(193 days)
Prescription:
Roosin Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites
OTC:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Roosin Silver Calcium Alginate Dressing/ Roosin Alginate Dressing with Preservative is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which absorbs wound exudate and releases silver 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 alginate material consists of silver that controls bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes. The in vitro test was for one day only, so the user is advised to change the dressing every day for antibacterial preservative use.
The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 60 x 70 mm, 100 mm, 100 mm, 100 mm x 150 mm, and 20 mm x 300 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
The provided text describes a medical device, the Roosin Silver Calcium Alginate Dressing, and its substantial equivalence to a predicate device. However, it does not contain information about a study that establishes acceptance criteria for performance, nor does it detail a study proving the device meets specific acceptance criteria related to efficacy beyond basic antibacterial activity.
The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device (K120181) based on intended use, design, materials, specifications, and performance. The "performance" mentioned primarily refers to bacteriostatic properties of the silver within the dressing and biocompatibility.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy (as would be relevant for an AI/imaging device). It mentions that the device "meets the requirements of its pre-defined acceptance criteria and intended uses" but these criteria are not detailed.
However, it does provide specific performance data for its antibacterial properties against certain pathogens:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Meets requirements per ISO 10993-10 and ISO 10993-11. (Pass/Fail) |
| Sterility | Sterilized by radiation using conditions validated following ISO 11137-2: 2012. (Pass/Fail) |
| Antibacterial Efficacy | >99.99% reduction in bacterial growth (Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes) for 24 hours (tested in vitro following AATCC 100-2004). This implies the acceptance criterion was "greater than 99.99% reduction for listed bacteria for 24 hours". |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The antibacterial testing was an in vitro laboratory test, not a clinical study on a patient sample set. The sample size for this test would refer to the number of bacterial cultures or dressing samples tested, which is not specified but is typically much smaller than clinical study sample sizes.
- Data Provenance: The antibacterial activity test was an in vitro laboratory test. The document does not specify the country where this lab testing was performed, but the manufacturer is in China. The study was not a human data study (retrospective or prospective).
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. This device is a medical dressing, not an AI or diagnostic device that requires expert ground truth for interpretation of images or clinical data. The "ground truth" for the antibacterial test would be the observed bacterial growth reduction in the lab, which is a quantitative measurement, not an expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for studies involving human interpretation or consensus, such as in diagnostic imaging.
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
- Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm device. The "standalone" performance here would refer to the dressing's inherent physical and chemical properties and antibacterial function, which were tested in vitro.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For antibacterial efficacy: The ground truth was based on quantitative microbiological measurements of bacterial reduction in a laboratory setting.
- For biocompatibility: The ground truth was based on standardized in vitro and in vivo toxicology tests as per ISO 10993.
- No "expert consensus" or "outcomes data" were used for establishing the primary performance characteristics described.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of the "Study" mentioned:
The document refers to in vitro laboratory testing for evaluating the antibacterial preservative effectiveness of the dressing.
- Methodology: Antibacterial activity was measured following AATCC 100-2004.
- Test Organisms: Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes (Gram positive and Gram negative bacteria).
- Duration of Effect Tested: One day (24 hours).
- Results: The device demonstrated effectiveness (>99.99% reduction) for all six tested bacteria.
- Comparison: These results were deemed comparable to the predicate device when used for preservative purposes and changed at 24-hour intervals.
- Key missing information: The exact number of dressing samples or bacterial replicates tested in this AATCC 100-2004 study is not provided in this summary. There were no human subjects or clinical data in this study; it was an in vitro (laboratory bench) study.
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