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The UroLift 2 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 2 System (UL2), most recently cleared in K173087 under the marketing model number of UL500, is comprised of the UroLift Delivery Handle (single patient use), the UroLift Implant Cartridges (singleuse) and the UroLift Implants (one implant per cartridge). Each Implant Cartridge is preloaded with one UroLift Implant. The Implant Cartridges fit into the Delivery Handle. Each patient procedure will use one dedicated Delivery Handle and the number of Implant Cartridges/implants necessary to perform a typical procedure (estimated 2-6 implants). The UroLift 2 System is also provided with an optional Scope Seal which enables a clinician to examine the anatomy between implant deployments without removal of the telescope from the Delivery Handle.

This document, a 510(k) summary for the NeoTract UroLift 2 System (UL2), describes the device and claims substantial equivalence to predicate devices based on various performance and safety tests. However, it does not contain the level of detail requested regarding specific acceptance criteria, reported device performance metrics against those criteria, or clinical study information typically associated with such criteria (e.g., sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).

The available information focuses on non-clinical testing to demonstrate that modifications to the UL2 system do not impact its safety and effectiveness compared to previously cleared versions.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Note: The document explicitly states, "The test methods were equivalent to the previously cleared UroLift System, and all acceptance criteria were met." However, it does not detail what those specific acceptance criteria were or provide quantitative results for the UL2 system against them. The focus is on demonstrating that the modifications did not negatively impact safety and effectiveness, implying the new device meets the same standards as its predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document describes non-clinical performance, biocompatibility, and sterilization testing. It does not mention any clinical test sets with data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. This type of information is usually relevant for studies involving human interpretation or clinical outcomes, not for the non-clinical engineering and biological tests described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Similar to point 3, this is for clinical assessments, not the laboratory testing presented.

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/Not provided. This device is an implantable medical device for treating BPH, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided. The device does not involve an algorithm or AI in the sense of standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implicit ground truth from engineering and safety standards. For non-clinical tests:
  • Product Performance/Compatibility/Deployment: Ground truth implicitly derived from established engineering specifications and functional requirements for the device's design and operation.
  • Biocompatibility: Ground truth is established by the International Standard ISO 10993-1 and related sub-parts, which define acceptable biological responses.
  • Sterilization: Ground truth is a 10⁻⁶ Sterility Assurance Level (SAL), an industry-standard for sterile medical devices.
  • Shelf-life: Ground truth is the ability of the device to function as intended after a specified storage period (12 months).

8. The sample size for the training set

• Not applicable/Not provided. No training set for an algorithm is mentioned as this is a physical medical device.

9. How the ground truth for the training set was established

• Not applicable/Not provided. No training set is mentioned.

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