(259 days)
These instruments have been designed to be used with an Olympus endoscope for papillotomy and for dilating the major papilla to retrieve biliary stones.
The subject device consists of the balloon and the papillotomy knife for endoscopic sphincterotomy. The predicate device consists of a closed guidewire lumen, and the subject device consists of a partially open quidewire lumen. The partially open guidewire lumen is called the C-Channel design, and the exchange operation of the quidewire is added.
The provided text describes a 510(k) premarket notification for a medical device called the "Single Use Balloon Dilator V (with Knife)". The document focuses on demonstrating substantial equivalence to predicate devices and provides a summary of non-clinical testing performed.
However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of statistical performance metrics, such as sensitivity, specificity, accuracy, or other commonly used metrics for evaluating AI/algorithm performance. It is a regulatory submission for a physical medical device.
Therefore, I cannot provide the requested information from the given text. The document details engineering and performance tests relevant to the physical characteristics and safety of a medical device, not the performance of an AI or algorithm in the way your prompt specifies (e.g., "human readers improve with AI vs without AI assistance").
If this were an AI/algorithm-based device, the 510(k) summary would typically include detailed clinical study results with statistical endpoints to demonstrate effectiveness and safety, and direct comparisons to human readers or ground truth established by experts.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).