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The Bard X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

The Bard X-Force™ Nephrostomy catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a radiopaque band which corresponds with the distal end of the balloon's working length to facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus,

The provided text is a 510(k) Summary for the X-Force™ N30 Nephrostomy Balloon Dilation Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance as would be expected for a novel device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader studies, standalone performance, and training set details is not present in the provided document.

Instead, the document states:

• "The modified device has the same intended use, general design and fundamental scientific technology as the predicate device."
• "The X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted."

This indicates that the device's acceptance was based on demonstrating that it meets the same specifications and performance as existing, legally marketed devices, following standard engineering and manufacturing verification and validation processes, rather than a clinical trial with specific performance metrics defined by an acceptance criterion.

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