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The Universa® Firm Ureteral Stent Sets are intended 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® Firm Ureteral Stents and Stent Sets are sterile, single-use devices. The stents are available in 5.0 to 8.0 French (Fr) diameter, with lengths ranging from 18.0 to 32.0 centimeters (cm). The stents are constructed of radiopaque polycarbonate-based polyurethane material and include a hydrophilic coating. Sideports extend along the body of the stent as well as on the pigtails to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. A braided or monofilament tether for repositioning and removal of the device is located on the proximal pigtail (bladder end) of the stent. Along the stent are graduation marks to provide visualization during stent advancement and placement. The Universa® Firm Ureteral Stent includes a pigtail straightener, a small polymer tube to aid in placement over a wire guide. The pigtail straightener is removed prior to use. The stent and pigtail straightener can be sold as a set with a stent positioner and stainless steel wire guide. The positioner and the wire guide are available for sale separately. The Universa Firm Ureteral Stents and Stent Sets are labeled for a 12-month indwell time; however, the tether should be removed after 14 days.

This document is a 510(k) premarket notification for the "Universa Firm Ureteral Stents and Stent Sets." It does not describe a study to prove acceptance criteria for an AI/ML device.

Instead, it pertains to a physical medical device (ureteral stents) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices, thus ensuring its safety and effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets them, as this document is not about AI.

However, I can extract information related to the physical device's testing:

Device: Universa® Firm Ureteral Stents and Stent Sets

Test Data (Not Acceptance Criteria or Performance Values):
The document states that the following tests were performed to assure design and performance under specified testing parameters. It does not provide specific acceptance criteria values or the reported performance values for each test.

• Sterility
• Packaging
• Biocompatibility
• Ink Adherence
• Curl Retention Strength
• Break Strength/Tensile Strength
• Dynamic Friction/Coefficient of Friction
• Flow Rate
• MRI Testing
• Radiopacity

Regarding AI/ML specific questions from your prompt:

• Sample size for the test set and data provenance: Not applicable. This is for a physical medical device, not an AI/ML system.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable in the context of AI/ML. For a physical device, "ground truth" would be established through physical and chemical testing against established standards.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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