(400 days)
Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.
Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination.
The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".
This premarket notification (K050086) for Brennen Medical, Inc.'s Silver Glucan Wound Dressing does not contain detailed acceptance criteria or a dedicated study report proving the device meets specific performance metrics in the way modern medical device submissions typically do for AI/ML devices.
Instead, this 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use, and presents a list of general performance tests conducted. The "acceptance criteria" here are implied by the successful completion of these tests and the determination of substantial equivalence (rather than specific quantitative thresholds).
Therefore, I will extract the information available and note where specific details are not provided in this document format.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance(s) |
|---|---|---|
| Biocompatibility | No adverse tissue reactions (irritation, sensitization, cytotoxicity). | Studies conducted: skin irritation, sensitization, and cytotoxicity. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. |
| Wound Healing | Supports or does not impede wound healing. | Animal Wound Healing Study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. |
| Silver Dissolution | Controlled and appropriate release of silver ions. | Silver dissolution study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. |
| Tensile Strength | Sufficient mechanical integrity for intended use. | Tensile strength study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. |
| Barrier Efficacy | Effective barrier to bacterial and candida penetration. | Barrier efficacy study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. The indication for use explicitly states it is "an effective barrier to bacterial and candida penetration." |
| Antimicrobial Activity | Zone of inhibition demonstrating antimicrobial effect. | Zone of inhibition study conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. |
| Stability | Maintains integrity and performance over shelf life. | Stability testing conducted. Outcome: Device is effective for intended use and functions in a substantially equivalent manner. |
| Substantial Equivalence | Device is as safe and effective as predicate devices. | Reviewed against Acticoat Silver Coated Wound Dressing (K955453) and Silverlon Contact Wound Dressing (K981299), and others. Conclusion: Found substantially equivalent in design, materials, function, intended use, and does not raise new questions of safety or effectiveness. |
Missing Information: Specific quantitative thresholds for "acceptance criteria" (e.g., minimum tensile strength in Newtons, specific cytotoxicity scores, exact zone of inhibition measurements) are not detailed in this summary. The summary broadly states that the device "is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
This 510(k) summary does not describe specific "test sets" in the context of an algorithm or AI model evaluation. The "studies" mentioned (Biocompatability, Animal Wound Healing, Silver Dissolution, Tensile Strength, Barrier Efficacy, Zone of Inhibition, Stability) are laboratory or animal-based performance tests, not clinical evaluations with human patient data or AI algorithm testing with a specific test set.
- Sample Size for Test Set: Not applicable/not specified for a "test set" in the context of an AI/ML device. The underlying details of the sample sizes for each specific performance study (e.g., number of animals in the wound healing study, number of samples for tensile strength) are not provided in this summary.
- Data Provenance: Not applicable/not specified for an AI/ML device test set. The provenance of the data for the performance studies (e.g., which lab conducted the tests, what species for animal studies) is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. This 510(k) pertains to a wound dressing, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth on a test set. The listed studies are laboratory and preclinical performance tests.
4. Adjudication Method for the Test Set
This information is not applicable. There is no AI/ML test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an imaging or diagnostic AI/ML system that would typically undergo such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies refers to the direct measurement or observation of the physical, chemical, or biological properties and effects of the wound dressing.
- Biocompatibility: In-vitro (cytotoxicity, sensitization assays) and in-vivo (irritation, sensitization on animals/humans) test results.
- Wound Healing: Clinical and histological assessment of wound closure, tissue regeneration, inflammation in an animal model.
- Silver Dissolution: Analytical chemistry measurements of silver release.
- Tensile Strength: Physical testing measurements of material strength.
- Barrier Efficacy: Microbiological challenge tests demonstrating reduction of bacterial/fungal penetration.
- Zone of Inhibition: Microbiological growth assays on agar plates.
- Stability Testing: Comparison of pre- and post-aging performance characteristics.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that is "trained."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm that is "trained."
N/A