(188 days)
Advanced Medical Solutions Ltd's Antimicrobial Alginate. Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.
Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal. The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.
This document describes the 510(k) summary for Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance metrics (accuracy, sensitivity, specificity, AUC), or details of a study with sample sizes, ground truth establishment, or expert qualifications for performance evaluation.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K002896 Acticoat Calcium Alginate Dressing) based on similarities in:
- Materials (calcium alginate and silver)
- Intended use and indications for use
- Product description and functional characteristics (absorbent, sterile, sustained silver release, antimicrobial effect, barrier to bacterial penetration, maintains moist wound environment, intact removal, similar dressing change frequency)
- Biocompatibility (demonstrated in accordance with BSENISO 10993-1)
- Sterilization method (gamma irradiation)
- Contraindications
- Product sizes and variants
The document states: "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." However, it does not provide specific performance metrics or detailed results from this in vitro testing, nor does it detail a clinical study with the requested elements.
Therefore, I cannot populate the table or answer most of the questions as the provided text does not contain that specific information.
Summary of available information regarding performance and studies:
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A table of acceptance criteria and the reported device performance:
Not provided in the document. The document focuses on demonstrating substantial equivalence rather than reporting specific performance metrics against set acceptance criteria for metrics like accuracy, sensitivity, specificity, or AUC. -
Sample size used for the test set and the data provenance:
Not provided. The document mentions "Additional in vitro testing" but does not detail sample sizes or data provenance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no human-in-the-loop study with a test set requiring expert ground truth is described. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. -
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:
Not applicable. This device is an antimicrobial dressing, not an AI-assisted diagnostic tool. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document mentions "Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device." This suggests some form of standalone testing was performed to compare its characteristics to the predicate, but no specific performance metrics like those for an algorithm are detailed. The device is a physical dressing, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly stated for the "in vitro testing." Given the nature of an antimicrobial dressing, ground truth would likely relate to microbiological growth inhibition, fluid absorption, or silver release rates, rather than expert consensus on images or pathology. -
The sample size for the training set:
Not applicable, as this is not an AI/ML device with a training set in the conventional sense. -
How the ground truth for the training set was established:
Not applicable.
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