Search Results

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.

The UroLift 2 ATC Advanced Tissue Control System is a modification of the UroLift 2 System (last cleared in K201837). The primary difference is the addition of a wing component on the distal tip of the UroLift 2 ATC Advanced Tissue Control System which provides a larger footprint. This design feature is intended to provide better mobilization of tissue when performing the UroLift System procedure.

The UroLift System (both the UroLift 2 and UroLift 2 ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift 2 System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift 2 System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UroLift 2 ATC Advanced Tissue Control System consists of two main components, the UL2 Delivery Handle and the UroLift 2 ATC Implant Cartridge (single use). Each UroLift 2 ATC Implant Cartridge comes pre-loaded with one UroLift Implant. The Delivery Handle with the Implant Cartridge installed is known as the Delivery Device.

This document is a 510(k) summary for a medical device called the UroLift 2 ATC Advanced Tissue Control System. It describes the device's design, intended use, and how it compares to a predicate device and a reference device. It also outlines the performance and biocompatibility testing conducted to demonstrate substantial equivalence.

However, the provided text does not contain information about acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML medical device submission. This document is for a mechanical medical device, specifically an "Implantable Transprostatic Tissue Retractor System," which treats benign prostatic hyperplasia (BPH). The information requested in your prompt (acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are all highly relevant to the evaluation of AI/ML-driven medical devices.

Since the provided text does not describe an AI/ML device or its performance study, I cannot extract the requested information. The document focuses on demonstrating substantial equivalence to a predicate mechanical device through mechanical performance testing, biocompatibility testing, sterilization, and shelf-life testing, not on AI/ML model performance.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device approval from this document.

Ask a specific question about this device