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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) in men age 50 and above.

The UroLift® System is composed of two main components: the UroLift® Delivery Device and UroLift® Implant (Figure 1). Each Delivery Device comes pre-loaded with one UroLift® Implant. The insertion of the UroLift® Delivery Device into the male urethra is performed under direct visualization using standard surgical technique, using a standard cystoscopy sheath and a Karl Storz 10324AA telescope. The UroLift® Delivery Device is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift Delivery Device is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. A 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 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 UroLife® Implant (Figure 2).

The UroLift System is an implantable transprostatic tissue retractor system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Acceptance Criteria and Reported Device Performance

The clinical study for the UroLift System, known as the L.I.F.T. (Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms) Pivotal Study, established the following acceptance criteria and demonstrated performance:

• Qmax: 63.5% increase at 3 months over baseline and 54.8% at 12 months.
• IPPS at 2 weeks: Symptom relief began as early as 2 weeks.
• Quality of Life (QoL): Improved from 4.9 at baseline to 1.8 at 6 weeks and 2.4 at 12 months.
• BPHII: Decreased 73% at 6 weeks and remained close out to 1 year (64.6 % and 66.7% respectively).
• IIEF (International Index of Erectile Function): Showed preservation of function with no statistical change from baseline at 12 months. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: A total of 206 subjects were randomized in a 2:1 ratio (UroLift: 140; Control: 66).
• Data Provenance: The study was a prospective, multinational clinical trial.
  • Countries of Origin: U.S. (14 investigational sites) and non-U.S. (5 sites: three in Australia and two in Canada).
  • Nature of Data: Prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the "number of experts used to establish the ground truth" in the context of diagnostic interpretation or image review for the test set. Instead, the ground truth for effectiveness was based on patient-reported outcomes (IPSS, QoL, BPHII) and objective measures (Qmax), and safety outcomes (adverse events, catheterization rates).

• Clinical Trial Design: The effectiveness assessment was double-blinded in terms of both the subject and the assessor for the initial 3-month period. This implies that the assessors evaluating the outcomes were clinical professionals with the necessary qualifications to conduct these assessments.
• Safety Event Adjudication: An independent reviewer adjudicated one event in the Australian Feasibility Study to be both a procedure and a device-related event. For the Pivotal Study, it states "Of 20, only 6 were adjudicated to be procedure or device related." This indicates that expert clinical review (adjudication) was performed for adverse events. The specific qualifications of these adjudicators are not detailed, but it can be inferred they were qualified medical professionals (e.g., urologists or clinical investigators).

4. Adjudication Method for the Test Set

• Safety Event Adjudication: For the Feasibility Study, "An independent reviewer adjudicated one event to be both a procedure and a device related event." For the Pivotal Study, "Of 20, only 6 were adjudicated to be procedure or device related." This suggests that adverse events were subject to expert review and classification. The exact number of adjudicators per event (e.g., 2+1 or 3+1) is not specified, but it was not "none".
• Effectiveness Assessment: The effectiveness assessment was "double blinded in terms of both the subject and the assessor" for the primary endpoints at 3 months. This implies a rigorous, standardized assessment without mentioning a specific adjudication method for primary outcome measures beyond this double-blinding.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a clinical trial comparing the UroLift System to a sham control, focusing on patient outcomes and device efficacy/safety, not on human reader performance with or without AI assistance. The device itself is a medical implant and delivery system, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. The UroLift System is a medical device (implant and delivery system) for a surgical procedure, not an algorithm or AI system to be evaluated for standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical studies was established through:

• Patient-Reported Outcomes: International Prostate Symptom Score (IPSS), Quality of Life (QoL) index, and Benign Prostatic Hyperplasia Impact Index (BPHII), International Index of Erectile Function (IIEF). These are subjective measures reported by the patients themselves.
• Objective Clinical Measurements: Peak flow rate (Qmax), observations of adverse events (including catheterization duration), and various clinical assessments by investigators.
• Adjudicated Adverse Events: As mentioned above, some adverse events were adjudicated by independent reviewers.

8. The Sample Size for the Training Set

• Not applicable in the context of AI/ML. The UroLift System is a physical medical device. The "training" for its development involved non-clinical bench, animal, and cadaver studies, as well as an earlier "Feasibility Study" (64 subjects followed for 5 years in Australia) which refined methods and gathered initial safety/feasibility data before the larger Pivotal Study. This feasibility study could be considered analogous to early-stage development and refinement, but not a "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable as it's not an AI/ML device. For the "feasibility study" mentioned (which provided early clinical data used to refine the device and inform the pivotal study), the ground truth was established similarly to the pivotal study, through patient-reported outcomes (subject questionnaire responses) and safety events observed by investigators ("Site reported adverse events"). One event was independently adjudicated.

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