(70 days)
Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is intended to Electrosurgically Remove and collect Polyps from the Gastro Intestinal Tract Under Endoscopic Visualization.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Horizons Rotatable Snare and Polyp Catcher TORNADO™". This letter confirms substantial equivalence to a predicate device, allowing the manufacturer to market the device.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance). The letter is an administrative communication from the FDA, not a technical report or study summary.
Therefore, I cannot provide the requested table and information based on the given text.
To answer your request, I would need a different type of document, such as:
- A clinical study report
- A performance testing report
- A detailed regulatory submission document (e.g., the 510(k) submission itself, if it included performance data)
In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies.
§ 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).