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The Laserscope GDD Cystourethroscope Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological surgery through minimally invasive approach by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra and cold slitting strictures Trans-urethral incision, vaporization, and resection of the prostrate Trans-urethral removal of bladder tumors

The 24 Fr GDD Cystourethroscope is designed with a continuous flow outer sheath, a separate inner sheath/bridge, and an obturator. The outer sheath has the inflow and outflow Stopcocks attached to it. The inner sheath/bridge has one integral accessory port and can accommodate one accessory up to 9 Fr in size. The obturator is designed to allow atromatic introduction of the outer sheath in a natural orfice. The true continuous flow design washes away blood and small tissue particles to ensure a clear operative field. The working length is 23.2 cm to allow access to the entire lower urinary tract. The dedicated operative channel stabilizes accessories including laser fibers. The Continuous Flow Laser Cystourethroscope is designed to be used with low viscosity fluids, including normal saline, Glycine, Sorbitol, or Ringer's Lactate, and standard surgical accessories.

The provided document is a 510(k) summary for the Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories. It explicitly states in section "K. Clinical Data" that "No clinical tests were performed." This means that the submission for this device did not include any studies proving the device meets specific acceptance criteria based on clinical performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this document.

The manufacturer, Laserscope, based their rationale for substantial equivalence and safety on the device sharing "the same Indications For Use, similar design, materials, component features, and functional features" with the predicate device, the Stryker Urology and Gynecology Hardware System. They concluded that "There are no new issues raised regarding the safety or effectiveness of the device."

In summary, the document does not contain the information needed to answer your questions because no clinical studies were conducted for this 510(k) submission.

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