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UroLift System 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 System UL500 is comprised of the UroLift® Delivery Handle (single patient resusable), 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 System UL500 is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift 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.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for the UroLift® System UL500, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study for initial device efficacy.

While it mentions "Performance Testing" was conducted, it only states that "the device meets the same performance requirements of the predicate device" and that "the changes made to the device do not affect the implant deployment procedure." It does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about the test set.
• Information about experts, ground truth establishment, or adjudication methods.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample size or ground truth details for a training set.

The document primarily focuses on establishing that modifications to the UroLift System UL500 do not introduce new questions of safety or effectiveness compared to its predicate device, rather than providing a detailed study of its primary efficacy or safety from scratch.

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