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The primary indications for use are abnormal uterine bleeding with or without pain, and infertility. Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Müllerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.

VaporTrode™ Vaporization Electrodes in Gynecology

This document is a 510(k) clearance letter from the FDA, and it does not contain the detailed information about acceptance criteria or a study proving device performance as requested. The letter confirms that Circon Corporation's VaporTrode™ Vaporization Electrodes in Gynecology are "substantially equivalent" to legally marketed predicate devices, allowing them to be marketed.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from the provided text. The document is primarily a regulatory approval notification and does not delve into the technical study details.

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