Search Results

GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.

GORE INFINIT Mesh is a flat nonabsorbable surgical mesh constructed from monofilament expanded polytetrafluorethylene (PTFE) fibers. The fibers are warp knitted into a textile pattern with bi-axial stretch that allows the material to comply with native tissue. The warp knit pattern also allows the mesh to be custom tailored without unraveling of the edges. The mesh is knitted with a pore size that allows appropriate tissue integration without negatively affecting abdominal wall compliance.

Here's an analysis of the provided text regarding the GORE INFINIT Mesh, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not mention a test set sample size or data provenance because the submission relies solely on bench testing and comparison to predicate devices, not clinical or animal studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No ground truth in the traditional sense was established with experts as there were no clinical trials or human/animal studies. The "ground truth" for demonstrating substantial equivalence was effectively the established performance of the predicate devices and the relevant FDA guidance.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method was mentioned as there were no clinical or animal studies requiring expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This device is a surgical mesh, not an AI or imaging diagnostic device. Therefore, a MRMC study or AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this submission was primarily:

• Predicate device characteristics and established safety/efficacy data: The GORE DUALMESH® Biomaterial and PROLENETM Soft Mesh provided the benchmark for comparison.
• "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh": This FDA guidance provided the framework and specific characteristics against which the bench testing was measured.

8. The Sample Size for the Training Set

Not applicable. There was no training set mentioned, as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary of the Study Proving Acceptance Criteria:

The study proving the device met its acceptance criteria was a non-clinical bench testing study.

• Methodology: The GORE INFINIT Mesh underwent bench testing to evaluate its performance characteristics. These characteristics were then compared to those of the predicate device, PROLENETM Soft Mesh, and assessed against the specifications outlined in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
• Results: The bench testing demonstrated that the GORE INFINIT Mesh had performance characteristics comparable to the PROLENETM Soft Mesh and complied with the relevant guidance.
• Conclusion: Based on this bench testing, the manufacturer concluded that the GORE INFINIT Mesh was substantially equivalent to its predicate devices in terms of design, intended use, principle of operation, and performance attributes. No significant safety or effectiveness issues were identified due to the differences between the new device and its predicates.

It is explicitly stated that "Nonclinical laboratory (animal) testing and clinical performance data were not evaluated as part of this application," indicating that the entire demonstration of equivalence was based on in-vitro (bench) testing and comparison to existing, approved devices.

Ask a specific question about this device