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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 UroLift® System UL500 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 patient procedure will use one dedicated sterile handle and the number of cartridges/implants necessary to perform a successful procedure (estimated 2-6 implants). The cartridges fit into the delivery handle. The UroLift Delivery Handles (UL500-H) and UroLift Implant Cartridges (UL500-C) will be sold separately. The UroLift System UL500 Delivery Handles will be sold two per carton and the UroLift System UL500 Implant Cartridges will be sold eight per carton. Both cartons will contain the same UroLift System UL500 Instructions for Use (IFU). The UroLift System UL500 is designed to access the prostatic urethra and deliver one UroLiff Implant through a lateral 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. 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 does not contain information about specific acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, standalone performance, type of ground truth used, or details about the training set for the NeoTract UroLift System UL500.

The document discusses performance testing which included:

• Bench testing (design verification and transit testing) which demonstrated the device meets the same performance requirements as the predicate device.
• Verification of packaging and labeling integrity.
• Bench verification testing of the devices.
• Joint strength testing.
• Design validation performed in a cadaveric model which demonstrated the UroLift System UL500 met customer requirements.
• Biocompatibility testing in accordance with ISO 10993.
• Sterilization and shelf-life testing.

It states that "All acceptance criteria were met" for these tests, but it does not specify what those criteria are or the exact reported performance against those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed information requested in the prompt based on the provided text. The document is primarily a 510(k) summary demonstrating substantial equivalence to a predicate device based on general performance testing categories.

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