(116 days)
The Prevena™ Restor™ Adapti-Form™ Dressing is part of the Prevena™ Restor™ Incision Management System and 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 Restor™ Incision Management System consist of the following components for use together as a system:
- Prevena Plus Therapy Unit & canister
- Prevena Restor Adapti-Form Dressing:
- Foam Dressing with a skin interface layer
- V.A.C. Drape
- SensaT.R.A.C. Pad
- Hydrocolloid Sealing strips
The Prevena™ Restor™ Adapti-Form™ Dressing is designed to be compatible for use with previously cleared V.A.C. Negative Pressure Wound Therapy (NPWT) Units:
- ActiV.A.C. Therapy Unit,
- V.A.C. ULTA Therapy Unit, and
- V.A.C. Rx4 Therapy Unit.
The provided document describes the Prevena™ Restor™ Adapti-Form™ Dressing, a part of the Prevena™ Restor™ Incision Management System. It explicitly states that clinical and pre-clinical testing were NOT necessary to demonstrate substantial equivalence. Therefore, there are no acceptance criteria, performance data, or studies presented in this document that would typically involve sample sizes, expert qualifications, or ground truth establishment in the context of device performance in a clinical setting.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Prevena™ Restor™ Incision Management System, K181507) and a reference device (Prevena Plus Incision Management System, K153199) through a comparison of technological characteristics and non-clinical tests.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical performance criteria are not applicable based on the document's statement, the "acceptance criteria" here refer to the successful completion of non-clinical tests.
| Acceptance Criterion (Non-Clinical Test Passed) | Reported Device Performance (Result) |
|---|---|
| Prevena Restor Incision Management System negative pressure test | Functioned as intended; test results passed. |
| Package Integrity/Stability testing (ISO 11607-1) | Functioned as intended; test results passed. |
| Product performance stability testing of dressing components after sterilization | Functioned as intended; test results passed. |
| Human factors evaluation | Functioned as intended; test results passed. |
| Biocompatibility testing (ISO 10993-1) | Functioned as intended; test results passed. |
2. Sample size used for the test set and the data provenance
Not applicable. The document explicitly states that "Clinical and Pre-clinical testing were not necessary to demonstrate substantial equivalence." The non-clinical tests listed (e.g., negative pressure test, package integrity) do not involve human patient test sets in the typical sense; they assess product specifications and safety characteristics. Information about the sample size of materials or units used for these engineering/safety tests is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As clinical or pre-clinical performance studies were not conducted for substantial equivalence, there was no need for experts to establish ground truth on patient outcomes or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or pre-clinical performance studies involving adjudication were performed.
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. The device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As clinical performance studies were not conducted, there was no ground truth related to patient conditions or diagnoses. The "ground truth" for the non-clinical tests would have been the pre-defined engineering and safety specifications or industry standards.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set was involved.
§ 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.