Search Results

Sorbact® Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact® Ribbon Gauze is indicated for shallow cavity wounds and fistulas.

Sorbact® Ribbon Gauze is a sterile (gamma irradiation), single use only, hydrophobic microbe binding wound dressing. It consists of a Sorbact® wound contact layer, which allows passage of wound exudate into a secondary dressing.

Based on the provided text, the device in question is the "Sorbact® Wound Dressing – Ribbon Gauze". However, this document is a 510(k) premarket notification for a modification to an existing device, specifically a change to the color additive. The provided information does not describe a study that uses a test set to prove the device meets performance criteria related to its clinical efficacy or diagnostic performance as an AI/ML device.

The performance data section explicitly states: "The modification addressed by this 510(k) is a change to the color additive in the Sorbact® Ribbon Gauze. As the intended use, device description, wound contact material, instructions for use, mechanism of action, storage conditions, and shelf life of the modified device are the same as that of the predicate device, both devices have the same fundamental scientific technology."

Therefore, the "performance data" presented is entirely focused on non-clinical testing related to the safety and material properties of the new color additive, rather than a clinical performance study involving a test set, ground truth, or human readers, as would be expected for an AI/ML device.

Given this, I cannot fill in the requested table and answer the specific questions (2-9) because the information is not present in the provided document. The document describes a traditional medical device (wound dressing) and a 510(k) submission for a minor change (color additive), not an AI/ML device or its performance evaluation in the context you've outlined.

Here's what I can extract regarding acceptance criteria and performance, as related to the specific modification:

1. Table of Acceptance Criteria and Reported Device Performance (for the color additive change):

Missing Information (as per your prompt's format, because it's not an AI/ML device):

2. Sample sizes used for the test set and data provenance: Not applicable. This was non-clinical material and biocompatibility testing, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Safety and material testing, not clinical diagnosis.
8. The sample size for the training set: Not applicable. No AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a regulatory submission for a minor modification to a non-AI/ML medical device. It does not contain the information required to address your specific questions about AI/ML device performance studies.

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