(80 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 PrevenaTM Incision Management System consists of the following components: A single use, sterile dressing that is applied in a simple peel and place process. Negative pressure is provided to the dressing via a negative pressure therapy unit. Wound fluids are collected in a sterile, disposable canister. The PrevenaTM Incision Management System is intended for continuous application of negative pressure wound therapy to the closed surgical incision immediately after surgery.
The provided document is a 510(k) summary for the Prevena™ Incision Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (ActiV.A.C.® Therapy System) and includes various tests to assure conformance to design specifications.
However, the document does not describe acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a device as one would typically expect for an AI/algorithm-driven device's clinical performance. Instead, the acceptance criteria are implicitly tied to the successful completion of various engineering, biocompatibility, and usability tests, as well as demonstrating equivalence in delivering negative pressure wound therapy.
Therefore, the requested tables and details related to performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not available and cannot be extracted from the provided text. The device is a physical system that delivers negative pressure wound therapy, not an algorithm that makes diagnostic or prognostic predictions requiring such clinical performance criteria.
Here's a breakdown of what can be extracted, reinterpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and product safety/efficacy based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't present acceptance criteria in terms of clinical performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the successful completion of various tests designed to demonstrate substantial equivalence and functional safety. The "reported device performance" refers to the outcomes of these tests.
| Acceptance Criteria (Implied by Test Objective) | Reported Device Performance |
|---|---|
| Functional Equivalence: Delivery of negative pressure wound therapy equivalent to predicate device. | Testing demonstrated that the Prevena Incision Management System and the ActiV.A.C. Therapy System are equivalent under all test conditions for delivery of negative pressure wound therapy. |
| Software Functionality: Meet all software requirements specifications. | Software verification and validation testing confirmed the ability of the software to meet all software requirements specifications. |
| Electrical Safety & EMC: Compliance with UL 60601-1 and EN 60601-1-2 standards. | Electromagnetic compatibility and electrical safety tests conducted per UL 60601-1 and EN 60601-1-2, documenting compliance with the standards. |
| Microbial Barrier: Polyurethane shell serves as a microbial barrier (no viral penetration). | A Phi-X 174 bacteriophage challenge of the polyurethane film indicated no viral penetration. |
| Fluid Wicking: Skin contact layer moves fluid away from skin (high wicking capability, no silver ion migration). | A wicking study verified that the fabric has a high wicking capability for the test fluid in the absence of negative pressure, and confirmed no silver ions migrated out of the fabric. |
| Antimicrobial Activity: Significant log reduction against tested microorganisms. | In vitro log reduction tests on polyurethane-coated polyester fabric with silver showed significant reductions from Day 0 values for various microorganisms: |
- Escherichia coli: Day 1=2.2, Day 3=4.0, Day 5=3.9, Day 7=4.5
- Pseudomonas aeruginosa: Day 1=2.0, Day 3=3.9, Day 5=3.5, Day 7=3.7
- Staphylococcus aureus: Day 1=1.6, Day 3=3.6, Day 5=3.6, Day 7=3.5
- Klebsiella pneumonia: Day 1=1.4, Day 3=1.8, Day 5=2.7, Day 7=3.5
- Candida albicans: Day 1=2.5, Day 3=3.1, Day 5=3.2, Day 7=3.2
- Aspergillus niger: Day 1=2.2, Day 3=4.1, Day 5=4.0, Day 7=3.6 |
| Biocompatibility: Meet ISO 10993-1 standards (cytotoxicity, irritation, sensitization). | Cytotoxicity, irritation, and sensitization testing performed in accordance with ISO 10993-1 standards demonstrated the device is biocompatible. |
| Usability: System can be used by lay users and healthcare professionals (understand labeling, respond to alarms). | A validation of the usability was assessed by a simulated patient group (without healthcare experience) and a group of operating room nurses. Both studies confirmed the ability of participants to use the therapy system, understand labeling, and respond to alarms. |
Regarding the other requested information (2-9):
The provided document describes a medical device, specifically a negative pressure wound therapy system, not an AI/algorithm-driven diagnostic or assistive tool. Therefore, the concepts of "test set," "training set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," and "standalone algorithm performance" as typically applied to AI systems are not applicable to this device and are not mentioned in the document.
The "studies" described are design verification and validation tests for the physical device, its components, and its functional properties, rather than studies assessing the performance of an algorithm against a ground truth dataset.
Specifically:
- Sample size used for the test set and the data provenance: Not applicable. The "tests" are engineering and biological evaluations, not clinical performance studies on a "test set" of patients or data in the context of AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as this is not an interpretive AI device. Experts were involved in the usability studies (operating room nurses, simulated patient group), but not for establishing a "ground truth" for a dataset.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 therapy system, not an AI assistance tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is being assessed for standalone performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI device. The "ground truth" for the tests performed relates to physical properties (e.g., presence/absence of viral penetration, wicking capability, microbial count reduction, electrical safety standards compliance).
- The sample size for the training set: Not applicable. No training set for an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 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.