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The RELIEF™ Ureteral Stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture. malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. The stent is not intended as a permanent indwelling time should not exceed thirty (30) days.

The RELIEF™ Ureteral Stents are sterile, single-use devices. The stents are available in 6Fr, with lengths of 24cm and 26cm. The ureteral stent is constructed of a radiopaque polymer tube with a central lumen with side holes positioned along its length to provide drainage of urine from the kidney to the bladder and includes hydrophilic coating. Along the stent are printed insertion markers throughout its length. The stent includes a radiopaque soft polymeric proximal tubular coil and body segment attached to a 4 cm tether of suture material that is placed along the ureter intramural segment, allowing natural opening, and closing of the ureteral orifice. The tether is attached to a radiopaque distal bladder coil constructed of a monofilament (non-lumened), polymeric segment, allowing it to float in the bladder, thus precluding any tension on the tether or coil. The RELIEF™ Ureteral Stent package contents consist of: RELIEF™ Ureteral Stent, Stent pusher tube with radiopaque tip, Pigtail straightener. The RELIEF™ Ureteral Stent is not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days only). The following models are available for the subject device: RS-001: 6Fr x 24cm, RS-002: 6Fr x 26cm.

The provided document is a 510(k) summary for the RELIEF Ureteral Stent Kit. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and bench testing. It does not describe a study involving an AI/ML device, nor does it provide the detailed information requested regarding AI model acceptance criteria, test set specifics (sample size, provenance, expert ground truth, adjudication), MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill the request as the necessary information (an AI/ML device study) is not present in the provided text. The document is for a physical medical device (a ureteral stent), not a software or AI/ML product.

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