(184 days)
The expandable sheath is designed especially for formation of large nephrostomy tracts required for percutaneous removal of renal and ureteral calculi.
Not Found
This FDA Premarket Notification (510k) provides no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is generally about the FDA's decision to clear the device for market based on substantial equivalence to a predicate device, rather than providing detailed performance study results from the manufacturer.
Therefore, I cannot provide the requested information from the given text.
If this were a document that contained such a study, I would look for sections detailing:
- Performance Data: Tables or descriptions of metrics like sensitivity, specificity, accuracy, etc.
- Study Design: Information on how the study was conducted, including sample size, data collection methods (retrospective/prospective), and data origin.
- Ground Truth Establishment: Details on how the "correct" answers were determined, including the number and qualifications of experts, and adjudication methods.
- Comparative Studies: Mention of MRMC studies or other comparisons to human performance.
- Training Data: If an AI device, details on the training set size and ground truth establishment for training.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).