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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 Advanced Tissue Control (ATC) System is a modification of the UroLift UL400 System (last cleared in K193269). The primary difference is the addition of a wing component on the distal tip of the UL400 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 UL400 and UroLift ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift 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 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 System consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.

The provided text is a 510(k) summary for the UroLift Advanced Tissue Control (ATC) System. It describes the device, its intended use, comparison to a predicate device, and performance testing. However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it discuss ground truth establishment, expert review, or multi-reader multi-case studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing (deployment, compatibility, implant/shaft/wing performance), biocompatibility, sterilization, and shelf-life testing. These are typical engineering and safety tests for a physical medical device, not a software algorithm with diagnostic or prognostic capabilities.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the context of AI/ML or diagnostic performance, nor can I answer the questions about sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

The document explicitly states:

• "The design requirements for the UroLift System were reviewed and non-clinical design verification testing was required to assure that the modifications of the proposed device did not impact the safe and effective use of the device."
• "Non-clinical testing included deployment testing, compatibility with accessories, and implant, shaft, and wing performance testing."
• "The majority of the test methods were equivalent to the testing for the 510(k) cleared UroLift UL400 System (K193269), and all acceptance criteria were met."

This indicates that the "acceptance criteria" referred to are related to the physical performance and safety of the device, not its diagnostic accuracy or human-in-the-loop performance in an AI/ML context.

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