(134 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 .
- Pressures 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 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. Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing. 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 510(k) premarket notification for a medical device called "Silver Alginate II Dressing." This submission is for a device modification and asserts substantial equivalence to previously cleared devices.
The information provided does not include a study that focuses on device performance in the context of acceptance criteria as one would typically find for an AI/ML medical device. Instead, the document discusses the biocompatibility and sterilization validation of the dressing, and its substantial equivalence to predicate devices based on comparable absorbency, silver release profile, and antimicrobial activity. There is no mention of an algorithm, AI, machine learning, or human reader studies.
Therefore, the requested information elements related to AI/ML device performance and associated studies (items 1 through 9) are not present in the provided text.
Here is a summary of what is available in the document, which primarily focuses on regulatory approval based on equivalence for a wound dressing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit - based on predicate device equivalence):
- Biocompatibility in compliance with BS EN ISO 10993-1.
- Sterilization validation in compliance with harmonized standards.
- Comparable absorbency to predicate devices.
- Comparable silver release profile to predicate devices.
- Comparable antimicrobial activity to predicate devices.
- Reported Device Performance:
- "The biocompatibility of Advanced Medical Solutions Limited Silver Alginate II Dressing has been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1."
- "Sterilisation validation has been performed in compliance with harmonised standards."
- "Comparable absorbency, silver release profile and antimicrobial activity have been demonstrated."
- "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."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* This information is not provided in the document. The studies mentioned (biocompatibility, sterilization, absorbency, silver release, antimicrobial activity) are general test types for wound dressings, but specific sample sizes or data provenance are not detailed.
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)
* Not applicable as no expert-based ground truth for a test set (like an image review or clinical outcome assessment) is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable.
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
* No MRMC study was done, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For biocompatibility and sterilization, the "ground truth" would be compliance with specified international standards (BS EN ISO 10993-1 and unspecified harmonized standards for sterilization).
* For absorbency, silver release, and antimicrobial activity, the "ground truth" was established through in-vitro laboratory testing, with comparison to predicate devices. The specifics of these tests (e.g., control groups, reference methods) are not detailed but are implied to be standard in-vitro assessments for such dressings.
8. The sample size for the training set
* Not applicable, as this is not an AI/ML device and no training set is described.
9. How the ground truth for the training set was established
* Not applicable, as this is not an AI/ML device and no training set is described.
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