(28 days)
The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, III, III , IV.
Not Found
This looks like a 510(k) clearance letter for the Ultroid™ Hemorrhoid Management System. It's a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, not a study report detailing acceptance criteria and performance data.
Therefore, the prompt's request for information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be answered from the provided text.
The document only states the intended use of the device: "coagulative hemostatic therapy of internal hemorrhoids grades I, II, III, IV."
To answer your request, you would need access to the actual 510(k) submission, which would likely include pre-clinical or clinical data to support the substantial equivalence claim.
§ 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).