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VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. With the aid of a ureterocystoscope, a radiopaque medium is injected into the ureter for radiologic imaging.

The VOMED urethra olives are accessories of male urethrographic catheters. They are placed temporarily on the external end of the penis to guide the insertion of the catheters and to facilitate the injection of the opaque substance.

The devices are indicated for diagnostic and therapeutic urologic procedures.

VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. They are accessories of male urethrographic catheters.

The provided text is a 510(k) summary for VOMED Urethra Olive Models. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a letter from the FDA determining substantial equivalence for the specified device. It focuses on regulatory aspects such as classification, general controls, and compliance with the Federal Food, Drug, and Cosmetic Act. It also includes the official "Indications for Use" for the VOMED Urethra Olives.

Therefore, I cannot extract the requested information from the provided text.

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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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