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The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.

The Dfiner Urological Catheter is a dual lumen flexible co-axial catheter. The main lumen contains a flexable sheath which houses is a solid flexible rod. Attached to the distal end of the rod is an array of wires. The wire bundle can be advanced and deployed in the bladder to assist with anatomical imaging. Contrast material is introduced through the main lumen. The catheter has a rigid "Y" connector at the proximal end that allows the wire bundle/sheath to be deployed/retracted and access to the main lumen.

The provided text is a 510(k) Summary for the Dfiner Urological Catheter. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML medical devices.

The document describes a traditional medical device (a catheter) and references a "comparison of technological characteristics" to predicate devices, rather than a clinical performance study with acceptance criteria, sample sizes, ground truth, or expert involvement.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to already legally marketed devices based on design, intended use, and materials of manufacture, not on the performance of an AI algorithm.

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