(23 days)
The BioArc™ SP Sling Kit is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The BioArc SP Sling Kit is a sterile, single use procedure kit consisting of two stainless steel. 22cm curved needle passers (also called insertion tools) and two AMS Polypropylene sling Y-mesh. At one end of the sling Y-mesh, a clamp is attached by polypropylene suture to each leg of the "Y". The clamp is used for suturing a tissue graft to the sling Y-mesh. A dilating connector is attached to the opposite end of the sling Y-mesh. The dilating connector secures to the keyed end of the BioArc SP needle passer during the procedure to facilitate sling placement. A fixed polypropylene tensioning suture runs through the middle of each sling Y-mesh. A plastic sheath covers each sling Y-mesh and protects it during placement. The same suprapubic approach used to place the SPARC sling mesh is used to place the BioArc SP sling Y-mesh.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (BioArc SP™ Sling Kit) and focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot populate the requested table and answer the specific questions about a performance study, acceptance criteria, sample size, expert qualifications, or ground truth establishment.
The document states:
- "A risk analysis for the BioArc SP and the verification and validation activity reported in this Special 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness."
This indicates that verification and validation studies were performed to support substantial equivalence, but the details of these studies, including specific performance metrics, acceptance criteria, and study methodologies, are not provided within this summary. This type of information is typically found in a more detailed study report, which is not part of this 510(k) summary.
§ 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.