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The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is indicated for urethropexy procedures for bladder neck suspension to correct female stress incontinence due to urethral hypermobility.

The Laparoscopic Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray. The suture placement system that is offered in the kit is the Laurus Medical Disposable Suture Placement System.

I am sorry, but the provided text primarily consists of a 510(k) summary for the "Louisville Laboratories, Inc. Laparoscopic Suspension Kit." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study that proves the device meets acceptance criteria through performance data.

Therefore, the document does not contain the information necessary to fill out a table of acceptance criteria and reported device performance or answer the specific questions about study design, sample sizes, expert ground truth, adjudication, or MRMC comparative effectiveness. The text highlights:

• Intended use: Bladder neck suspension for female stress incontinence due to urethral hypermobility.
• Device description: Comprised of a template assembly, suture retriever, suture cutter, and suture placement system.
• Technological characteristics comparison: States similarity in components and method of positioning sutures to predicate devices.
• Predicate devices: Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076) and Laurus Medical Suturing System (K932553).

The 510(k) process typically relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often by showing similar technological characteristics and intended use, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics for the new device as would be seen in a PMA or De Novo submission.

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