(90 days)
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 System 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 includes two generations of the device, the UL400 and the UL500. Both generations use the same UroLift Implant. The only differences are in the delivery device.
The UL400 (cleared in K133281), 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 UL500 (UroLift 2 System, cleared in K172359) 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 cartridge is pre-loaded with one UroLift Implant. The cartridges fit into the delivery handle. Each patient procedure will use one dedicated handle and the number of cartridges/implants necessary to perform a typical procedure (estimated 2-6 implants). For the UL500, users are also provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the Delivery Handle.
The provided text describes a 510(k) submission for the UroLift System (UL400 and UL500) and includes information about a clinical study conducted to support its safety and effectiveness, specifically for patients with an enlarged median lobe.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness Endpoint (at 6 months): The 95% lower confidence limit of the mean percent improvement in subject's International Prostatic Symptom Score (IPSS) over baseline for the UroLift System must be $\geq$ 25%. | Results: At 6 months, the 95% lower confidence limit of the mean percent improvement in subject's International Prostatic Symptom Score (IPSS) over baseline for the UroLift System was 50.8%, which is substantially above the goal of $\geq$ 25%. The mean percent change at 6 months was 57.7%. |
| Safety Endpoint (at 3 months): The composite observed rate of post-procedure device-related serious complications ≤ 15%. Composite device-related serious complications include: de Novo (new) severe urinary retention lasting more than 21 consecutive days post procedure, device-related formation of fistula between the rectum and urethra, perforation of the rectum or GI tract, damage to ureter or ureteral orifices, damage to the trigone requiring surgical repair, or de novo, sustained erectile dysfunction. | Results: The safety endpoint was achieved with 0% (5.7% CI upper limit) meeting criteria within the composite. From 3 to 6 months, there were no reported events that would meet the endpoint criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size: 45 subjects were enrolled in the study.
- Data Provenance: The study was a prospective, multicenter, non-blinded, single-arm study conducted at 9 investigational sites located in the US. It gathered data through 1, 3, 6, and 12 months of follow-up.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The information provided does not specify the number of experts or their qualifications used to establish ground truth for the test set in the conventional sense of image or diagnosis review. Instead, a Clinical Events Committee (CEC) was used for adjudication related to the safety endpoint.
4. Adjudication method for the test set
- Adjudication Method: A Clinical Events Committee (CEC) was responsible for adjudicating adverse events and relevant subject questionnaires to evaluate against the safety endpoint. The specific composition or method (e.g., 2+1, 3+1) of the CEC is not detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the performance of the UroLift System directly on patients, not on human reader performance with or without AI assistance. This device is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The UroLift System is a medical device (implantable system) that is used in a procedure performed by a clinician. Its "performance" is measured by its impact on patient symptoms and safety, not as a standalone algorithm.
7. The type of ground truth used
- Ground Truth: The ground truth for the effectiveness endpoint was based on patient-reported outcomes, specifically the International Prostatic Symptom Score (IPSS).
- The ground truth for the safety endpoint was based on clinical events adjudicated by a Clinical Events Committee against predefined criteria for serious complications.
8. The sample size for the training set
- Training Set Sample Size: The document does not mention a "training set" as this is a clinical trial for a medical device and not an AI/machine learning model that would typically have a training set. The 45 enrolled subjects constitute the study population for evaluating the device's safety and effectiveness.
9. How the ground truth for the training set was established
- This question is not applicable as there was no explicit "training set" in the context of an AI/ML model for this medical device study. The ground truth for evaluating the device's performance was established through the objective measurement of IPSS scores and the adjudication of adverse events by a CEC.
§ 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.