Search Results

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.

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.

Ask a specific question about this device

Rx: Sorbact® Wound Dressings are intended for use in the management of moderate to heavily exudating partial to full thickness wounds (including clean, colonized, contaminated or infected wounds) and to bind hydrophobic microbes The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
OTC: Sorbact® Wound Dressings are intended for use in the management of draining minor wounds and to attract and bind water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns.

Sorbact Wound Dressings are sterile bandages that attract and capture water-repelling (hydrophobic) microorganisms. The dressings are coated with DACC (dialky) carbamoyl chloride), a hydrophobic (water-repelling) fatty ester acid that binds to and reduces the overall concentration of hydrophobic microbes in a wound each time the dressing is changed. Available Sorbact products include adsorbent dressings, compresses, ribbon gauze tamponades, round swabs and surgical dressings.

The provided text describes the Sorbact® Wound Dressing and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or detailed study results that prove the device meets specific acceptance criteria.

The document states:

• "Sorbact® wound dressings have been shown in studies, including in vitro and clinical tests, to be safe and effective for their intended uses." (Page 4, Section V)

However, it lacks the specific data points needed to answer your questions within the context of acceptance criteria and proven performance. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting comprehensive study data with acceptance criteria.

Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text.

Here's a breakdown of what can be inferred from the provided text and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided. The document states that in vitro and clinical tests were conducted to show safety and effectiveness, but it does not specify any quantitative acceptance criteria (e.g., "bacterial reduction must be >X%") or the actual performance metrics achieved in those tests.

2. Sample Size Used for the Test Set and Data Provenance

Cannot be provided. The document mentions "clinical tests" but does not provide any details about the sample size (number of patients/wounds), study design, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Cannot be provided. The document does not describe the establishment of a ground truth for a test set, nor does it mention any expert involvement in such a process. This kind of detail is typically relevant for studies involving subjective assessments (e.g., image-based diagnostics) which is not the primary focus of a wound dressing's efficacy where clinical outcome is key.

4. Adjudication Method for the Test Set

Cannot be provided. As there's no mention of a test set with subjective assessments by experts, there's no description of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Cannot be provided. The document does not describe an MRMC study or any scenario where human readers would improve with or without AI assistance, as this device is a wound dressing, not an AI diagnostic tool.

6. Standalone Algorithm Performance

Cannot be provided. This question is irrelevant as the Sorbact® Wound Dressing is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

Cannot be provided in detail. For a medical device like a wound dressing, the "ground truth" for demonstrating safety and effectiveness would typically be clinical outcomes (e.g., wound healing rates, reduction in infection, absence of adverse events), and potentially microbiological data for its antimicrobial claims. However, the document does not specify how this ground truth was established or measured in the "clinical tests."

8. Sample Size for the Training Set

Cannot be provided. This question is irrelevant as the Sorbact® Wound Dressing is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Cannot be provided. This question is irrelevant for the same reason as point 8.

Ask a specific question about this device