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electrosurgical probes and devices are to be used with The commercially available R.F. generators, endoscopes including laparoscopes, hysteroscopes, resectoscopes, cystoscopes and suction/irrigation systems. These devices can be used for lappeoscopic. hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.

Isolated Electrosurgical Probes & Devices-Salinetrode™M (cutting loops, roller balls, roller bars/barrels, and needles/blades)

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The document is an FDA 510(k) clearance letter for an electrosurgical device, confirming its substantial equivalence to a predicate device and outlining regulatory information. It does not include data from a clinical or performance study.

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The electrosurgical probes and devices are to be used with commercially available R.F. generators, endoscopes including hysteroscopes, resectoscopes, cystoscopes and laparoscopes, suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.

Electrodes/Probes/Devices

This is a 510(k) premarket notification letter from the FDA to Ximed Medical/ProSurg, Inc. regarding their "Electrodes/Probes/Devices."

The document states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to predicate devices. This letter approves the device for marketing.

However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The information provided (K974637) is a regulatory approval document, not a clinical study report or a performance specification document. Therefore, I cannot extract the requested information from the provided text.

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