(353 days)
Cysto-Gastro Sets are intended to be used to electrosurgically cannulate pancreatic pseudo-cysts endoscopically (via the transgastric or transduodenal wall) as an alternative to surgical or percutaneous treatment.
Each device is made of an outer flexible Teflon tube equipped with a metal tip at the distal end and an HF (high frequency) connector at the proximal end. Some models included an inner Teflon sheet that slides inside the outer sheet and are equipped with an HF needle at the distal tip and an HF connector at the proximal end.
All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use. There are 5 variations of the Cysto-Gastro Sets with different catheter length and diameter, with or without HF needle. However, all variations are delivered sterile and intended for single use.
The provided text details the 510(k) submission for the Cysto-Gastro Sets device. However, it does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/algorithm-driven device for which the prompt's questions (e.g., number of experts, MRMC studies, training set details) are relevant.
The Cysto-Gastro Sets device is an endoscopic electrosurgical accessory, a physical medical device. The studies described are for non-clinical performance data (bench tests, biocompatibility, sterilization, shelf-life) to demonstrate substantial equivalence to a predicate device, not for evaluating the performance of an AI/algorithm.
Therefore, I cannot provide answers to the requested information as the provided document pertains to a physical device and not an AI/algorithm-driven one. There is no mention of acceptance criteria related to AI performance, ground truth, expert adjudication, or MRMC studies.
In summary, the provided document does not contain the type of AI/algorithm performance data requested.
§ 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).