(105 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 text describes a 510(k) submission for the "Prevena Incision Management System with Customizable Dressing." The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria in the typical sense of a new clinical claim. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance is not present in this regulatory document.
However, based on the provided text, I can extract and infer some information regarding the "acceptance criteria" (understood here as the demonstration of substantial equivalence) and the studies conducted to support it.
1. Table of "Acceptance Criteria" and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are generally framed around demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The key "performance" here is equivalence to the predicate.
| Acceptance Criteria (Demonstrated Equivalence Aspect) | Reported Device Performance (as stated in submission) |
|---|---|
| Biocompatibility (per ISO 10993-1) | Testing conducted to assure safety, efficacy, and conformance to design specifications. |
| Delivery of Negative Pressure Wound Therapy (Equivalency of Customizable Dressing to Peel and Place Dressing) | The Prevena Incision Management System with Customizable Dressing was evaluated under design verification and validation tests. Testing demonstrates substantial equivalence in terms of both indications for use and delivered wound therapy. |
| Software Verification and Validation | Testing conducted. |
| Functional Components Equivalence | The subject device was found to be equivalent to the predicate device in delivery of negative pressure to the indicated wound type. The devices are equivalent in terms of functional components. |
| Indications for Use Equivalence | Same as predicate (Closed surgical incisions). Testing demonstrates substantial equivalence in terms of both indications for use and delivered wound therapy. |
| Therapy Unit Equivalence | Therapy unit is "Same as predicate" (Single patient use only; battery powered). |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for any test sets used in the biocompatibility, equivalency, or software verification and validation tests. The term "test set" as typically used in AI/Machine Learning evaluation (i.e., a dataset of cases used to evaluate an algorithm's performance) is not applicable here as this is a medical device regulatory submission focused on mechanical and functional equivalence, not an AI product.
Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as the studies are likely laboratory-based and engineering verification/validation tests, not clinical studies with patient data in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of studies described. The "ground truth" for these tests would be established by engineering specifications, validated measurement techniques, and regulatory standards (e.g., ISO 10993-1) rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI datasets where expert opinions might differ. The studies mentioned (biocompatibility, equivalency testing, software V&V) are engineering and laboratory-based.
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 MRMC comparative effectiveness study was done or mentioned. This device is not an AI-assisted diagnostic or prognostic tool for human readers; it is a negative pressure wound therapy system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device (negative pressure wound therapy system), not an algorithm or AI.
7. The type of ground truth used
The "ground truth" in this context refers to the established standards or predicate device performance against which the new device is compared.
- Engineering Specifications: For functional performance (e.g., negative pressure delivery).
- Regulatory Standards: For biocompatibility (ISO 10993-1).
- Predicate Device Performance: For demonstrating equivalence in indicated wound types, functional components, and therapy unit operation.
8. The sample size for the training set
Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.