(30 days)
The MagVita TMS Therapy - w/MagPro R20 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The MagVita TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The Mag Vita TMS Therapy System is indicated for Treatment of Major Depressive Disorder 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.
In the MagVita TMS therapy system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the Mag Vita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).
The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components:
- MagPro Stimulator and Trolley .
- Coils for MT determination and Depression Treatment .
- Marking apparatus for locating treatment area
- Patient head fixation .
- Isolation Transformer .
The difference between the cleared MagVita TMS Therapy w/MagPro R20 and the modified MagVita TMS Therapy w/MagPro R20 (this submission) is the replacement of the two MCF-B65 coils with one MCF-B70 coil.
The provided text is a 510(k) Summary for a medical device (MagVita TMS Therapy w/MagPro R20) and does not describe a study involving an AI/algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested fields related to AI/algorithm performance and study design cannot be extracted.
The document primarily discusses the device's technical specifications and a comparison to an earlier version of the same device. The "performance" mentioned in the acceptance criteria refers to the physical output characteristics of the transcranial magnetic stimulation (TMS) device, not the performance of an AI algorithm in clinical tasks like diagnosis or image interpretation.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Device) | Conclusion |
|---|---|---|---|
| Performance | Waveforms: Biphasic | ||
| Frequency: 0.1 - 20 pulses per second. | |||
| Preset range of % MT: 50%-140% | |||
| Recommended standard treatment: Stimulation Intensity: 120% MT | |||
| Repetition rate: 10 Hz | |||
| Train duration: 4 sec | |||
| Interval between pulses: 26 sec | |||
| Numbers of pulses/session: 3000 | |||
| Output Stimulation Parameters: Available Stimulation Amplitude in Standard Motor Threshold (SMT) units | |||
| Amplitude Range: 0 - 1.2 SMT | Waveforms: Biphasic | ||
| Frequency: 0.1 - 20 pulses per second. | |||
| Preset range of % MT: 50%-140% | |||
| Recommended standard treatment: Stimulation Intensity: 120% MT | |||
| Repetition rate: 10 Hz | |||
| Train duration: 4 sec | |||
| Interval between pulses: 26 sec | |||
| Numbers of pulses/session: 3000 | |||
| Output Stimulation Parameters: Available Stimulation Amplitude in Standard Motor Threshold (SMT) units | |||
| Amplitude Range: 0 - 1.2 SMT | Identical | ||
| Pulse width: 290 µs (±5%), Biphasic sinusoid waveform. | Pulse width: 290 µs (±5%), Biphasic sinusoid waveform. | (Identical implies within acceptance criteria) | |
| Frequency Range: 0.1-20 pps (±2%) | Frequency Range: 0.1-20 pps (±2%) | (Identical implies within acceptance criteria) | |
| Coil Configuration & Cooling | Figure-of-eight coil | ||
| Coil MCF-B65 | |||
| Liquid cooling | Figure-of-eight coil | ||
| Coil MCF-B70 | |||
| Liquid cooling | Substantial equivalence of magnetic field properties is documented in Appendix A. | ||
| Design | The system consists of: 1. Mobile console, 2. System software with GUI, 3. Coil positioning system, 4. Coil for MT and coil for treatment, 5. Coil Fixture, 6. Treatment chair, 7. Head support system | The system consists of: 1. Mobile console, 2. System software with GUI, 3. Coil positioning system, 4. Coil for MT and coil for treatment, 5. Coil Fixture, 6. Treatment chair, 7. Head support system | (Implied identical for other components) |
| Standards met | Company complies with ISO 13485:2012 | Company complies with ISO 13485:2012 | Identical |
| Electrical safety | Complies with IEC60601-1, IEC60601-1-1 and IEC60601-1-2. | Complies with IEC60601-1, IEC60601-1-1 and IEC60601-1-2. | Identical |
Study that proves the device meets the acceptance criteria:
The document describes a "Non-Clinical performance data" section, stating: "The non-clinical performance testing of the components of the Mag Vita TMS Therapy System has been tested as required, and cleared by the FDA earlier on K170114. These tests demonstrate that the MagVita TMS Therapy System is safe and effective for use in treatment of Major Depressive Disorder."
For the modified device (this submission, K172667), the study primarily focused on demonstrating substantial equivalence to its predicate device (K170114), specifically concerning the change from the MCF-B65 coil to the MCF-B70 coil. The document indicates that "Substantial equivalence of magnetic field properties is documented in Appendix A enclosed in section 12." This suggests that the study involved comparative testing of the magnetic field properties of the new coil against the previous coil to ensure they are substantially equivalent.
Regarding AI/Algorithm-specific information:
Since this document pertains to a hardware medical device (Transcranial Magnetic Stimulator) and its modification, there is no mention of an AI/algorithm being tested or evaluated in this context. Therefore, the following points cannot be addressed from the provided text:
- Sample size used for the test set and the data provenance: Not applicable, as no AI algorithm is being evaluated. The "test set" would refer to performance data for the physical device components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For regulatory approval of a physical device, ground truth relates to meeting technical standards and functional performance specification. For substantial equivalence, it's about matching the predicate device's established safety and effectiveness.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.