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The MagVita TMS Therapy System w/ Theta Burst Stimulation 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 w/Theta Burst Stimulation 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. The MagVita TMS Therapy System w/ Theta Burst Stimulation is indicated for the treatment of 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 standard-of-care FDA approved TMS protocol for treatment of MDD uses repetitive transcranial magnetic pulses applied at a frequency of 10 Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10 Hz rTMS) repetitive TMS (rTMS) has been shown to persist beyond the duration of the train of stimulation, and 10 Hz rTMS on the Left-Dorsolateral prefrontal cortex (L-DLPFC) has been shown to be effective and safe in the treatment of MDD. A newer form of the TMS, called intermittent Theta Burst Stimulation (iTBS), mimics the endogenous theta rhythms of the human brain, and has been shown to evoke equally potent excitatory effects. Intermittent TBS provides bursts of three individual stimuli at a rate of 50 Hz (i.e. 20 ms apart), repeated at 5 Hz (i.e. 200 ms between burst) mimicking the theta rhythm of the brain. Thus, the iTBS protocol is more demanding in terms of stimulator output. The clinical performance is based on the fact that the actual individual stimuli are of equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.

MagVita TMS therapy system w/Theta Burst stimulation is applied to the human brain of the left dorsolateral prefrontal cortex (L-DLPFC) using iTBS.

The MagVita TMS Therapy System w/ Theta Burst Stimulation is an integrated system consisting of the following components:

• MagPro Stimulator and Trolley .
  • o MagPro family
  • Trolley with holding arrangements o
• Coil for MT determination and Depression treatment .
  • o Coil Cool-B70 with Coil Cooler Unit
• Marking apparatus for locating treatment area .
  • Marking plate for Coil Cool-B70 o
  • Pen for marking, Cap, Ruler o
• Patient head fixation .
  • Treatment Chair o
  • Vacuum Pump and Vacuum pillow o
  • Super Flexible Arm mounted on the trolley o
• Isolation Transformer .

The provided text describes a 510(k) premarket notification for the MagVita TMS Therapy System with Theta Burst Stimulation. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study designed to prove the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and ground truth establishment cannot be found or directly inferred from the provided document as it is a regulatory submission for product clearance based on substantial equivalence, not a clinical trial report with a defined performance study against specific acceptance criteria.

However, I can extract and infer some information, particularly regarding the clinical evidence used to support the substantial equivalence claim.

Here's an attempt to answer the questions based on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or reported device performance metrics in a table form as would be expected from a device validation study. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices, focusing on similar indications, technological characteristics, safety, and effectiveness.

The closest to "acceptance criteria" are the performance standards the device complies with, which are qualitative:

• ISO 13485:2012
• IEC60601-1
• IEC60601-1-2

The reported device performance is described qualitatively and comparatively:

• "The MagVita TMS Therapy System w/Theta Burst Stimulation, is as safe and effective and performs as well as the predicate devices with enhanced ease of use and reduced treatment time to the benefit of both patient and operator."
• "The clinical performance and effectiveness, as well as tolerability and side effect profile for the new device and the predicate devices are substantially equivalent."
• "the MagVita TMS Therapy System w/Theta Burst Stimulation delivers stimuli of equal intensity, thereby verifying that the dose is maintained throughout the course of treatment." (Non-clinical performance)
• Compliance with permissible sound pressure levels and OSHA exposure thresholds. (Non-clinical performance)
• Magnetic field distribution is "substantially equivalent" to predicate devices. (Non-clinical performance)

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of a dedicated prospective validation study for the new device.

It refers to a "large randomized, multicenter trial" that "demonstrated the effectiveness, safety and tolerability of iTBS." This trial likely involved a sample size of patients, but the specific number is not provided.

The data provenance for this trial is not stated (e.g., country of origin, retrospective/prospective). However, given it's a "randomized, multicenter trial," it implies a prospective design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document relies on the findings of a pre-existing "large randomized, multicenter trial" that established the clinical effectiveness of iTBS generally, and then argues that the MagVita system implementing iTBS is substantially equivalent to existing 10 Hz rTMS systems. Clinical outcomes from the trial (e.g., improvement in MDD symptoms) would serve as the ground truth, but how they were established or by whom (e.g., expert raters) is not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

An MRMC study is relevant for imaging devices or AI tools where human readers interpret data. This device is a Transcranial Magnetic Stimulation system for therapeutic treatment, not an AI or imaging diagnostic device. Therefore, an MRMC study is not applicable and was not performed. The "comparative effectiveness" mentioned refers to the effectiveness of iTBS compared to 10 Hz rTMS, not human performance with/without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to a device that is autonomous (e.g., an AI algorithm). This device is a therapeutic system that requires operator setup and patient interaction. Therefore, a "standalone algorithm-only" performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the safety and effectiveness of iTBS in general, the "ground truth" was likely based on patient outcomes data from the "large randomized, multicenter trial," specifically regarding the "treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode." This would involve clinical assessments of symptom improvement.

For the substantial equivalence claim, the ground truth for specific performance parameters of the MagVita system (e.g., magnetic field distribution, stimulus intensity, sound levels) was established through non-clinical performance testing against physical specifications and standards, as described in the document.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning. The "large randomized, multicenter trial" referenced for clinical performance represents the evidence base for iTBS, not a training set for the MagVita device itself.

9. How the ground truth for the training set was established

As there is no "training set" described in the machine learning sense, this question is not applicable. The clinical effectiveness of iTBS was established through a "large randomized, multicenter trial," which would have had its own methods for establishing the ground truth of patient outcomes (e.g., validated depression scales, clinical interviews). These methods are not detailed in this document.

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