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The Navigator™ HD Ureteral Access Sheath Set 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.

The Navigator ™ HD Ureteral Access Sheath Set is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device exchanges. Like all ureteral access sheath sets, Navigator™ HD also protects the ureter during device exchanges, thus helping reduce tissue trauma. This set consists of two components: an inner tapered semirigid dilator and an outer semi-rigid sheath. The outer sheath fits over the inner dilator, and the design of the hub allows the dilator to lock into the sheath. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. The device is offered in three French sizes, 11/13 Fr, 12/14 Fr and 13/15 Fr, in lengths up to 46cm. The Navigator ™ HD Ureteral Access Sheath Set is intended for single use only.

The provided text is for a 510(k) summary for a medical device called the "Navigator™ HD Ureteral Access Sheath Set" by Boston Scientific. The information pertains to the regulatory submission process and describes the device's characteristics and intended use, comparing it to a predicate device.

Crucially, this document does NOT describe a study that involves an AI or software algorithm, nor does it provide performance metrics in the way you've requested for an AI/software-based device.

The "Performance Testing (Bench Evaluation)" section refers to physical bench tests conducted on the device, such as "Dilator Tip Weld / Shaft Integrity" and "Flexible Tip Weld Integrity (Durability)", to support the addition of a flexural durability specification. This is a hardware device, not a software or AI device.

Therefore, I cannot provide details on:

• Acceptance criteria and reported device performance related to AI/software metrics.
• Sample sizes for test sets, data provenance, or ground truth establishment for AI/software.
• Number of experts, their qualifications, or adjudication methods for AI/software ground truth.
• MRMC comparative effectiveness studies or standalone AI performance.
• Sample size or ground truth for a training set for an AI/software algorithm.

In summary, the provided document does not contain the information requested as it describes a physical medical device (a ureteral access sheath) and its bench testing, not an AI or software-based device.

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