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The PelviLace™ Transobturator BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue membranes. It is specifically indicated for use in the surgical repair of tissue resulting from damaged or ruptured soft tissue and for the inhibition of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Bard® PelviLace™ TO BioUrethral Support System consists of the PelviLace Pelvicol implant and introducers. The introducers are used to place the implant which provides a natural backboard for the urethra during abdominal pressure increases.

This document is a 510(k) summary for the PelviLace™ TO BioUrethral Support System, a suburethral sling device. It details the device's description, intended use, and technological characteristics compared to predicate devices. However, this document does not contain information related to specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory purposes.

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