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The UASS is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access.

The UASS is designed to create a conduit for urological procedural instruments. This set consists of two components: an inner tapered semi-rigid dilator and an outer more flexible sheath. The outer flexible sheath fits over the semi-rigid inner dilator and it may be locked into place. These components are radiopaque and have a lubricous coating UroGlide™. The device is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths up to 49cm.

The UASS may be placed retrograde and/or antegrade. To guide the access sheath into the body orifice the dilator is advanced over up to a .038" guidewire. The device can be visualized under xray (fluoroscopy) during placement to confirm location. The proposed device can accept other urological instrumentation with OD's compatible with the sheath's working channel of 11 and 13 Fr, respectively.

The proposed device is provided sterile single use. The packaging materials used for the proposed UASS are commonly used materials for packaging medical devices and similar to the predicate devices. The device will be packaged in a labeled, single mylar and tyvek peel pouch, which will be placed in a labeled, paperboard shelf carton.

I am sorry, but based on the provided document, I cannot find the information requested regarding acceptance criteria and the study that proves the device meets them. This document is a 510(k) substantial equivalence letter for the UASS (Ureteral Access Sheath Set). It focuses on regulatory approval based on demonstrating equivalence to predicate devices, rather than presenting detailed study results against specific performance acceptance criteria.

The document discusses:

• The device name and its regulatory classification.
• The determination of substantial equivalence to predicate devices.
• General regulatory requirements for the device.
• Indications for Use.
• A summary of safety and effectiveness, including device description and intended use.

It does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or expert qualifications for a test set.
• Details on adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance data.
• The type of ground truth used or details about training set size and ground truth establishment.

The purpose of this type of FDA document is to formally communicate the FDA's decision regarding substantial equivalence for marketing, not to provide the underlying performance studies in detail.

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