(56 days)
The UroLift System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
The NeoTract UroLift System comprises two main components, the UroLift Delivery Device and UroLift Implant. 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 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 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 provided text describes a Special 510(k) submission for minor modifications to the NeoTract UroLift System and does not include a study demonstrating the device meets specific acceptance criteria in terms of clinical performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device (K130651) based on performance testing related to usability and reliability after minor modifications to the delivery device.
Therefore, most of the details requested in your prompt (e.g., specific acceptance criteria for clinical performance, sample size for test sets, number of experts for ground truth, MRMC study results, standalone performance, training set size) cannot be extracted from this document as these types of clinical performance evaluations are typically not conducted for Special 510(k) submissions focusing on minor modifications that do not raise new questions of safety or effectiveness.
However, based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria for clinical performance (e.g., AUA symptom score improvement, Qmax improvement) or reported device performance against such criteria. The "Performance Testing" section states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets same performance requirements as predicate device | Transit and functionality testing demonstrate this requirement is met. |
| Modified device does not affect usability | Usability test results confirm this requirement is met. |
| Modified device can be utilized in the same manner as predicate device | Usability test results confirm this requirement is met. |
2. Sample sized used for the test set and the data provenance
The document mentions "Transit and functionality testing" and "Usability test results" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These tests would typically involve a smaller number of devices or simulated use cases to verify engineering specifications rather than a large clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of information is typically related to clinical studies or evaluations where expert consensus defines a "ground truth" for diagnostic or prognostic outcomes. The testing described here is focused on the device's mechanical performance and usability, not clinical efficacy or diagnostic accuracy.
4. Adjudication method for the test set
Not applicable, as no clinical test set for ground truth establishment is described.
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
Not applicable. The NeoTract UroLift System is a medical device (implantable transprostatic tissue retractor system) used for treating BPH, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical implant and delivery system, not an algorithm.
7. The type of ground truth used
For the "Transit and functionality testing" and "Usability test results," the "ground truth" would be established by engineering specifications, proper functional operation, and user feedback/observational analysis against defined tasks. It would not be expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
Not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.