(15 days)
Reconstruction of Hernias and Soft Tissue Deficiencies and for the Temporary Bridging of Fascial Defects
The GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS Biomaterials are patch materials composed solely of expanded polytetrafluoroethylene (ePTFE) loaded with two antimicrobial preservative agents, chlorhexidine diacetate and silver carbonate (referred to as PLUS). The device incorporates a microporous node and fibril structure with regularly spaced macropores. This structure ensures early fixation to host tissue with minimal foreign body response and extensive vascularization. The PLUS acts as a preservative and prevents bacterial colonization of the device during the short-term postoperative period. The GORE DUALMESH PLUS Biomaterial is intended for reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The device is available in 1 mm, 1.5 mm, and 2 mm thicknesses.
The provided text is a 510(k) summary for the GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS Biomaterials. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets them in the way clinical diagnostic device studies are typically described.
Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, as it pertains to a performance study with quantitative metrics, is not available in this submission.
Here's a breakdown of the information that can be extracted, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided 510(k) summary in terms of numerical thresholds for clinical performance (e.g., sensitivity, specificity, accuracy). The submission focuses on demonstrating "substantial equivalence" based on composition, design, intended use, mode of operation, and performance attributes compared to a predicate device (GORE DUALMESH® PLUS BIOMATERIAL (K946106)).
The "reported device performance" is implicitly that it performs equivalently to the predicate device for its intended use, which is "reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects." The "PLUS" component adds antimicrobial preservative agents.
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable/not provided. This submission does not describe a clinical performance test set with human subjects or retrospective data in the manner a diagnostic device would. Evaluation of surgical mesh typically involves preclinical (e.g., animal, in vitro) testing for biocompatibility, mechanical properties, and, in this case, antimicrobial efficacy, which are not detailed in this summary.
- Data provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable/not provided as there is no mention of a test set requiring expert ground truth establishment in this type of submission for a surgical mesh.
4. Adjudication method for the test set
- This is not applicable/not provided as there is no mention of a test set requiring adjudication.
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
- This is not applicable/not provided. This is a surgical mesh, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable/not provided. This is a surgical mesh, not an algorithm.
7. The type of ground truth used
- This is not applicable/not provided as there is no mention of a test set requiring ground truth. The evaluation of this device would involve demonstrating material properties, biocompatibility, and antimicrobial efficacy (for the "PLUS" agents) rather than a diagnostic ground truth.
8. The sample size for the training set
- This is not applicable/not provided, as this is a physical medical device (surgical mesh), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable/not provided for the reasons stated above.
In summary:
The provided 510(k) summary for the GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS Biomaterials is for a surgical mesh, not a diagnostic device or AI-enabled product. Therefore, the information requested, which is largely pertinent to the performance evaluation of diagnostic algorithms and expert-based ground truth, is not present in this type of regulatory submission. The "study" mentioned generally refers to the preclinical testing and comparison to the predicate device that demonstrated substantial equivalence, which are not detailed in this public summary.
§ 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.