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To stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older

The MagVenture Pain Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic and post-surgical pain. The subject device is intended to be used in hospitals and clinics such as pain management clinics. The device consists of Magnetic Stimulator, Stimulation Coils, Liquid Cool Unit (optional), and a Trolley. All coils of the MagVenture Pain Therapy have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the skin of the patient or operator. The temperature allowed by the system is maximum 43°C or between 44°C for less than 10 minutes. The system will automatically disable if this maximum temperature is reached.

The provided document is a 510(k) Premarket Notification for the MagVenture Pain Therapy device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness. Therefore, the information regarding specific acceptance criteria and a study proving those criteria are not directly presented in the format requested for a device with novel claims.

However, based on the document, we can infer acceptance criteria from the comparison to the predicate device and the discussion of technological characteristics. The study proving the device meets these inferred criteria is essentially a comparison study against the predicate device and an assessment of why any differences do not raise new questions of safety or effectiveness.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations of a 510(k) submission:

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

The "acceptance criteria" for a 510(k) are typically that the new device is "substantially equivalent" to a predicate device, meaning it has the same intended use and either has the same technological characteristics or, if it has different technological characteristics, those do not raise different questions of safety and effectiveness. The performance is reported by comparing it to the predicate.

The "study" demonstrating these criteria are met is the comparison presented in the 510(k) submission, specifically the "Comparison of Technological Characteristics" table and the "Substantial Equivalence Notes" which explain why differences do not raise new safety or effectiveness questions.

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

The document does not describe a clinical "test set" in the traditional sense of a clinical trial. Instead, the "testing" references non-clinical testing performed on the predicate device (K094019) and the argument that the current device is "identical in all features (e.g., design, dimensions, materials, biocompatibility), except for the indications for use." Therefore, "no new bench testing is needed."

This implies that the "data provenance" for the foundational performance characteristics comes from the testing previously conducted for the predicate devices (MagPro Family device K094019 and Axon Therapy K210021), not a new test set for this 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 a 510(k) submission based on substantial equivalence, not a de novo clinical study with a new "test set" requiring expert ground truth establishment. The ground truth for safety and effectiveness is established by the prior clearance of the predicate device.

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

Not applicable. As above, there is no new clinical "test set" with adjudication.

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 Transcutaneous Electrical Nerve Stimulator for Pain Relief, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

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

Not applicable. This is a physical medical device (magnetic stimulator), not an algorithm or AI system. Its performance is intrinsic to the device's physical operation, not an algorithm's output.

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

The ground truth for the safety and effectiveness of the device's underlying technology and performance characteristics is established through:

• Prior FDA clearances: The substantial equivalence relies on the fact that the predicate devices (MagPro Family and Axon Therapy) were previously cleared by the FDA based on their demonstrated safety and effectiveness.
• Compliance with recognized standards: The document explicitly states compliance with standards like IEC60601-1 v3.1 (electrical, mechanical, chemical, thermal safety) and ISO 10993 (biocompatibility). These standards represent established "ground truths" for various aspects of device safety.
• Physiological understanding: The justification for wider pulse frequencies and repetition rates refers to the "range of physiological action potentials (from 0.05 to 500 Hz) of the human nervous system," indicating an appeal to established physiological knowledge as a "ground truth" for safety.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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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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.

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).

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