(14 days)
TephaFLEX® Surgical Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
TephaFLEX® Surgical Mesh is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
The provided document, K070894, describes information about the TephaFLEX® Surgical Mesh. However, it does not contain the type of study information (e.g., about AI/algorithm performance, ground truth, expert review) you're asking for. This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through physical testing and comparison of material properties, rather than clinical efficacy or AI-driven performance metrics.
Therefore, I cannot extract the requested information from this document. The sections you've asked for (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and training set ground truth establishment) are typical for AI/ML device submissions, which are not applicable to the TephaFLEX® Surgical Mesh described in K070894.
The document states:
- Safety and Performance: "Physical testing was performed on the TephaFLEX® surgical mesh which determined the TephaFLEX mesh to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions."
- Conclusion: "Based on the indications for use, technological characteristics, and safety and performance testing, the TephaFLEX® Surgical Mesh has been shown to be substantially equivalent to predicate devices..."
This indicates that the "study" was primarily physical testing demonstrating mechanical equivalence, not a clinical study involving human or AI performance data.
§ 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.