(140 days)
Instrument for flexible endoscopy for dissection by blunt spreading of tissue and hemostasis in the gastrointestinal tract
Not Found
I am sorry, but the provided text from the FDA document for K141794, "Endo-Maryland Dissector," does not contain information about acceptance criteria, device performance, or any studies as requested in your prompt.
The document is a 510(k) premarket notification letter, which primarily deals with the substantial equivalence determination for a medical device. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls of the Act. It also outlines regulatory requirements and contact information.
To elaborate, the document does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, number of experts, or adjudication methods for any test set.
- Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Details about the type of ground truth used or how ground truth was established for training or test sets.
Therefore, I cannot fulfill your request for this specific device 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).