(74 days)
An implantable surgical mesh prosthesis indicated for the reconstruction of hernias and soft tissue deficiencies.
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with antimicrobial preservative agents in a flat sheet configuration of various length and width dimensions. Macropores are placed in the device in order to optimize rapid tissue fixation.
This is a 510(k) summary for a medical device (GORE-TEX® DualMesh PLUS Biomaterial with Holes), not an AI/ML powered device, therefore the requested information regarding AI/ML study design and performance metrics is not applicable. The provided text describes the device's characteristics and its substantial equivalence to predicate devices based on mechanical strength testing.
Here's the relevant information that is available in the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | Reported Device Performance |
|---|---|
| Suture Pull-Out Force (kg/5 pins) | |
| Low Rate (Mean) | 7.7 |
| Low Rate (Std Dev) | 0.5 |
| High Rate (Mean) | 8.2 |
| High Rate (Std Dev) | 0.7 |
| Tensile Force to Break (kg/0.5") | |
| Mean | 8.3 |
| Std Dev | 0.3 |
Note: The document states that "Mechanical strength values of the applicant device are substantially equivalent to the mechanical strength values of the predicate devices and are sufficient for its indicated uses." The actual acceptance criteria (e.g., minimum thresholds for these mechanical properties) are not explicitly stated as numerical values in this summary but are implied by the comparison to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the bench testing (e.g., number of units tested for suture pull-out or tensile force). The data provenance is "bench testing," meaning in-vitro laboratory testing, not clinical data from countries or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is a medical device composed of materials, not an AI/ML diagnostic or prognostic tool requiring expert interpretation of data for ground truth. The "ground truth" for mechanical properties is established by standardized physical testing methodologies.
4. Adjudication Method
Not applicable. This is not a study involving expert review or interpretation of data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML powered device.
6. Standalone Performance Study
Not applicable. This is not an AI/ML powered device. The "standalone performance" is assessed through the mechanical bench testing reported.
7. Type of Ground Truth Used
The ground truth for the device's performance is established by physical measurement results from bench testing according to established engineering and material science protocols. Specifically, the "Tensile Force to Break" and "Suture Pull-Out Force" are objectively measurable properties.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML powered device which requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML powered device.
§ 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.