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Used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques.

The Universa" Soft Ureteral Stents and Stent Sets are flexible, tubular double pigtail stents composed of radiopaque polyurethane. The devices may include a positioner with a radiopaque band, a pigtail straightener, or a wire guide. Alternatively, these sets may include only a positioner and a pigtail straightener. The Universa" Soft Ureteral Stents and Stent Sets are 5.0 to 8.0 Fr in diameter and from 8.0 to 30.0 cm in specified length. The stents are also available in expandable multi-length versions, with diameters of 5.0 to 8.0 Fr and can accommodate ureter lengths ranging from 22.0 to 32.0 cm.

The provided text is a 510(k) summary for a medical device (Universa Soft Ureteral Stents and Stent Sets). While it lists the types of tests performed to demonstrate reliable design and performance, it does not provide specific acceptance criteria or the reported device performance outcomes for each test. It only concludes that the results support a determination of substantial equivalence to predicate devices.

Therefore, I cannot populate a table with acceptance criteria and reported device performance.

Likewise, the document does not describe a study involving:

• Sample sizes used for a test set or data provenance (country, retrospective/prospective).
• Number or qualifications of experts to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

This is because the device in question is a ureteral stent, which is a physical medical device, not an AI/software as a medical device (SaMD) that would typically involve such studies for performance evaluation. The listed tests (Tensile testing, Break strength, Biocompatibility, Curl retention, Flow rate, Ink adherence, Dynamic frictional force, Radiopacity, MRI testing) are physical and material property tests designed to demonstrate the device's safety and performance in its intended physiological environment.

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