(32 days)
Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Polyform™ Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient's needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.
The provided text is a 510(k) summary for the Polyform™ Synthetic Mesh. It describes the device, its intended use, and a summary of testing. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or AI algorithm performance.
The "SUMMARY of TESTING" section states that:
- "Bench test data reveal Polyform™ Synthetic Mesh has mechanical and material characterization values that are substantially equivalent to the predicate devices."
- "The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and nonsensitizing to biological tissues consistent with their intended use."
- "Updated test data on the bench and the rodent, as summarized in the updated product brochure, shows comparable technical properties to the more contemporary material properties like those in the Gynemesh PS."
This indicates that the device's substantial equivalence was established through bench testing, biocompatibility testing, and rodent studies comparing its material properties and mechanical characteristics to predicate devices. These are not studies that would involve clinical acceptance criteria, human readers, ground truth established by experts, or AI algorithm performance as typically understood for diagnostic or prognostic AI devices.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study details or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These specific requirements pertain to studies evaluating the performance of AI/CADe devices, which this document does not describe. The summary focuses on the physical and biological properties of a surgical mesh, not a software or AI-driven diagnostic tool.
§ 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.