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Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:

1. Cervical Conization.
2. Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
3. External Anogenital Lesions.
4. Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
5. Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.

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This is a 510(k) clearance letter for the Wallach Quantum 500 Electrosurgical Generator. This document does not contain the information requested regarding acceptance criteria and a study proving device performance.

The provided text is a regulatory clearance document from the FDA, indicating that the device is substantially equivalent to legally marketed predicate devices. It outlines the intended use and regulatory classification but does not include details about device performance studies, acceptance criteria, or the methodology of such studies.

Therefore, I cannot provide the requested table and details based on the given input.

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