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510(k) Data Aggregation
(117 days)
Sorbact Wound Dressing-Ribbon Gauze
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):
| Acceptance Criteria Category | Description of Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Modifications/Equivalency | Intended use, device description, wound contact material, instructions for use, mechanism of action, storage conditions, and shelf life must remain the same as the predicate device despite the color additive change. | Stated that all these characteristics are "the same as that of the predicate device." |
| Functional Performance | Device must continue to meet functional performance requirements after the modification. | "The results of nonclinical testing demonstrate that the device met all performance requirements." |
| Safety (Biocompatibility) | Device must be biocompatible with the new color additive. | "Testing was performed on representative samples of the devices and included the following tests: Cytotoxicity, Intracutaneous reactivity, Sensitization, Systemic toxicity (acute)." Results are stated to have met requirements. |
| Safety (Extractables) | Evaluation of extractable colorants to ensure no harmful substances are released. | "Evaluation of extractable colorants" was performed. Results are implied to be acceptable based on overall conclusion. |
Missing Information (as per your prompt's format, because it's not an AI/ML device):
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Safety and material testing, not clinical diagnosis.
- The sample size for the training set: Not applicable. No AI/ML training set.
- 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.
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