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

The Laparotomy 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 is the Laurus Medical Disposable Suture Placement System.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit.

Unfortunately, the provided document does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the requested table and the subsequent points about sample sizing, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training set information cannot be extracted from this document as they are not present.

The document primarily covers:

• Sponsor/Applicant information
• Device name
• Identification of predicate devices
• Device description
• Intended use
• Comparison of technological characteristics to predicate devices
• FDA's letter of clearance based on substantial equivalence.

Key takeaway: This 510(k) focuses on regulatory clearance via substantial equivalence, not on a detailed performance study with defined acceptance criteria.

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