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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

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:

2. 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.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. 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.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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 w/MagPro R20 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 MagVita TMS Therapy w/MagPro R20 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 w/MagPro R20 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 Mag Vita TMS therapy w/MagPro R20 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
  • MagPro R20 o
  • Trolley with holding arrangements o
• Coils for MT determination and Depression Treatment .
  • o Coil MCF-B65
  • Marking apparatus for locating treatment area
    • Marking plate for Coil MCF-B65 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

This document is a 510(k) Summary for the MagVita TMS Therapy w/MagPro R20 device, comparing it to a predicate device, the MagVita TMS Therapy System (K150641).

Based on the provided text, there is no acceptance criteria or study outlined to prove the device meets acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device. This means the manufacturer is asserting the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria and a specific study proving it are not present in this type of FDA submission. Here's what can be inferred or explicitly stated based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there are no explicit "acceptance criteria" presented in the document in the format of a performance study with defined thresholds. The document instead presents a comparison of the new device's performance characteristics to those of the predicate device to demonstrate substantial equivalence.

Implicit Acceptance Criteria: The device is "accepted" if it is shown to be substantially equivalent to the predicate device, meaning its differences do not raise new questions of safety or effectiveness. The document asserts that "all other identified differences between the two systems are minor and without any known impact on safety or efficacy."

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical study with a "test set" in the context of diagnostic accuracy, image interpretation, or treatment efficacy data from the new device. The data presented is a technical comparison of device specifications.

The "non-clinical performance data" section refers to previous FDA clearances for components (K160280 for MagPro R20, K150641 for chair/arm/etc., K071821 for Coil MCF-B65). This indicates that the safety and performance of individual components were evaluated and cleared through separate processes, but it does not represent a specific "test set" for the entire integrated system in a clinical performance study.

Data Provenance: The technical specifications are derived from the device's design and engineering. Any clinical data implicitly relied upon would be from trials that supported the original predicate device's clearance and the understanding of rTMS efficacy for Major Depressive Disorder, not new data for this specific 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not a study requiring expert-established ground truth. The comparison is based on technical specifications and functional equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" or adjudication process described for diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not present an MRMC comparative effectiveness study. The submission is for substantial equivalence based on technical and functional comparison to a predicate device. The device is a therapeutic electromagnetic stimulator, not an imaging or diagnostic device typically subject to MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The device is a therapeutic system with human interaction. While it includes software, it is not an "algorithm only" device in the sense of AI for diagnostic interpretation.

7. The Type of Ground Truth Used

Not applicable in the context of a "ground truth" for a diagnostic or AI performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the existing predicate device and the recognized scientific understanding of repetitive transcranial magnetic stimulation (rTMS) for Major Depressive Disorder as supported by clinical evidence for that class of devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm that undergoes a training phase with a labeled dataset in the typical sense. It is a hardware and software system for delivering a physical therapy.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as point 8.

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MagPro R20 is intended to be used for stimulation of peripheral nerves for diagnostic purposes.

MagPro R20 is a Magnetic stimulator used for Magnetic stimulation. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The MagPro R20 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The MagPro R20 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R20 is controlled via a user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R20 has a built-in computer and 2 small displays. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 20 pulses per second (pps).

The provided text is a 510(k) summary for the MagPro R20 device, comparing it to a predicate device, the MagPro R30. The document focuses on demonstrating substantial equivalence for a medical device rather than proving performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.

Therefore, the requested information about acceptance criteria, study design for AI/algorithm performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for AI devices is NOT available in this document.

The document states:

• The intended use of the MagPro R20 is "stimulation of peripheral nerves for diagnostic purposes".
• The conclusion is that "The MagPro R20 has the same intended use as the predicate device and the same technological features. The MagPro R20 does not raise new issues of safety and effectiveness and is substantially equivalent to the predicate device."

The "Testing" section refers to electrical safety and electromagnetic compatibility (EMC) testing, which are standard regulatory requirements for medical devices to ensure they are safe for use and do not interfere with other equipment. These are not performance studies for a diagnostic algorithm.

Here's a breakdown of why the requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The device is a stimulator, not a diagnostic algorithm with performance metrics like sensitivity/specificity. The document lists physical and functional characteristics for comparison to a predicate, not performance against diagnostic accuracy targets.
2. Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm's diagnostic performance study. The testing mentioned is for electrical safety and EMC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for diagnostic accuracy is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for diagnostic accuracy.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for diagnostic accuracy.
8. The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

This document describes a device approval process based on demonstrating substantial equivalence to a legally marketed predicate device, focusing on similar intended use and technological characteristics, and compliance with safety and EMC standards. It does not involve the type of performance evaluation typically associated with AI/ML diagnostic devices.

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