(148 days)
Under the supervision of a healthcare professional Surgical Silver Post Operative Dressing may be used in the management of post operative surgical wounds healing by primary intent, and as an effective barrier to bacterial penetration.
The subject device, Surgical Silver Post Operative dressing, is a sterile dressing comprising of an absorbent non woven pad containing an ionic silver. This centered silver pad is secured between two layers of hydrocolloid; the outer hydrocolloid layer incorporates a breathable waterproof film. The inner layer of hydrocolloid forms a windowed self adhesive skin contact layer, which adheres to healthy skin, minimizes trauma on removal and assists in minimizing leakage. As wound fluid is absorbed the dressing forms a gel, this helps maintain a moist environment. A moist wound environment has been shown to be conducive for wound healing. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.
Based on in vitro performance data, the Surgical Silver Post Operative dressing provides a barrier to bacterial penetration through the dressing and the silver component prevents colonization and proliferation of bacteria within the dressing for up to 7 days.
Surgical Silver Post Operative dressings, when tested in-vitro have been demonstrated to be efficacious, achieving ≥4 log reduction within the dressing including multiple re-inoculations against three gram positive (MRSA, MRSE, VRE) bacteria, three gram negative bacteria ( Escherichia coli, Klebsiella pneumonia, Pseudomona areuginosa ) and yeast ( Candida albicans ) challenge organisms.
The dressings are supplied sterile (gamma irradiation) in a range of sizes between 14 in 2 to 49 in 2 .
The device, Surgical Silver Post Operative Dressing, is subjected to various performance tests to demonstrate its substantial equivalence to the predicate device, AQUACEL® Ag Surgical dressings (K091034). The studies cited include in-vitro performance data, animal testing, and biological evaluation.
Here's an breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Barrier / Silver Efficacy (In-vitro) | ≥4 log reduction in bacterial colonization and proliferation within the dressing for up to 7 days, including multiple re-inoculations. | Achieved ≥4 log reduction within the dressing against 3 gram-positive bacteria (MRSA, MRSE, VRE), 3 gram-negative bacteria (Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa), and yeast (Candida albicans). |
| Total Fluid Handling | (Not explicitly stated, but implied to be comparable to predicate) | Performed, results led to a conclusion of substantial equivalence. |
| Absorbency over 7 days | (Not explicitly stated, but implied to be comparable to predicate) | Performed, results led to a conclusion of substantial equivalence. |
| Peel Adhesion | (Not explicitly stated, but implied to be comparable to predicate for securing dressing and minimizing trauma on removal) | Performed, results led to a conclusion of substantial equivalence. |
| Water Barrier | (Not explicitly stated, but implied to be effective) | Performed, results led to a conclusion of substantial equivalence. |
| Wound Healing in Porcine Model | No biologically relevant differences in local tissue effects and wound healing compared to predicate and negative control. | No biologically relevant differences amongst the test subjects (Surgical Silver Post Operative Dressing, AQUACEL® Ag Surgical dressing and a Negative Control) in terms of wound healing performance characteristics and local tolerance after wound creation. |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Material Mediated Pyrogenicity, Implantation, Sub-acute/sub-chronic toxicity) | Meets the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) and is safe. | Demonstrated to meet the requirements of BS EN ISO 10993-1 and is safe. |
2. Sample size used for the test set and the data provenance
- Bacterial Barrier / Silver Efficacy: The sample size for the in-vitro tests is not explicitly stated in terms of the number of dressings or repetitions.
- Wound Healing (Porcine Model): The document mentions "test subjects" in the porcine model, implying a number of animals were used, but the specific count is not provided.
- Biocompatibility: The sample size for the various biocompatibility tests is not specified.
- Data Provenance: The studies are described as in-vitro and animal testing, which are implicitly prospective studies designed to evaluate the device. The country of origin for the studies is not explicitly stated, but the manufacturer is Advanced Medical Solutions Ltd, based in the UK, suggesting the studies were likely conducted or overseen in the UK or by a contract research organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Bacterial Barrier / Silver Efficacy: The ground truth for bacterial efficacy (in-vitro) is established through standard microbiological testing protocols, which rely on validated laboratory methods and measurements (e.g., colony-forming unit counts). While experts perform these tests, a specific "number of experts" or their qualifications for establishing ground truth as in a clinical consensus review is not applicable in this context.
- Wound Healing (Porcine Model): The evaluation involved "macroscopic and histopathological observations." Histopathological observations typically involve trained veterinary pathologists or equivalent experts. However, the exact number and qualifications of these experts are not provided.
- Biocompatibility: These tests are conducted according to international standards (e.g., ISO 10993-1) by qualified toxicologists and laboratory personnel. The specific number and qualifications of experts are not detailed in this summary.
4. Adjudication method for the test set
- Bacterial Barrier / Silver Efficacy: No explicit adjudication method is mentioned. The results would likely be based on quantitative measurements and statistical analysis against predefined thresholds.
- Wound Healing (Porcine Model): "Macroscopic and histopathological observations" suggest subjective and objective assessments. However, no specific adjudication method like 2+1 or 3+1 for resolving discrepancies is described. Typically, a qualified pathologist's report would constitute the finding.
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 section is not applicable as the device is a medical dressing and not an AI-powered diagnostic or decision support system that would involve human readers or an AI assistance component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a medical dressing and not an algorithm. The "standalone" performance here refers to the dressing's intrinsic properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bacterial Barrier / Silver Efficacy: Ground truth is based on quantitative microbiological assays (e.g., direct enumeration of bacterial colonies) performed in-vitro.
- Wound Healing (Porcine Model): Ground truth is established through macroscopic observation of wound healing progression and microscopic histopathological examination of tissue samples.
- Biocompatibility: Ground truth is determined by the results of standardized biological tests according to ISO 10993-1, which assess cellular responses, systemic toxicity, and tissue reactions.
8. The sample size for the training set
This section is not applicable. The device is a medical dressing with performance evaluated through laboratory and animal studies, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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