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The Allwin Ureteral Catheters are used for drainage of urine from the ureter and they allow the delivery of contrast media.

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This document is an FDA 510(k) clearance letter for a medical device (Allwin Ureteral Catheters), not a study report or clinical trial summary. Therefore, it does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It doesn't detail the performance validation methods or results for the device itself.

To answer your request, you would need access to the actual 510(k) premarket notification submission (K220730) which would contain the data from performance testing, if such data was required and submitted for this type of device. However, for a Class II device like a ureteral catheter (product code KOD), performance testing might focus on physical properties, biocompatibility, and sterilization rather than image analysis performance metrics.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and study data for device performance.

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