(3 days)
Silver Alginate II 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
- Pressure ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- 1st and 2nd degree burns
- Partial and full thickness wounds
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 fourteen (14) 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.
Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing.
The Silver Alginate II Dressing is available various sizes: 5cm x 5cm (2" x 2"), 10cm x 10cm (4" x 4"). 10cm x 12cm (4" x 4.75"). 15cm x 15cm (6" x 6"). 10cm x 20cm (4" x 8"), 20cm x 30cm (8" x 12") and 2.7cm x 30cm (1" x 12"). The dressings are packaged in foil pouches.
This document describes a Special 510(k) Device Modification for the Advanced Medical Solutions Limited's Silver Alginate II Dressing. The modification aims to demonstrate substantial equivalence to previously cleared devices. The document references performance data but does not explicitly state acceptance criteria or the specifics of a study proving the device meets those criteria in a way that aligns with the detailed requests in the prompt.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics or thresholds. | - Antimicrobial effectiveness: "The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to fourteen (14) 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." |
| - Biocompatibility: "demonstrated to be in compliance with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices)." | |
| - Sterilization: "Sterilisation validation has been performed in compliance with ISO 11137 standards." | |
| - Overall: "The biocompatibility testing, in-vitro performance testing and microbiological assessment for the Silver Alginate II Dressing has demonstrated that the device is safe and effective for the indications of use." | |
| - Substantial Equivalence: "The indication for use, performance testing and antimicrobial activity for the Silver Alginate II Dressing is substantially equivalent to the predicate devices; Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions." |
2. Sample size used for the test set and the data provenance
The document mentions "in-vitro testing" and "microbiological assessment" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests described are laboratory/bench tests, not involving expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. The tests described are laboratory/bench tests, not involving adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document refers to in-vitro testing and biocompatibility assessments, not studies involving human readers and clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a wound dressing, not an AI algorithm. The performance described is for the physical device itself.
7. The type of ground truth used
For antimicrobial effectiveness, the ground truth appears to be based on direct observation of bacterial inhibition/reduction in in-vitro settings.
For biocompatibility, the ground truth is compliance with the requirements of international standard BS EN ISO 10993-1, which involves various biological tests.
For sterilization, the ground truth is compliance with ISO 11137 standards, which involves validated sterilization processes.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based device.
N/A