(77 days)
The Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically, fluoroscopically or during an open surgical procedure by a trained physician.
The Tria Firm Ureteral Stent consists of the following:
- Tria™ Firm Ureteral Stent with retrieval line
- Ureteral Stent Positioner
- Pigtail Straightener
The provided text is a 510(k) Summary for a medical device (Tria Firm Ureteral Stent) seeking substantial equivalence to a predicate device. This document describes performance testing of the device itself (a ureteral stent), not a diagnostic algorithm or AI system.
Therefore, the requested information (acceptance criteria for an AI system, study details like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this document because it is not relevant to the type of device being described.
The document discusses performance testing related to the physical properties of the stent, such as:
- Removal Force
- Renal Coil Strength
- Tapered Renal Tip
- Retrieval Line to Stent Shaft Tensile Strength
- Appearance and Cleanliness
- Reversibility of Tip Configuration
- Column Strength
- Stent Softens at Body Temperature
- Surface Roughness
- Stent Identification Markers
- Guidewire Compatibility
- Biocompatibility
These tests ensure the physical device functions as intended and is biocompatible. They are not metrics for an AI system's diagnostic accuracy or performance.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).