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The PREVENA PLUS 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.

The PREVENA PLUS DUO 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.

The PREVENA PLUS 125 Unit is a component of a the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a maximum of fourteen (14) days depending on the surgeon's preference.

The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination.

The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the therapy unit.

This document does not contain an acceptance criteria table or a detailed study proving the device meets specific acceptance criteria in the manner typically seen for algorithmic performance (e.g., sensitivity, specificity, AUC). Instead, it's a 510(k) submission for a medical device (a Negative Pressure Wound Therapy system) that focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical bench testing.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or estimable from the provided text for an AI/algorithm-based device.

Here's an attempt to answer the questions based only on the provided document:

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

Based on the document, the primary "acceptance criterion" for this 510(k) submission is the demonstration of substantial equivalence to a predicate device, specifically regarding the sustained delivery of negative pressure.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document states that "Bench testing demonstrated..." but does not detail the sample size (number of units tested, number of test runs) or data provenance. Since it's bench testing, it's not human data and thus retrospective/prospective or country of origin isn't directly applicable in the same way as for clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth for bench testing typically involves engineering specifications and measurements against those specifications, not expert human assessment.

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

This information is not applicable/provided. Adjudication methods are relevant for human expert review processes, which are not described for this bench testing.

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

This information is not applicable/provided. No MRMC study was conducted, as this is a physical medical device (negative pressure wound therapy unit), not an AI algorithm assisting human readers. The document explicitly states: "No clinical tests were necessary." and "No usability testing was required, as there has been no change to the user interface or to the Instructions for Use."

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

This information is not applicable/provided. This is a physical device, not an algorithm. The performance described is the standalone performance of the device itself (its ability to maintain negative pressure).

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

The ground truth for the bench testing would be the engineering specifications and established physical principles for continuous negative pressure delivery at -125 mmHg, as determined by internal R&D and quality standards. Specific details are not provided, but it's fundamentally based on measured physical parameters against design requirements.

8. The sample size for the training set

This information is not applicable/provided. This is not an AI/machine learning device that uses a "training set."

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

This information is not applicable/provided. This is not an AI/machine learning device.

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The PREVENA PLUS 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. The PREVENA PLUS DUO 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.

The negative pressure technology for the subject device systems is the same as that for the predicate device systems. The PREVENA PLUS 125 Therapy Unit is a component of the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the therapy unit.

The provided text is a 510(k) Summary for the PREVENA PLUS Incision Management System and PREVENA PLUS DUO Incision Management System. It details an FDA submission for substantial equivalence.

Based on the provided information, there are no acceptance criteria or studies proving device performance in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC, human reader improvement with AI assistance).

This document describes a medical device related to negative pressure wound therapy and its equivalence to predicate devices, not an AI/ML powered device. The "Performance Data" section specifically states:

• "Bench testing demonstrated that the PREVENA PLUS 125 Therapy Unit is able to deliver continuous negative pressure at 125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 7 day test. Alarms for blockage, leakage and full canister were tested with both the PREVENA PLUS and the PREVENA PLUS DUO Systems and met specifications."
• "Electrical safety and electromechanical emissions testing confirm that the subject therapy unit meets the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 ... IEC 60601-1-2 ... IEC 60601-6 ... IEC 60601-1-8 ... IEC 60601-1-11."
• "The new lithium battery has been verified to meet IEC 62133 Edition 2.0 2012-12."
• "No clinical tests were necessary. No usability testing was required, as there has been no change to the user interface or to the Instructions for Use."

This indicates performance criteria related to mechanical function, electrical safety, and alarm systems of a physical medical device, not analytical or clinical performance of an AI model.

Therefore, I cannot provide the requested information regarding AI/ML performance criteria and studies.

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