(29 days)
The Prevena 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.
Negative pressure wound therapy system for application to surgically closed incisions.
The provided document is a 510(k) Summary for the Prevena Incision Management System with Customizable Dressing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for a new or significantly modified device. Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance, sample sizes for test and training sets, expert ground truthing, and MRMC studies is not present in this document.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 | Met (stated in "Summary of non-clinical tests") |
| Equivalency in delivery of negative pressure wound therapy | Met (stated in "Summary of non-clinical tests") |
| Safety | Substantially equivalent to predicate (K121883) |
| Efficacy | Substantially equivalent to predicate (K121883) |
| Conformance to design specifications | Met (stated in "Summary of non-clinical tests") |
| Functional components | Equivalent to predicate |
| Indicated wound types | Same as predicate (Closed surgical incisions) |
| Dressing | Same as predicate (Multiple dressing components) |
| Therapy unit | Same as predicate (Single patient use only; battery powered) |
Study Proving Acceptance Criteria:
The document states: "The Prevena Incision Management System with Customizable Dressing was evaluated under a number of design verification and validation tests to assure safety, efficacy, conformance to design specifications and equivalence to the predicate device."
Specifically, the following tests were conducted:
- Biocompatibility testing according to ISO 10993-1.
- Equivalency testing with respect to delivery of negative pressure wound therapy.
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 for test set: Not specified. The document only mentions "design verification and validation tests" and "non-clinical tests."
- Data provenance: Not specified. As these were non-clinical tests, the concept of "country of origin" for patient data isn't directly applicable.
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. The tests mentioned are non-clinical (biocompatibility and functional equivalency) and do not involve human interpretation or ground truthing by medical experts in the way an AI diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The tests mentioned are non-clinical and do not require expert adjudication.
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. The document explicitly states: "No clinical tests were necessary." This device is not an AI diagnostic tool that would typically involve MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (negative pressure wound therapy system), not an algorithm or AI. The "performance" refers to its mechanical and biological functionality, not an analytical algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Ground truth would be established by validated laboratory assays and compliance with ISO 10993-1 standards.
- For equivalency in negative pressure delivery: Ground truth would be established by engineering specifications and direct measurement/comparison to the predicate device's performance.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device that requires a training set.
§ 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.