(87 days)
The Ajust™ Adjustable Single Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The Ajust™ Adjustable Single Incision Sling is for use in urological and gynecological procedures for the treatment of stress urinary incontinence in women. The sling is secured in the patient's tissue using two soft tissue anchors. An introducer is used to insert the anchors using a similar approach to a transobturator sling. The implant design allows independent adjustment of the mesh relative to the anchors, after which, the mesh is secured in place using a small locking mechanism.
The provided text is a 510(k) summary for the Ajust™ Adjustable Single Incision Sling. It details the device's description, intended use, and states that bench, pre-clinical, and clinical data were used to determine equivalence to predicate devices. However, the document does not provide explicit acceptance criteria or a detailed study report with performance metrics.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I elaborate on specific aspects of a study that would demonstrate the device meets those criteria.
The information regarding sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established is not present in the provided text.
The document primarily focuses on establishing substantial equivalence based on the predicate devices and general performance testing, without disclosing the detailed results or methodologies that would be required to answer your specific questions.
§ 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.