(28 days)
For use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
These devices are composed of expanded polytetrafluoroethylene (ePTFE) and antimicrobial agents. GORE-TEX ePTFE Medical Products have been available for more than two decades and the safety and efficacy of these devices have been confirmed by well over 5,000,000 implants. The applicant devices are intended for long-term implantation as reinforcing surgical meshes. They incorporate the antimicrobial agents silver carbonate and chlorhexidine diacetate to inhibit bacterial colonization of the device for up to ten days postimplantation.
This document is a Premarket Notification Summary for a medical device, specifically a surgical mesh. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting new performance data against specific acceptance criteria. Therefore, much of the requested information about device performance against acceptance criteria and details of a clinical study is not available in this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document's purpose is to seek clearance based on substantial equivalence to existing devices, not to demonstrate performance against new acceptance criteria. It states: "No new technological characteristics result from the addition of the presented contraindication. The applicant devices' design, performance and material characteristics are not being changed in any way and only the labeling is revised as a result of this submission's clearance." This means the device relies on the established safety and efficacy of its predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/provided in the context of the presented document. This document is not reporting on a study that used a 'test set' in the traditional sense of evaluating device performance against acceptance criteria. It refers to the historical use of similar devices: "GORE-TEX ePTFE Medical Products have been available for more than two decades and the safety and efficacy of these devices have been confirmed by well over 5,000,000 implants." This refers to real-world usage data, not a specific controlled test set for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable/provided. Since there's no new test set designed to establish ground truth for this submission, there were no experts used in this capacity as described.
4. Adjudication Method for the Test Set
This information is not applicable/provided. No such test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable/provided. The document does not describe an MRMC study. The device is a surgical mesh, not an imaging or diagnostic device that typically undergoes MRMC studies.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/provided. This device is a physical surgical mesh, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the safety and efficacy of the predicate devices (and by extension these substantially equivalent devices) is based on real-world clinical use and experience over "more than two decades" and "well over 5,000,000 implants." This can be considered a form of outcomes data and clinical experience. For the current submission, the "ground truth" for clearance is substantial equivalence to those predicates.
8. The Sample Size for the Training Set
This information is not applicable/provided. There is no "training set" as described for an AI/algorithm-based device. The basis for safety and efficacy relies on the extensive clinical history of the predicate devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. There is no explicitly defined "training set" for this submission. The "ground truth" for the overall device's safety and efficacy is established through decades of clinical use and millions of implants of the predicate devices, confirming their performance.
Summary:
This 510(k) premarket notification relies on demonstrating substantial equivalence to predicate devices with a long history of safe and effective use. It does not present new performance data against specific acceptance criteria or details of a new clinical study with test sets, experts, or adjudication methods in the context of typical medical device performance evaluation (especially for imaging or AI devices). The "proof" is the established safety and efficacy of the predicate devices over millions of implants.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.