(189 days)
ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including:
- pressure ulcers .
- venous ulcers .
- diabetic ulcers ●
- first and second-degree burns ●
- . donor sites
- surgical wounds ●
ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging.
ACTISORB* Silver 220 Antimicrobial Binding Dressing is a sterile primary wound dressing, comprised of activated charcoal cloth, impregnated with silver, within a spun bonded nylon envelope. Within the dressing, there is 220mg silver per 100g activated charcoal cloth equating to 33ug of silver per square centimeter of cloth.
1. Acceptance Criteria and Reported Device Performance:
The provided document describes the ACTISORB Silver 220 Antimicrobial Binding Dressing* as a wound dressing. The acceptance criteria and device performance are not explicitly presented in a table format with specific quantitative metrics in the provided text.
However, the "Device Description" and "Indications for Use" sections imply general performance characteristics against which the device is implicitly accepted:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy: Effective barrier to bacterial penetration. | "ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration..." "The binding properties of the dressing trap bacteria, bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds..." |
| Odor Adsorption: Adsorbs offending odor from wounds. | "...and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor." |
| Biocompatibility/Safety: Non-toxic, non-irritating, non-sensitizing, non-cytotoxic. | "Biocompatibility studies have demonstrated ACTISORB* Silver 220 Antimicrobial Binding Dressing to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text (K022483 510(k) summary) does not contain information about a specific "test set" in the context of clinical studies for diagnostic device performance. This submission is for a wound dressing, and the focus is on substantial equivalence to existing predicate devices based on its physical properties and intended use. The "biocompatibility studies" are mentioned, but details on sample size, design, or data provenance (country, retrospective/prospective) are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to the provided document. The submission is for a wound dressing, which typically relies on pre-clinical testing (e.g., in-vitro antimicrobial efficacy, biocompatibility) and clinical experience with similar devices, rather than a "ground truth" established by experts for a diagnostic output.
4. Adjudication Method for the Test Set:
This information is not applicable to the provided document for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The provided 510(k) summary does not mention or describe a multi-reader multi-case comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human readers interpret results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This is a medical device (wound dressing), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant or applicable.
7. The Type of Ground Truth Used:
As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic studies is not directly applicable here. The evidence for the device's performance appears to be based on:
- In-vitro testing: Implied by the statement "ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor..." and "Biocompatibility studies have demonstrated..."
- Clinical experience/literature: Supporting the indications for use in various wound types, likely drawing from evidence related to silver and charcoal dressings.
- Substantial equivalence: The primary "proof" for regulatory clearance is establishing substantial equivalence to legally marketed predicate devices with similar materials and intended use.
8. The Sample Size for the Training Set:
This information is not applicable as this is not an AI/algorithm-based device that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as this is not an AI/algorithm-based device that would require a "training set."
N/A