(112 days)
Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings.
The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, Prevena Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
The Prevena ™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena Plus Negative Pressure Wound Therapy System), is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The Prevena™ Plus 125 Therapy Unit may be used part of as either of these systems:
A) Prevena Incision Management System Consist of:
- Prevena™ Therapy Unit .
- Prevena 150mL Canister & adaptor .
- Prevena Dressing kit ●
B) Prevena Plus Negative Pressure Wound Therapy System Consist of:
- Prevena™ Plus 125 Therapy Unit .
- Prevena 150mL Canister & adaptor .
- V.A.C. Dressing kit ●
The Prevena™ Plus Incision Management System (Prevena™ Plus Therapy Unit when used with Prevena Dressings) is designed for use over linear, non-linear, intersecting incisions.
The Prevena™ Plus Negative Pressure Wound Therapy System (Prevena™ Plus Therapy Unit when used with V.A.C. Dressings) is designed for use in a variety of open wound types such as: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The Prevena Plus 125 Therapy Units are negative pressure pumps that deliver -125mmHg continuously for up to 7 or 14 days.
The provided text is a 510(k) premarket notification summary for the Prevena Plus 125 Therapy Unit. It describes the device's indications for use, comparison to predicate devices, and performance data. However, it does not include a detailed study proving that the device meets specific acceptance criteria in the way typically required for AI/ML-driven medical devices.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. The performance data presented refers to non-clinical tests and human factors evaluation for a negative pressure wound therapy device, not a diagnostic AI system with performance metrics like sensitivity, specificity, or AUC against a ground truth.
Therefore, many of the requested elements for an AI/ML device study are not applicable or present in this document. I will answer based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a non-AI/ML negative pressure wound therapy device seeking substantial equivalence, "acceptance criteria" and "device performance" are framed differently than for an AI diagnostic algorithm. The document states that the device functions "as intended" and maintains "negative pressure within specifications." Specific quantitative acceptance criteria (e.g., minimum pressure maintained, maximum leakage) are not detailed in this summary, nor are corresponding "reported device performance" values in a comparative table for such criteria.
| Acceptance Criteria (Implicit from device function) | Reported Device Performance (Implicit from study conclusions) |
|---|---|
| Maintain negative pressure within specifications when used with dressings. | "Prevena™ Plus Negative Pressure Wound Therapy System negative pressure test demonstrates the Prevena Plus Therapy Unit when used with small and medium V.A.C. Dressing as part of a system, maintains negative pressure within specifications." |
| Function as intended when used with V.A.C. Dressings. | "In all instances, the Prevena™ Plus 125 Therapy Unit functioned as intended with V.A.C. Dressings and all test results observed were as expected." |
| Be safe and effective for its indicated uses. | The submission concludes "the subject device is substantially equivalent as the predicate devices" and "does not raise different questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the non-clinical tests mentioned. The "negative pressure test" and "human factors evaluation" would likely involve laboratory or simulated testing rather than patient data in the context of an established device's performance characteristics.
- Data Provenance: Not applicable in the context of patient data for an AI/ML algorithm. These are non-clinical (laboratory/engineering) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no ground truth established by experts as this is not a diagnostic AI/ML device study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no ground truth established by 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
No, an MRMC comparative effectiveness study was not done. This device is a negative pressure wound therapy unit, not an AI 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 not an AI algorithm. The device performance stands alone as a physical therapy unit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for the non-clinical tests would be engineering specifications and functional requirements (e.g., pressure output, functionality as per design).
8. The sample size for the training set
Not applicable. There is no AI/ML model with a training set described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model with a training set described in this document.
Summary of the Study per the Document:
The provided document describes a 510(k) submission for the Prevena Plus 125 Therapy Unit, aimed at demonstrating substantial equivalence to predicate devices. The "studies" conducted were non-clinical tests and a human factors evaluation. These tests confirmed that the device "maintains negative pressure within specifications" and "functioned as intended" when used with V.A.C. Dressings. The purpose was to show that adding the "open wound" indication, similar to a reference device, does not raise new questions of safety or effectiveness. The standard for substantial equivalence for this type of medical device does not typically require the extensive clinical validation and AI-specific study details requested in the prompt.
§ 878.4783 Negative pressure wound therapy device for reduction of wound complications.
(a)
Identification. A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under § 878.4780. This classification does not include devices intended for organ space wounds.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
(i) Wound complication rates; and
(ii) All adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(5) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use.
(6) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life:
(i) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life;
(ii) Fluid removal rate consistent with the wound types specified in the indications for use; and
(iii) Timely triggering of all alarms.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include the following:
(i) Instructions for use;
(ii) A summary of the device technical specifications, including pressure settings, modes (
e.g., continuous or intermittent), alarms, and safety features;(iii) Compatible components and devices;
(iv) A summary of the clinical evidence for the indications for use;
(v) A shelf life for sterile components; and
(vi) Use life and intended use environments.
(10) For devices intended for use outside of a healthcare facility, patient labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) Information on when to contact a healthcare professional; and
(iii) Use life.