginate II Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help to reduce infection in moderate to heavily exuding partial to full thickness wounds. The dressing has an off-white appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm, 20cm x 30cm flat dressings; 2.7cm x 30cm and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat rope dressings are packaged in pouches and the flat rope and rope dressings are packaged in a blister pack.
The provided text describes a Special 510(k) Device Modification for the Silver Alginate II Dressing. This submission primarily focuses on demonstrating substantial equivalence to a previously cleared version of the same device (K041316) and another predicate device (Aquacel Ag with hydrofibre, K013814).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (from "Testing" and "Statement of Substantial Equivalence" sections) |
|---|---|
| Biocompatibility | Compliance with the requirements of BS EN ISO 10993-1. |
| Key Performance Characteristics | Demonstrated to be substantially equivalent to predicate devices. Specifically noted: "Comparable absorbency, silver release profile and antimicrobial activity have been demonstrated." |
| Antimicrobial Activity | The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. Odour reduction results from the antibacterial effect in the dressing. The dressing has an effective barrier to bacterial penetration, which may help reduce infection in moderate to heavily exuding partial to full thickness wounds. |
| Absorbency | As wound fluid is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. (Stated in device description, reinforced by "comparable absorbency" in substantial equivalence statement). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state a specific "test set" sample size or its provenance in terms of country of origin or retrospective/prospective nature. The studies mentioned are primarily in-vitro testing and biocompatibility assessments, which typically do not involve human subject "test sets" in the same way clinical trials do.
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 provided in the document. Given that the studies appear to be in-vitro and laboratory-based (biocompatibility, microbiology, absorbency), there would likely not be a "ground truth" established by clinical experts for a "test set" in the traditional sense of diagnostic or clinical outcome studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The nature of the testing described (biocompatibility, in-vitro performance) does not typically involve adjudication methods used in clinical or image-based diagnostic studies.
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
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This submission is for a medical dressing, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a wound dressing and does not involve algorithms or human-in-the-loop performance like AI systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific tests mentioned:
- Biocompatibility: The "ground truth" is adherence to the standards defined in BS EN ISO 10993-1. This is a regulatory/technical standard.
- Antimicrobial Activity, Absorbency, Silver Release Profile: The "ground truth" for these in-vitro tests would be established through laboratory measurements and comparisons to the performance characteristics of the legally marketed predicate devices. This is based on objective, quantifiable laboratory data, not expert clinical consensus or pathology in the typical sense.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of this device and its evaluation. Training sets are relevant for machine learning or AI models, which are not involved here.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth established for one.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as:
- Biocompatibility testing: This demonstrated compliance with BS EN ISO 10993-1. (Detailed results or methodology are not provided, only the statement of compliance).
- Additional in-vitro testing and microbiological assessment: These studies demonstrated "comparable absorbency, silver release profile and antimicrobial activity" to the predicate devices. The document highlights the antimicrobial effect of silver ions against a broad spectrum of microorganisms for up to 21 days (based on in-vitro testing) and the dressing's barrier function.
The overall approach to proving acceptance criteria was based on demonstrating substantial equivalence to existing legally marketed predicate devices through a combination of standard biocompatibility testing and targeted in-vitro performance assessments (absorbency, silver release, antimicrobial activity). The specific details of these in-vitro studies (e.g., sample numbers for microbial strains, specific absorbency values, raw data) are not included in this summary document, which is typical for a 510(k) submission summary. The FDA granted clearance based on this presented evidence of substantial equivalence.
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