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Intended to be a conduit for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures, such as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.

The UroPass Access Sheath is a single use, sterile (EtO sterilized) disposable product. The sheath is made of layers of polyurethane and PTFE with a stainless steel coil sandwiched in between (the coil provides kink resistance). The sheath has a funnel at the proximal end to ease the insertion of an LDPE dilator. The dilator is equipped with a polypropylene luer connector for injection of irrigation or contrast. The dilator is removable from the sheath by means of a clip fixed to the luer connector. The outside of the sheath has a lubricious coating for ease of insertion into the ureter. For ease of visualization, the dilator and sheath are radiopaque. Two holes (suture loops) are incorporated into the funnel to facilitate attachment to surgical drapes for stabilization of the sheath during surgery.

The provided text describes the UroPass® Ureteral Access Sheath, its intended use, and its substantial equivalence to predicate devices for 510(k) clearance. However, it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, or specific study types based on the provided input. This type of information is typically found in detailed design verification and validation reports, which are not part of the 510(k) summary provided.

The document states: "The fundamental technology of the modified device has not changed. The UroPass Ureteral Access Sheath remains a ureteral access sheath that permits direct passage of catheters, endoscopes and other devices through the urinary tract. The UroPass Ureteral Access Sheath is substantially equivalent in design, materials and intended use to previously cleared devices." This indicates that the clearance was based on similarity to already approved devices, not necessarily a new clinical study with specific acceptance criteria.

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