(190 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness Endpoints | |
| Mean IPSS improvement from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to cystoscopy alone (Control Group). | UroLift System group demonstrated superiority to control at 3 months. IPSS was reduced from baseline by 50.0% at 3 months. |
| Lower bound of a one-sided 97.5% confidence interval of mean percent change (improvement) from baseline in IPSS at 12 months in the UroLift® group is ≥ 30%. | Improvement of the treated group at 12 months was statistically significant compared to their baseline IPSS. IPSS was reduced from baseline by 45.5% at 12 months. |
| Safety Endpoints | |
| Upper bound of a one-sided 97.5% confidence interval of the observed rate of post-operative urinary catheterization > 7 days is 7 days. The risks of the device include a low risk of serious adverse events. Most events were mild or moderate, transient, and resolved without sequelae or intervention. The adverse events had an onset within 7 days of procedure and resolved within 30 days following the procedure. | |
| Secondary Effectiveness Endpoints (Implicitly accepted if results show improvement) | Most secondary endpoints showed clinical and statistical improvement. These included: |
- 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.
§ 876.5530 Implantable transprostatic tissue retractor system.
(a)
Identification. An implantable transprostatic tissue retractor system is a prescription use device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(3) Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity, and device functionality over the requested shelf life.
(4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Mechanical strength must be conducted.
(iii) Resistance-to-degradation testing must be conducted.
(5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance environment.
(6) In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Implant migration must be conducted.
(7) Labeling must bear all information required for safe and effective use of the device, and must include:
(i) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) Information on the patient population for which the device has been demonstrated to be effective.
(iii) A detailed summary of the device technical parameters.
(iv) Information on how the device operates and the typical course of treatment.
(v) An expiration date/shelf life.
(vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.