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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:

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.

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