(119 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 Incision Management System provides surgical incision management via the application of negative pressure wound therapy over an incision site that has been surgically closed with sutures or staples. The system is 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 Prevena Plus Incision Management System consists of: A Prevena Dressing (Prevena Plus Peel & Place Dressing or Prevena Plus Customizable Dressing) and One of the following KCI Negative Pressure Wound Therapy Units: Prevena Plus 125 Therapy Unit*, ActiV.A.C. Therapy Unit, V.A.C. Freedom Therapy Unit, InfoV.A.C. Therapy Unit, V.A.C. ATS Therapy Unit, V.A.C. Ulta Therapy Unit. * The Prevena Plus 125 Therapy Unit is a slightly modified V.A.C.Via Therapy Unit, previously cleared under K132741, that provides continuous negative pressure at -125mmHg only. The V.A.C.Via Therapy Unit serves as a reference device for 510(k) K153199.
This document describes a 510(k) premarket notification for the Prevena Plus Incision Management System. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on showing that the new device is as safe and effective as a previously approved device, often through a comparison of technological characteristics and performance data, rather than extensive clinical trials for new medical devices.
Therefore, the typical acceptance criteria and study design elements you'd find for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not directly applicable in the same way here. This is a conventional medical device submission focused on physical and functional equivalence to an existing device.
Here's an interpretation based on the provided text, addressing your points where possible within the context of a 510(k) submission for a non-AI device:
1. A table of acceptance criteria and the reported device performance
For this 510(k) submission, the "acceptance criteria" revolve around demonstrating the new device performs equivalently to the predicate device in key functional areas. The "reported device performance" is the result of non-clinical bench testing.
| Acceptance Criteria (Equivalence to Predicate/Reference) | Reported Device Performance |
|---|---|
| Negative Pressure Delivery: Maintain negative pressure within specification at -125 mmHg, continuous mode for 7 days, under wet conditions and maximum air leak, across the full length of the dressing. | The average distribution of negative pressure across the full length of the Prevena Plus Customizable Dressing on a simulated wound bed under wet conditions and at maximum air leak demonstrated that the Prevena Plus 125 Therapy Unit and tubing set were able to provide negative pressure within specification at -125 mmHg, continuous mode for 7 days, equivalent to both the predicate and reference therapy units. |
| Alarm Functionality: Provide alarms for leak, blockage, and full canister within specification. | The Prevena Plus 125 Therapy Unit was shown to provide alarms for leak, blockage and full canister within specification when connected to the Prevena Plus Customizable Dressing and tubing set. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a "sample size" in the context of a patient-based test set, as this was a non-clinical bench study. The "test set" consisted of simulated wound beds and the components of the device (Prevena Plus Customizable Dressing, Prevena Plus 125 Therapy Unit, tubing set).
- Data Provenance: The studies were non-clinical tests (bench testing/simulations) conducted to support the substantial equivalence determination. The country of origin is not explicitly stated, but the submission is from KCI USA, Inc. in San Antonio, TX, suggesting the testing was likely conducted in the US or by KCI-affiliated entities. It is prospective in the sense that the testing was performed to support this specific submission.
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)
- Not applicable. As a non-clinical bench study, ground truth in terms of expert clinical assessment is not established in the same way as an AI/ML diagnostic or prognostic device. The "ground truth" for the bench tests would be the established engineering specifications and validation methods for negative pressure delivery and alarm functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a non-clinical bench study testing physical and functional specifications. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., radiology images) by multiple experts.
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 device is a negative pressure wound therapy system, not an AI/ML diagnostic or interpretive device that would involve human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable directly in the AI/ML sense. However, the performance data presented is essentially "standalone" device performance, as it evaluates the device's ability to meet its technical specifications (-125 mmHg pressure, alarm function) without human patient interaction as part of the primary measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" would be the engineering specifications and established validation protocols for negative pressure wound therapy systems. This includes:
- Target negative pressure level (-125 mmHg).
- Duration of therapy (7 days).
- Conditions for testing (simulated wound bed, wet conditions, maximum air leak).
- Functional requirements for alarms (leak, blockage, full canister).
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of 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.