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The MECTA Sigma ECT device is for use in treating catatonia or severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years or older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

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The provided document is an FDA 510(k) clearance letter for the MECTA Sigma Electroconvulsive therapy (ECT) device. It does not contain information about acceptance criteria, device performance, or studies that prove the device meets specific criteria (such as a clinical trial report or a comprehensive performance study).

The document states that the device is substantially equivalent to legally marketed predicate devices. This equivalence determination by the FDA typically means that the new device has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.

Therefore, I cannot provide the requested information based on the given text. A 510(k) clearance letter is a regulatory document, not a scientific study report detailed enough to answer the specific questions about acceptance criteria, study design, and performance metrics.

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