(44 days)
Reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
The proposed Composix E/X Mesh will be elliptical in shape and manufactured from a single layer of knitted polypropylene monofilament. A single layer of expanded polytetrafluoroethylene (ePTFE) will be attached to this mesh with polytetrafluoroethylene (PTFE) monofilament thread. The peripheral edge of the polypropylene mesh will be heat sealed to the ePTFE layer.
The provided text is a 510(k) summary for the Composix E/X Mesh, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.
Therefore, many of the requested categories (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, specific ground truth types with numbers) are not applicable to this type of regulatory submission and information provided.
However, I can extract the information that is present:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and non-sensitizing to biological tissues consistent with intended use. | Biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with their intended use. |
| Bench Testing: Materials and design meet established specifications for consistent performance during intended use. | Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing the Composix E/X Mesh will meet the established specifications necessary for consistent performance during their intended use. |
Study Details (Information Not Applicable or Not Provided in this Document)
- Sample size used for the test set and the data provenance: Not applicable. This document refers to biocompatibility and bench testing, not a clinical study with a "test set" in the context of AI/diagnostic device evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established by experts for this type of device submission.
- 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 is a mesh implant, not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly described in terms of a "ground truth" for a diagnostic study. The "ground truth" for biocompatibility would be the established safety profiles for the materials, and for bench testing, it would be the pre-defined engineering specifications for mechanical properties.
- The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.