(328 days)
OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding) and to attract water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns.
Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to low exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
Sorbact® gel Wound Dressings are sterile bandages that attract and capture water-repelling (hydrophobic) microorganisms.
The provided 510(k) summary for the Sorbact® Gel Wound Dressing (K100591) does not contain information about a study proving the device meets specific acceptance criteria in the manner typically described for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth). Instead, the summary focuses on demonstrating substantial equivalence to a predicate device.
Therefore, many of the requested elements for a detailed study description are not applicable or cannot be extracted from this document. However, I can provide the available information based on the content.
Here's an analysis of the "acceptance criteria" and the "study" as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly based on demonstrating that the new device, Sorbact® gel, performs equivalently to the predicate device, Sorbact® Wound Dressing, in its ability to bind hydrophobic microorganisms, and also passes standard biocompatibility tests.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Microbial Binding Ability (Hydrophobic Microbes/Germs) | "Results of the test were identical for both devices." (Sorbact gel vs. original Sorbact wound dressing) |
| Biocompatibility - Skin Sensitization | "Sorbact gel passed all tests." |
| Biocompatibility - Cytotoxicity | "Sorbact gel passed all tests." |
| Biocompatibility - Skin Irritation | "Sorbact gel passed all tests." |
| Technological Characteristics (with hydrogel addition) | Allows effective management of low exuding dry wounds and creates a moist wound healing environment. (This is a design modification, not a performance metric for comparison) |
| Intended Use | "Sorbact gel has identical... intended use as the original Sorbact wound dressing." |
| Overall Predicate Equivalence Conclusion (FDA) | The FDA determined the device is substantially equivalent (for the indications for use stated). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the comparative microbial binding test. For biocompatibility, the number of samples/subjects is not mentioned, but these are typically standardized in vitro or in vivo tests.
- Data Provenance: Not specified. Standard biocompatibility tests follow international guidelines (e.g., ISO 10993). The microbial binding test is a comparative test performed by the manufacturer. Whether it involved human data, animal data, or in vitro models, or its geographic origin, is not stated.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not applicable. This study does not involve establishing ground truth from expert readings for image analysis or diagnostic performance, as it is a wound dressing. The "ground truth" for microbial binding is the performance of the predicate device. For biocompatibility, it's adherence to established safety standards.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of an adjudication method, as it's not a reader study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is not an MRMC study. It is a comparison of a modified medical device to its predicate.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable, as this is not an AI/ML device. The performance claimed is for the device's inherent physical and chemical properties (microbial binding, biocompatibility), not an algorithm.
7. The Type of Ground Truth Used
- Comparative Performance: For microbial binding, the "ground truth" was established by the performance of the legally marketed predicate device, Sorbact® Wound Dressing, in the identical test ("Results of the test were identical for both devices.").
- Safety Standards: For biocompatibility (Skin Sensitization, Cytotoxicity, Skin Irritation), the ground truth is implicitly defined by the pass/fail criteria of recognized international standards (e.g., ISO 10993 series for biological evaluation of medical devices).
8. The Sample Size for the Training Set
- Not applicable. This device does not use a training set in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device does not use a training set in the context of AI/ML.
In summary, this 510(k) pertains to a wound dressing and demonstrates substantial equivalence through direct comparison of a specific performance characteristic (microbial binding) and adherence to general safety standards (biocompatibility). It does not involve complex clinical studies or AI/ML performance evaluations typically associated with the detailed questions on acceptance criteria for diagnostic devices.
N/A