(159 days)
Desara® TV and Desara® Blue TV are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
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The provided text is a 510(k) premarket notification letter from the FDA regarding surgical mesh products (Desara TV and Desara Blue TV). It discusses regulatory aspects, general controls, and indications for use.
However, the document DOES NOT contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory approval letter and does not delve into the technical validation of the device's performance.
§ 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.