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The Imager Torque Catheter is indicated for use for catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials.

The Imager Torque Catheter is a single - lumen introduction catheter with a range of tip configurations. The device is flexible catheter with one hole at the tip. A luer lock hub is attached to the proximal end. The catheter is designed to be used with a .038" guidewire if required.

The provided text is a 510(k) summary for a medical device (Imager Torque Catheter). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about performance criteria, study results, or validation data typically associated with AI/ML-driven devices or diagnostic tools.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because the provided text does not contain that type of information.

The 510(k) summary focuses on device description, intended use, and substantial equivalence, which are core elements for regulatory clearance of conventional medical devices, not performance validation studies for AI algorithms.

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