(60 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input during a 14-day test. | Bench testing demonstrated that the PREVENA PLUS 125 Negative Pressure Wound Therapy Unit is substantially equivalent to the predicate therapy unit in the delivery of continuous negative pressure at -125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 14 day test. |
| Safety, performance, and indications for use being equivalent to the predicate device systems. | The PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System are substantially equivalent to the predicate device systems in terms of safety, performance and indications for use. |
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.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.