(23 days)
For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.
[Trade name] is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.
This document is a 510(k) summary for a surgical mesh. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The information provided describes the device, its intended use, and states that its technological characteristics and performance are "the same as or equivalent to the predicate device." It also mentions that "Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device." However, no specific details about these tests, the acceptance criteria used, or the results are provided.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance study results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a high-level summary for regulatory submission, not a detailed study report.
§ 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.