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MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15-21).

The MagVenture TMS Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp.

The pulses generate an electric field in the underlying brain tissue. When this field surpasses a specific threshold and aligns appropriately with the brain's neuronal pathways, it induces localized axonal depolarization, leading to neuron activation in the targeted brain region.

The MagVenture TMS Therapy System represents an integrated system comprised of the following components:

• Magnetic Stimulator (MagPro Family)
• Coil for motor threshold determination: C-B60, C-B70
• Treatment Coils: Cool-B65, Cool-B70, Cool D-B80
• Accessories:
  • Trolley with mounting for super flexible arm and coil holder arrangement)
  • Patient head fixation
  • Super flexible arm or Flow Arm for coil fixation
  • Isolation transformer
  • Cooler Unit
  • Caps and Marking accessory (marking plate, pen, ruler) – Beam F3 or 5.5 cm Coil Placement
  • Vacuum pump and Vacuum pillow with Pillow Case for patient head fixation (Optional)
  • Treatment Chair (Optional)
  • Coil Hub (Optional)
  • MagVenture TMS Atlas Neuro Navigation System (Optional)

Except for the Beam F3 marking plate, all components have previously received FDA clearance. The MagVenture TMS Therapy System and its technological characteristics remain equivalent to those cleared under K150641, K170114, K171481, K171967, K172667, K173620.

This submission introduces the following modifications:

• Expanded Indications: MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21)
• Coil Approval Expansion: Inclusion of Cool D-B80 for MDD in adolescent patients (age 15-21).
• Beam F3 Marking Method: Introduces the Beam F3 marking plate as an alternative to the standard 5.5 cm method for coil positioning in the dorsolateral prefrontal cortex (DLPFC).

Apart from the modifications outlined above, the core design, fundamental operating principles, and safety characteristics remain substantially equivalent to the previously cleared MagVenture TMS Therapy System.

The provided FDA 510(k) clearance letter and associated summary pertain to the MagVenture TMS Therapy System. However, this documentation does not describe an acceptance criteria table or a study that specifically proves the device meets such criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for the treatment of Major Depressive Disorder (MDD) in adolescent patients, expanding indications, and introducing a new coil positioning method. It highlights non-clinical performance testing against electrical safety and performance standards (e.g., IEC 60601-1) and a clinical literature review to support safety and effectiveness.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML enabled medical device, as the provided text relates to a Transcranial Magnetic Stimulation (TMS) system, which is a hardware-based therapy device, not an AI/ML diagnostic or prognostic tool.

The questions you've asked are highly relevant for the clearance of AI/ML medical devices (e.g., in medical imaging or diagnostics), which require rigorous validation of their algorithmic performance. The provided document does not contain this information because the MagVenture TMS Therapy System is not an AI/ML enabled device.

To answer your request accurately, based on the provided text, I can only state that the document does not contain the information required to populate the fields related to AI/ML device acceptance criteria and validation studies.

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