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The UroLift 2 System (UL500) is intended for treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.

The UroLift 2 System (UL500) is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift Implant Cartridges (single-use) and the UroLift Implants (one implant per cartridge). Each patient procedure will use one dedicated sterile handle and the number of cartridges/implants necessary to perform a successful procedure (estimated 2-6 implants). The cartridges fit into the delivery handle.

The UroLift 2 System (UL500) is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift 2 System (UL500) 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. The implants secure the retracted position of the urethra thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving 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.

Minor modifications have been made to the UroLift 2 System (UL500) to improve the device. The overall design, as well as the patient contacting materials, is substantially equivalent to the predicate device.

Users are now provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the device handle. In addition, a Suture Support Tube has been incorporated into the device to provide additional support to the suture during Implant Cartridge assembly at NeoTract's manufacturing facility.

The provided document describes a 510(k) premarket notification for the UroLift 2 System (UL500), which is a medical device and not an AI/ML powered device. Therefore, the information requested in your prompt about an AI device's acceptance criteria, study details, and related metrics (such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance) cannot be found in this document.

The document primarily focuses on establishing substantial equivalence to a predicate device based on:

• Intended Use: Treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
• Technological Characteristics: Minor modifications (optional Scope Seal, Suture Support Tube) to improve the device, but the overall design and patient-contacting materials are substantially equivalent to the predicate. The UroLift Implant is identical.
• Performance Testing: Testing demonstrated the modified device meets the same performance requirements as the predicate, plus additional requirements for the Scope Seal. The changes do not affect the implant deployment procedure.

Without additional information about an AI/ML component or a separate study describing such, I cannot fulfill your request as it pertains to an AI device.

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