Search Results

The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Ampa One System is a computerized, electromechanical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons.

The Ampa One System is an integrated system composed of the following hardware and software components with associated functions to enable its intended use:

• . Ampa L and M Coils - MT determination and Depression treatment
• . Bridge Box & cables - Allows connection to the pulse generator and control treatment protocols from the pulse generator and Ampa tablet with software
• Ampa tablet with software - The software interface for operators to control TMS treatment
• . Ampa Magic Arm - Support system to securely hold the coils in place during treatment
• Neuronavigation Cap Fabric cap worn by patient with integrated markings for determination of . cerebral cortex treatment targets

The system is intended to be used with the MagVenture MagPro R30 Pulse Generator (K230014) and cannot be used without a compatible pulse generator.

The system comes with a tablet preloaded with a mobile app containing the software interface for operation of the system.

The provided document is a 510(k) Summary for the Ampa One System, a repetitive transcranial magnetic stimulation (rTMS) device. While it details the device description, intended use, and a comparison to predicate devices, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.

This document focuses on demonstrating substantial equivalence to existing predicate devices, which is a different regulatory pathway than requiring novel clinical studies to prove effectiveness against a predefined set of acceptance criteria. For devices demonstrating substantial equivalence, the focus is on showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the information required to populate the tables and answer the questions (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary. The document primarily discusses non-clinical testing for safety (function and compatibility) and effectiveness (magnetic characteristics) by comparing them to predicate devices, asserting equivalence rather than demonstrating performance against a specific set of acceptance thresholds.

Ask a specific question about this device