(80 days)
The 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
- . Leq Ulcers
- Pressure Ulcers .
- Diabetic Ulcers .
- Graft and donor sites .
Silver Alginate II Dressing is indicated for external use only
The dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver, which absorbs wound exudate and releases silver ions in the presence of wound fluid. As wound exudate 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 four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing.
The dressing is an effective barrier to penetration by microorganisms.
The dressing has a off-white appearance, and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm flat dressings; 2.7cm x 30cm, and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat dressings are packaged in pouches, and the flat rope and rope dressings are packaged in a blister pack.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Silver Alginate II Dressing.
This submission is a 510(k) for a medical device (wound dressing), which primarily demonstrates substantial equivalence to existing predicate devices rather than proving a novel therapeutic effect or clinical outcome through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the new device performs similarly to or meets the established characteristics of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Biocompatibility (per BS EN ISO 10993-1) | "The biocompatibility of Advanced Medical Solutions Ltd's Silver Alginate II Dressing has been demonstrated in accordance with BS EN ISO 10993-1 requirements." |
| Absorbency | "Comparable absorbency... have been demonstrated." (Implied to be comparable to predicate devices Acticoat® Calcium Alginate Dressing and Absorbent Antimicrobial Wound Dressing) |
| Silver Release Profile | "Comparable... silver release profile... have been demonstrated." (Implied to be comparable to predicate devices Acticoat® Calcium Alginate Dressing and Absorbent Antimicrobial Wound Dressing) |
| Antimicrobial Activity | "Comparable... antimicrobial activity have been demonstrated." (Implied to be comparable to predicate devices Acticoat® Calcium Alginate Dressing and Absorbent Antimicrobial Wound Dressing). |
| Additionally, "The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to four (4) days, based on in vitro laboratory testing. Odour reduction results from the antibacterial effect in the dressing." | |
| Protection from Microorganism Penetration | "The dressing is an effective barrier to penetration by microorganisms." |
| Maintenance of Moist Environment for Healing | "As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing." |
| Intact Removal | "allows intact removal." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for any of the in vitro tests. The data provenance is stated as "in vitro laboratory testing" conducted by Advanced Medical Solutions Ltd. (England). This indicates the data is from an in vitro (laboratory) setting and not from human clinical trials. It is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence of a wound dressing is based on established performance characteristics and standardized in vitro testing methods (e.g., ISO standards, antimicrobial efficacy tests). It does not involve expert consensus on the device's performance in a clinical scenario, as would be the case for a diagnostic AI device.
4. Adjudication Method for the Test Set
This is not applicable. The "adjudication method" refers to how discrepancies in expert opinions are resolved, typically in a clinical study context. Since the testing described is in vitro and based on measurable performance characteristics, there is no expert adjudication process in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Silver Alginate II Dressing is a therapeutic wound dressing, and its performance is evaluated through in vitro tests and comparison to predicate devices, not by human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the Silver Alginate II Dressing is a physical medical device (wound dressing), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" doesn't apply.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by:
- Established performance characteristics of predicate devices: The new device's performance (absorbency, silver release, antimicrobial activity) is compared to that of the already legally marketed predicate devices.
- Standardized in vitro testing methodologies: Biocompatibility is assessed against BS EN ISO 10993-1 requirements. Antimicrobial activity and other key performance characteristics would have been evaluated using recognized laboratory methods.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this 510(k) submission for a wound dressing. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
N/A