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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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Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include:

• 1. Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection.
• 2. Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures.
• 3. Hemostasis control of bleeding, epilation, and telangiectasia.
• 4. Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis.
• 5. Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.

Not Found

I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter from the FDA for the "Wallach Quantum 500 Electrosurgical Generator."

While it lists the indications for use of the device, it does not include any information about:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Any study design, data, or results that demonstrate the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or ground truth methodologies.
• Whether MRMC or standalone performance studies were conducted.

The letter primarily communicates the FDA's finding of substantial equivalence based on a submission (K983208), but the details of that submission, including performance studies, are not present in the provided document.

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