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The Dornier Hoover Negative Pressure Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

The Dornier Hoover Negative Pressure Access Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. It is for the passage of endoscopes and other urological devices for Ureteroscopy and used for the treatment of stones and for the removal of foreign bodies in the urinary tract.

The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic- coated guide sheath with joint.

The guide sheath is fitted with a Y connector on the Y connector is bifurcated straight tube and oblique tube. One segment of the Y connector is straight and is contiguous with the sheath. The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure.

A dilator is included for the insertion of the dilator is radiopaque and is fitted with a hand buckle on the proximal end. The dilator can be locked to the proximal end of the straight tube using a locking mechanism.

The Dornier Hoover Neqative Pressure Access Sheath is reinforced with a stainless-steel coil, constructed of a medical grade thermoplastic elastomer. All colorants used are compliant with FDA standards.

The device is offered of inner diameter in French size 10Fr, 12Fr and length 40cm, 50cm. The device is supplied sterile and intended for single use only.

The Dornier Hoover Neqative Pressure Access Sheath has six different models. The structural composition and materials of the different models are identical. The only difference is in dimension including inner diameter, and length.

I am sorry, but the provided text does not contain specific acceptance criteria, detailed study information, or performance metrics for the Hoover Negative Pressure Access Sheath.

The document is a 510(k) premarket notification letter and summary for a medical device. It states that non-clinical performance bench testing was conducted to demonstrate substantial equivalence to a predicate device and that the device meets "pre-determined testing and acceptance criteria." However, it does not specify what those criteria are or provide results in a way that would allow for the construction of the requested table and detailed study description.

The text mentions general categories of testing:

• General performance testing: Connection Strengths, Coefficients of Friction, Dimensional Analysis, Fluid Leakage.
• Biocompatibility testing: Cytotoxicity, Irritation, Sensitization.
• Sterilization validation: Conforming to ENISO 11135:2014.

It also indicates that testing data and results demonstrating compliance are "included in this submission," but these specifics are not present in the provided text. Therefore, I cannot furnish the detailed information you've requested regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or any MRMC study details.

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