(158 days)
Under the supervision of a healthcare professional, KerraCel® Ag may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.
KerraCel® Ag is a soft, sterile, nonwoven dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/ cm (1.7 wt/wt%)). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against gram positive and negative bacteria. KerraCel® Ag absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. KerraCel® Ag meets endotoxin limit specifications.
This document is a 510(k) summary for a medical device called KerraCel® Ag Gelling Fiber Silver Dressing. It does not describe an AI medical device. Therefore, much of the requested information regarding AI-specific studies and ground truth methodologies is not applicable.
However, I can extract information related to the device's performance based on the provided text.
Here's a summary of the acceptance criteria (implied by the comparative testing) and reported device performance for KerraCel® Ag, along with other applicable information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in this document. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device (Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing - K080383) and a reference device (Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber - K121275). Therefore, the "acceptance criteria" can be inferred as "comparable to" or "no significant difference from" the predicate and reference devices.
| Acceptance Criteria (Implied) | Reported Device Performance (KerraCel® Ag) |
|---|---|
| Silver Content: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Moisture Content: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Absorbency: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. The absorbent properties are stated as "similar to K080383" and "more comparable to K121275." |
| Antibacterial Effectiveness: Comparable to predicate/reference devices. | Demonstrated an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against gram positive and negative bacteria (similar to the predicate which also features silver for antibacterial properties). |
| Tensile Strength (wet & dry): Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Gel Assessment: Comparable to predicate/reference devices. | Creates a "soft cohesive gel" that "intimately conforms to the wound surface and maintains a moist wound healing environment," similar to the predicate. |
| Wet out: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Shrinkage: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Lateral Wicking: Comparable to predicate/reference devices. | Evaluated in comparison to predicate/reference. (Specific values not provided but implied to be acceptable for substantial equivalence). |
| Biocompatibility: Safe for intended use as per ISO 10993-1:2009. | Demonstrated to be safe for its intended use. No new safety concerns relative to biocompatibility. Evaluated for Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, and Implantation. |
| Porcine Wound Healing Study (Silver Cytotoxicity): Comparable wound healing to predicate. | No treatment-related abnormal clinical findings. Mean time to complete healing was comparable to Aquacel® Ag-treated wounds. Wound areas were similar with no significant differences. Histopathology evaluation showed total healing scores similar to the predicate device. |
| Endotoxin limit: Meets specifications. | KerraCel® Ag meets endotoxin limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Performance Tests: The sample sizes for each specific bench test (Silver Content, Moisture Content, Absorbency, etc.) are not specified in this document.
- Biocompatibility Testing: The number of samples tested for each biocompatibility test (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation) is not specified.
- Porcine Wound Healing Study:
- Sample Size: Six pigs were involved, with eight 2x2 cm full-thickness wounds created per animal (totaling 48 wounds).
- Data Provenance: The study was a "Pre-Clinical Study" conducted on porcine models. The country of origin is not explicitly stated. The study design is prospective as it involves active treatment and follow-up.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given this is a 510(k) for a wound dressing, not an AI device, there were no "experts" establishing ground truth in the context of diagnostic interpretation.
- In the porcine wound healing study, the evaluation included "Histopathology evaluation." This would typically involve veterinary pathologists. Their specific number and qualifications are not stated.
4. Adjudication Method for the Test Set
Not applicable for device performance and animal studies in this context. Adjudication methods are typically relevant for human clinical trials or expert review of diagnostic results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is not an AI medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical wound dressing, not an algorithm.
7. The Type of Ground Truth Used
- Bench Performance Tests: The "ground truth" for these tests would be the measured physical and chemical properties themselves, using standardized testing methods.
- Biocompatibility Testing: The "ground truth" is established through adherence to recognized international standards (e.g., ISO 10993-1:2009 for biocompatibility) and the specific endpoint measurements of each test (e.g., cytotoxicity assays, irritation scores).
- Porcine Wound Healing Study:
- Clinical Findings: Direct observation of the wounds by study personnel.
- Planimetric Analysis: Measurement of wound area.
- Histopathology Evaluation: Microscopic examination of tissue samples by trained pathologists, providing a "ground truth" on tissue response and healing at a cellular level.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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