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HORIZON® is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The HORIZON® TMS Therapy System with Navigation (HORIZON®) is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.

HORIZON® is an integrated system consisting of a combination of hardware, software, and accessories.

The provided document focuses on the 510(k) summary for the Magstim HORIZON® TMS Therapy System with Navigation (K183376). This submission is for a medical device (Transcranial Magnetic Stimulation System) for the treatment of Major Depressive Disorder. The document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm's performance, as the device is not described as an AI/ML product.

The document details the device's substantial equivalence to predicate devices based on technological characteristics, intended use, and non-clinical testing (electrical safety, EMC, biocompatibility, and software verification/validation). It does not describe performance metrics related to diagnostic accuracy, sensitivity, specificity, or other typical AI/ML acceptance criteria.

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and performance study details for an AI/ML device from the provided text. The device described is a hardware-based system with associated software, not an AI/ML algorithm.

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