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TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.

TURBT- RF electrodes and Electrosurgical devices

I'm sorry, but the provided text is a 510(k) clearance letter from the FDA to Prosurg, Inc. for "TURBT-RF electrodes and Electrosurgical devices." This document primarily discusses the regulatory approval of the device based on substantial equivalence to predicate devices. It does not contain any information regarding:

• Acceptance criteria or reported device performance for a study.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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