Search Results

The PREVENA PLUS Incision Management System (No Ag) is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate via the application of negative pressure wound therapy.

The PREVENA PLUS DUO Incision Management System (No Ag) 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. The system consists of a therapy unit (PREVENA PLUS™ 125 Therapy Unit, ACTIVAC™ Therapy Unit, V.A.C. ULTA™ Therapy Unit, or V.A.C. RX4™ Therapy Unit), dressing and canister. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. Application of negative pressure wound therapy to an incision site that is closed via staples or sutures helps draw the incision edges together and remove fluid from the incision site into a canister fitted to the therapy unit. The occlusive drape of the dressing provides a negative pressure environment and protects the incision from external contamination. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference.

The provided document is a 510(k) premarket notification for the PREVENA PLUS Incision Management System (No Ag) and PREVENA PLUS DUO Incision Management System (No Ag). This document, while detailing the process of seeking FDA clearance for a medical device, does not contain the acceptance criteria or a study proving the device meets those criteria in the typical format of an AI/ML-based diagnostic device.

The device described is a negative pressure wound therapy system, a physical medical device, not a software or AI-driven diagnostic tool that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Therefore, the questions related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "ground truth establishment for training set") are not applicable to the information provided in this document.

The acceptance criteria in this context are related to the safety, efficacy, and conformance to design specifications of the physical device, and its substantial equivalence to a predicate device.

However, I can extract the relevant information from the document regarding the device's validation:

1. Table of acceptance criteria and reported device performance:

Note: The document states "Conclusions drawn: The PREVENA PLUS Incision Management System (No Ag) and PREVENA PLUS DUO Incision Managements Systems (No Ag) are substantially equivalent to the predicate device systems with respect to indications for use and technology." This "substantial equivalence" is the primary acceptance criterion for 510(k) clearance, rather than specific performance metrics against a defined "ground truth" as seen in AI/ML diagnostic tools.

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

• The document does not specify sample sizes for the system performance, biocompatibility, or material equivalency tests.
• Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These are typically in a detailed study report, not the 510(k) summary.

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

• This is not applicable as the studies conducted are engineering and biocompatibility tests on a physical device, not diagnostic performance evaluations requiring expert review against a ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable for the types of tests described.

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. This is a physical medical device, not an AI-based diagnostic tool that assists human readers.

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

• Not applicable. This is a physical medical device.

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

• For "System Performance Testing," the ground truth would be the device's design specifications for negative pressure delivery, fluid removal, etc.
• For "Biocompatibility testing," the ground truth would be established by ISO 10993-1 standards (e.g., absence of cytotoxicity, irritation, sensitization).
• For "Material specification equivalency testing with respect to Horizontal Wicking performance," the ground truth would be the performance of the predicate device and established material specifications for wicking.
• No "expert consensus," "pathology," or "outcomes data" in the typical sense of diagnostic ground truth is mentioned for these engineering/material tests.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires training data.

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

• Not applicable.

Ask a specific question about this device