Search Results

The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Negative pressure wound therapy system for application to surgically closed incisions.

This K133232 510(k) summary describes the Prevena Incision Management System, a negative pressure wound therapy device.

Here's an analysis of the provided text regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain explicit acceptance criteria or a direct table comparing them to reported device performance. This 510(k) is a submission for a labeling change for an existing device, and it relies on substantial equivalence to previously cleared predicate devices (K123878 and K100821). The submission states: "There have been no technological changes to the predicate device for the purpose of the proposed labeling change."

Instead of performance criteria, the document asserts:

• "The Prevena Incision Management System and its predicate are substantially equivalent in terms of safety, function and indications for use."
• "The safety and effectiveness of the Prevena Incision Management System is adequately supported by the substantial equivalent information and data provided in this Premarket Notification."

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. No new clinical or non-clinical tests were performed for this particular 510(k) submission.
• Data Provenance: The document states that KCI conducted a systematic literature review of studies involving the Prevena Incision Management System and is adding a bibliography of published studies to the labeling. This suggests the data provenance is from retrospective, published clinical studies potentially from various countries, but specific details on the countries of origin are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was created for this submission. The systematic literature review might have reviewed studies where expert consensus was used, but this is not detailed in the provided text.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No new test set required adjudication for this submission.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device in question is a medical device (Negative Pressure Wound Therapy System), not an AI diagnostic tool that would involve human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance Study: No. This is not an AI algorithm. It's a medical device that provides negative pressure wound therapy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the systematic literature review, the "ground truth" would implicitly refer to the outcomes reported in the published clinical studies. These outcomes would likely include measures relevant to wound healing, infection rates, drainage management, and patient safety, which are typically derived from clinical observation, patient records, and potentially pathology reports depending on the specific study designs. The document states the system "is intended to manage the environment of surgical incisions that continue to drain... by maintaining a closed environment and removing exudate," implying ground truth would relate to these aspects.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document pertains to a resubmission for a labeling change for an existing medical device, not a new device requiring a training set or an AI algorithm.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable.

Ask a specific question about this device