(86 days)
DURAFIBER Ag is an effective antimicrobial dressing that is intended to provide a moist wound environment for use in the management of partial and full thickness wounds including first and second degree burns. Appropriate wounds types include:
- Chronic wounds including diabetic ulcers, leg ulcers, pressure ulcers and sores (partial & full thickness);
- surgical wounds left to heal by secondary intent;
- traumatic wounds:
- wounds that are prone to minor bleeding, such as wounds that have been mechanically or surgically debrided.
DURAFIBER Ag is a non-woven dressing made of cellulose and cellulose ethylsulphonate with silver. The product is an absorbent fibrous dressing that gels on contact with wound fluid. The silver provides the antimicrobial properties intended to reduce or inhibit microbial colonization of the device.
The silver is present in the device in the form of silver chloride. Upon contact with wound fluid, silver ions are produced from the dissociation of silver and chloride atoms. The ionic form of silver is the active antimicrobial agent.
This is a 510(k) premarket notification for the medical device DURAFIBER Ag, an antimicrobial wound dressing. The document describes the device, its intended use, and a comparison to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting study information:
Description of Acceptance Criteria and Supporting Study
The provided document, a 510(k) summary, does not detail specific acceptance criteria for a new AI/software device or a formal clinical study proving its performance against such criteria. Instead, this document is focused on establishing substantial equivalence for a modified physical medical device (a wound dressing) to a previously cleared predicate device.
The "acceptance criteria" here are implicitly related to demonstrating that changes to the device (specifically, reduced silver content) do not negatively impact its safety and effectiveness compared to the predicate. The "study" in this context refers to non-clinical bench testing rather than a clinical trial with a test set, ground truth, or human readers as you would expect for an AI/software device.
Therefore, many of your specific questions are not directly applicable to this type of regulatory submission and device.
However, I will extract the information that is present and indicate where information is not applicable or not provided.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a submission for a modified physical wound dressing and not an AI/software device, formal acceptance criteria in terms of metrics like sensitivity, specificity, or AUC are not specified. The "performance" is demonstrated through non-clinical bench testing to ensure the modified device remains equivalent to its predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Physical Properties remain unchanged despite reduced silver content (compared to predicate). | "Results showed that the reduced silver content of the dressing did not alter the physical properties of the dressing." |
| Silver Release (although different, the change is characterized) | "Results showed that the subject device released a lower amount of silver over a seven day test period compared to the predicate device." (This is a description of the change, not necessarily an "acceptance criterion" in the sense of a target value, but rather a characterization supporting equivalence). |
| Antimicrobial Properties remain unchanged despite reduced silver content (compared to predicate). | "Results showed that the reduced silver content of the subject device did not alter the antimicrobial properties of the dressing." |
| Biocompatibility for intended use. | "DURAFIBER Ag has been evaluated in accordance with ISO 10993-1 and is considered safe for its intended use." |
| Safety and Effectiveness not raising new issues (compared to predicate). | "The subject device does not raise any new issues of safety and effectiveness." (This is the overarching conclusion drawn from the physical, silver release, and microbiology testing, along with the identical design, materials, manufacturing, and indications for use as the predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The "tests" were non-clinical bench tests (physical properties, silver release, microbiology, biocompatibility) of the device itself and not based on patient data or a "test set" in the context of an AI/software algorithm.
- Data Provenance: Not applicable. The data is from laboratory bench testing rather than clinical data.
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. There was no "ground truth" derived from expert consensus for a test set, as this involved laboratory testing of a physical product, not an AI/software diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for the non-clinical tests was determined by established laboratory measurement methods and standards relevant to the physical and antimicrobial properties of wound dressings (e.g., standard tests for material properties, silver elution, and bacterial inhibition).
8. The sample size for the training set
Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study (Bench Testing) for DURAFIBER Ag Modification
The "study" presented here consists of non-clinical, bench-top testing to demonstrate that a modified version of the DURAFIBER Ag wound dressing (with reduced silver content) is substantially equivalent to its predicate device. This was achieved by confirming:
- The physical properties of the dressing were not altered.
- The silver release profile, while different (lower amount released), was characterized.
- The antimicrobial properties were not altered despite the reduced silver content.
- The device met biocompatibility standards (ISO 10993-1).
The conclusion is that these tests collectively demonstrate that the modified device does not raise new questions of safety and effectiveness, supporting its substantial equivalence to the previously cleared predicate.
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