(142 days)
The Mag Vita TMS Therapy System 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 as effective as the predicate device 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 MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).
The MagVita TMS Therapy System is an integrated system consisting of the following components:
- MagPro Stimulator and Trolley
- Coil for MT determination
- Marking apparatus for locating treatment area
- Patient head fixation
- Coil for Depression Treatment
- Isolation Transformer
The provided text is a 510(k) summary for the MagVita TMS Therapy System. It states that the device is substantially equivalent to a predicate device (NeuroStar TMS Therapy System) and therefore does not require new acceptance criteria or a new study to prove its efficacy. Instead, it relies on the established safety and effectiveness of the predicate device.
Therefore, the document does not contain the specific information requested about acceptance criteria and a new study proving the device meets those criteria for the MagVita TMS Therapy System itself. It instead focuses on demonstrating substantial equivalence to a previously cleared device.
However, I can extract information related to the comparison of the two devices and their intended use, which might indirectly address some of your points as they relate to the predicate device's established performance.
Here's an analysis based on the provided text, extrapolated to address your request where possible, but with the critical caveat that this document does not present de novo acceptance criteria or a new study for the MagVita TMS Therapy System.
1. Table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission, there are no new acceptance criteria defined in this document for the MagVita TMS Therapy System. Instead, the performance is compared to the predicate device, aiming to show similar or equivalent performance parameters.
| Parameter | MagVita TMS Therapy System Performance (Reported for comparison) | NeuroStar TMS Therapy System Performance (Predicate) |
|---|---|---|
| Waveforms | Biphasic | Biphasic |
| Frequency | 0.1 - 30 pulses per second or 0.1 - 100 pulses, depending on model | 0.1 - 30 pulses per second |
| Preset range of % MT | 0% - 140% | 80% - 140% |
| Recommended standard treatment: Stimulation Intensity | 120% MT | 120% MT |
| Recommended standard treatment: Repetition rate | 10 Hz | 10 Hz |
| Recommended standard treatment: Train duration | 4 sec | 4 sec |
| Recommended standard treatment: Interval between pulses | 26 sec | 26 sec |
| Recommended standard treatment: Numbers of pulses/session | 3000 | 3000 |
| Output Stimulation Parameters: Amplitude Range | 0 - 1.7 SMT | 0.22 - 1.6 SMT |
| Output Stimulation Parameters: Pulse width | 290 $\mu$s (±5%), Biphasic sinusoid waveform | 185 $\mu$s (±10%), Biphasic sinusoid waveform |
| Output Stimulation Parameters: Frequency Range | 0.1-30 pps (±2%) or 0.1-100 pps, depending on model | 0.1-30 pps (±2%) |
| Coil Configuration | Figure-of-eight coil, Air core | Figure-of-eight coil, Ferromagnetic core |
| Cooling | Liquid cooling | Ferrofluidic cooling |
2. Sample size used for the test set and the data provenance:
The document states that "The non-clinical performance testing of the components of the MagVita TMS Therapy System has been tested as required, and cleared by the FDA earlier on K061645, K071821 and K091940." It further mentions that "These tests along with the supportive clinical information from the predicate device demonstrate that the MagVita TMS Therapy System is as safe and effective as the predicate device."
This implies that no new clinical study (test set) for the MagVita TMS Therapy System's efficacy in treating Major Depressive Disorder was conducted for this 510(k) submission. The submission relies on the existing clinical data and regulatory clearance of the predicate device (NeuroStar TMS Therapy System) and previous clearances of MagVita TMS Therapy System components. Therefore, information about sample size, country of origin, and retrospective/prospective nature for a new test set for efficacy is not present in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no new clinical efficacy test set was conducted for this 510(k) submission.
4. Adjudication method for the test set:
Not applicable, as no new clinical efficacy test set was conducted for this 510(k) submission.
5. 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. This device is a Transcranial Magnetic Stimulator, not an AI-powered diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a therapeutic device, not an algorithm. Its performance is measured directly by its physical output (magnetic fields) and its therapeutic effect, which is established by clinical trials for the predicate device.
7. The type of ground truth used:
For the predicate device, the ground truth for its efficacy would have been established through clinical trials, likely involving patient outcomes data (e.g., reduction in depression symptom scores as measured by standardized clinical scales) and expert consensus from diagnosing clinicians. This document specifically states the indication for the predicate (and thus the new device) is for "treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode," implying that clinical improvement in depressive symptoms is the primary measure of efficacy.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device. The "training set" for a medical device's performance would refer to the data used to validate its design and manufacturing. The document refers to non-clinical performance testing and previous clearances of components (K061645, K071821, K091940), which would have involved their own testing samples.
9. How the ground truth for the training set was established:
Not applicable for a "training set" in the AI sense. For the non-clinical performance testing mentioned, the "ground truth" would be established by predefined engineering and safety specifications and measurements (e.g., magnetic field strength, pulse width accuracy, frequency control).
§ 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.