(28 days)
Enluxtra Humifiber™ Wound Dressings are intended as an effective barrier to reduce microbial penetration through the dressing. The Enluxtra Humifiber™ Wound Dressings are for use under healthcare professional's orders for the management of exuding wounds, partial and full thickness wounds, such as pressure ulcers (Stages II-IV), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds.
Enluxtra™ Humifiber™ Wound Dressings are soft non-woven fiber based wound care devices that are designed for use on exuding wounds and as effective barriers to reduce microbial penetration through the dressing.
Enluxtra™ Humifiber™ Wound Dressings are made of synthetic polymers, consisting of a hydrophilic gelling fiber core enclosed between a wound contact fiber layer and backing film. When the dressing is in contact with breached skin/wound and absorbs wound exudate, the polymer fibers form a gel. The backing film supports the gel and allows for simple one-piece removal of the dressing from the wound.
The film prevents fluid strike-through and serves as a microbial barrier to reduce microbial penetration through the dressing.
The Enluxtra™ Humifiber™ Wound Dressings are provided as sterile, single use, disposable devices and will be available in a variety of sizes.
Here's a breakdown of the acceptance criteria and the study information for the Enluxtra™ Humifiber™ Wound Dressing, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a full clinical study with acceptance criteria for novel performance measures. Therefore, much of the requested information regarding AI/human reader studies, ground truth establishment for training sets, etc., is not present as it is not relevant to this type of submission for a wound dressing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Results) |
|---|---|
| Absorbency | Similar to predicate devices |
| Microbial barrier/strike through | Similar to predicate devices |
| Biocompatibility Tests: | |
| Cytotoxiciity - ISO Agar Diffusion | Non-Toxic/Passed |
| Intracutaneous (Intradermal) Reactivity | Non-irritant/Passed |
| Maximization Test for Delayed-Type Hypersensitivity | Negative for evidence of sensitization |
| Acute Systemic Toxicity | Non-Toxic/Passed |
| Hemolysis Test – Extraction and Direct contact Methods | Non-Hemolytic |
| Bacterial Mutagenicity | Not mutagenic |
Study Information
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Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each test. It generally states that "All necessary verification and validation tests have been performed." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified. These are typically bench and laboratory tests, not human subject studies in the context of device performance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for these performance tests (e.g., cytotoxicity, absorbency) is established through standardized laboratory procedures and protocols, not through expert consensus on medical images or clinical outcomes. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies involving human interpretation or subjective assessments. The tests described are objective, laboratory-based measures. -
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. This device is a wound dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant and was not conducted. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. As stated above, this is a physical medical device (wound dressing), not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the biocompatibility tests, the ground truth is based on the results of standardized laboratory assays (e.g., ISO Agar Diffusion for cytotoxicity, Maximization Test for hypersensitivity) which yield objective measurements and classifications (e.g., "Non-Toxic," "Non-irritant," "Negative"). For absorbency and microbial barrier tests, the ground truth would be based on physical and microbiological test standards. -
The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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