(260 days)
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.
The Fusion® OMNI Sphincterotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high- frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.
The provided text describes a 510(k) premarket notification for a medical device (Fusion® OMNI™ Sphincterotome), not an AI/ML-based medical device. Therefore, the information required to answer the questions regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML performance is not present in the provided document.
The document focuses on demonstrating substantial equivalence to a predicate device through:
- Identical Intended Use: The Fusion® OMNI™ Sphincterotome has the same intended use as the predicate device (Wilson-Cook OMNI™ Sphincterotome).
- Minor Technological Differences: These differences (e.g., catheter diameters, wire guide port, slightly decreased voltage) are deemed not to raise new questions of safety and effectiveness.
- Performance Data: This section details non-clinical bench testing, sterilization, shelf life, biocompatibility, and electrical safety/EMC testing, all of which are standard for traditional medical devices to ensure they perform as intended and safely.
There is no mention of an algorithm or AI/ML components, nor any studies that would involve human readers, ground truth established by experts for image interpretation, or training/test sets as would be required for such devices.
Therefore, I cannot provide the requested table or answer the specific questions about AI/ML device performance and validation based on the provided text.
§ 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).