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MagVenture TMS Therapy is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The MagVenture TMS Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The MagVenture TMS Therapy System is a transcranial magnetic stimulation device. Specifically, it 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.

Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp.

The pulses generate an electric field in the underlying brain tissue. When this field surpasses a specific threshold and aligns appropriately with the brain's neuronal pathways, it induces localized axonal depolarization, leading to neuron activation in the targeted brain region.

The MagVenture TMS Therapy System represents an integrated system comprised of the following components:

• Magnetic Stimulator (MagPro Family)
• Coil for motor threshold determination: C-B60, C-B70
• Treatment Coils: Cool-B65, Cool-B70, Cool D-B80
• Accessories:
  • Trolley with mounting for super flexible arm and coil holder arrangement)
  • Patient head fixation
  • Super flexible arm or Flow Arm for coil fixation
  • Isolation transformer
  • Cooler Unit
  • Caps and Marking accessory (marking plate, pen, ruler) – Beam F3 or 5.5 cm Coil Placement
  • Vacuum pump and Vacuum pillow with Pillow Case for patient head fixation (Optional)
  • Treatment Chair (Optional)
  • Coil Hub (Optional)
  • MagVenture TMS Atlas Neuro Navigation System (Optional)

Except for the Beam F3 marking plate, all components have previously received FDA clearance. The MagVenture TMS Therapy System and its technological characteristics remain equivalent to those cleared under K150641, K171481, K171967, K173620, K193006 for Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD) indications.

This submission introduces the following modifications:

• Expanded Indications: Includes treatment for depressive episodes and comorbid anxiety symptoms in adult patients with MDD who have not responded satisfactorily to prior antidepressant medication.
• Coil Approval Expansion: All three MagVenture treatment coils are now included for MDD, MDD w/ comorbid anxiety symptoms, depressive episodes, and OCD treatment.
• Beam F3 Marking Method: Introduces the Beam F3 marking plate as an alternative to the standard 5.5 cm method for coil positioning in the dorsolateral prefrontal cortex (DLPFC).

All other aspects of the device compared to the currently marketed MagVenture TMS Therapy remain unchanged.

The provided FDA 510(k) clearance letter for the MagVenture TMS Therapy System does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially in the context of AI/algorithm performance.

This document is a traditional 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria for a new, AI-driven diagnostic or therapeutic system.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Device Type: The MagVenture TMS Therapy System is a Transcranial Magnetic Stimulation device, an electromechanical medical device that physically delivers magnetic pulses. It is not an AI-driven diagnostic or therapeutic algorithm. The "AI" context in your prompt is not relevant to this specific device.
• Focus of 510(k): The core of this 510(k) summary is to demonstrate that the MagVenture TMS Therapy System, with its introduced modifications, is "substantially equivalent" to an existing predicate device (NeuroStar Advanced Therapy System, K230029). This is shown by comparing technological characteristics, indications for use, and treatment parameters, not by conducting novel clinical trials to establish its own efficacy against predefined acceptance criteria for AI performance.
• "Performance Data" Section (Page 16): This section explicitly states:
  • "No clinical performance data were included in this submission."
  • Performance testing summarized relates to electrical safety, electromagnetic compatibility (compliance with IEC standards), and quality/risk management (ISO standards).
  • Computational modeling (SimNIBS v4.0.1) was used to compare electric field strength of coils, which is a physical characteristic, not a clinical efficacy or AI performance metric.

Therefore, I cannot provide the requested information based on the provided document. The document discusses the device's technical specifications and its equivalence to a predicate device, but not how it meets acceptance criteria for an AI or imaging-based clinical outcome.

Specifically, the following points from your request cannot be addressed as they pertain to AI/algorithm performance studies which are not described in this 510(k):

1. Table of acceptance criteria and reported device performance (for AI performance): Not applicable. The "performance" discussed is electrical and safety compliance, not AI accuracy or efficacy.
2. Sample size for test set and data provenance: No clinical test set data for algorithm performance is mentioned.
3. Number of experts and qualifications for ground truth: No expert-driven ground truth establishment for AI is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as there's no AI component or human-in-the-loop study discussed.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of AI/algorithm performance.
8. Sample size for training set: No training set for an algorithm is mentioned.
9. How ground truth for training set was established: Not applicable.

This 510(k) clearance is for a physical medical device, not an AI software.

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Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The MagVenture Coil T65 is a figure-of-eight, actively cooled coil designed for use in transcranial magnetic stimulation (TMS) therapy as part of the MagVenture TMS Therapy System. The system delivers magnetic pulses for generating evoked responses, assessing motor thresholds (MT), and administering therapeutic treatments.

The T65 is a redesign of the treatment coil Cool-B65, to include the motor threshold (MT) determination capability of the C-B60 coil. This reduces the need for coil exchange during patient sessions, supporting a more streamlined workflow for clinicians.

The T65 incorporates several ergonomic and functional enhancements compared to the existing coil:

• Integrated intensity control wheel allowing direct manual adjustment of stimulation output.
• Built-in trigger button with LED status indication to display coil readiness.
• Reduced weight for improved maneuverability and ease of use.
• Strain relief mechanisms at both the coil and connector ends to improve durability and reduce cable stress.

The provided FDA 510(k) clearance letter for the T65 Repetitive Transcranial Magnetic Stimulation System does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

This document is a Special 510(k) submission, which signifies that the device (T65 coil) is a modification of an existing cleared device (Cool-B65 coil) and that the modifications do not raise new questions of safety or effectiveness. The core of such a submission is to demonstrate substantial equivalence to a predicate device.

Specifically, the document states:

• "No clinical testing is required to support this submission." This explicitly indicates that no comparative effectiveness study (like an MRMC study) or standalone performance study was performed or needed.
• The comparison focuses on technological characteristics (weight, integrated intensity control, trigger button, materials, electrical safety, etc.) and states that these differences "does not raise different questions of safety and effectiveness compared to the existing device."
• The non-clinical testing focuses on compliance with general safety and performance standards (IEC 60601-1, IEC 60601-1-2, ISO 13485, ISO 14971) and ensuring magnetic field characteristics are within a ±5% tolerance of the predicate device. This is a performance verification of the physical device components, not an AI or algorithm performance evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert involvement, or AI performance metrics because this information is not present in the provided text. The device is a physical medical device (a TMS coil), not an AI-powered diagnostic or therapeutic algorithm.

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The MagVenture TMS Therapy System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The MagVenture TMS Therapy system - for adjunctive treatment of OCD 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 MagVenture TMS Therapy system - for treatment of OCD is indicated as an adjunct for the treatment of adult patients who are suffering from Obsessive-Compulsive Disorder (OCD). MagVenture TMS Therapy system has previously obtained FDA clearance for treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (K150641, K171481, K172667 and K173620).

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 cleared TMS protocol for treatment of OCD uses repetitive transcranial magnetic pulses applied at a frequency of 20 Hz. The safety and effectiveness for treatment of OCD have been established in a clinical trial that lead to an FDA De Novo clearance of the primary predicate device, the Brainsway DTMS system. The present 510(k) does not include new pivotal data, but includes clinical trial data on more than 500 subjects treated with the Mag Venture TMS Therapy System, in order to demonstrate performance and safety. Treatment of OCD is applied to the human brain of the bilateral dorsomedial prefrontal cortex (DMPFC) using 20 Hz TMS for 18 min. The treatment parameters are identical to those recommended by the Primary Predicate Device.

The MagVenture TMS Therapy system – for adjunctive treatment of OCD is an integrated system consisting of the following components:

• MagPro Stimulator and Trolley .
• MagPro Family (R30, R30 w. MagOption, X100, X100 w. MagOption) o
• Trolley with holding arrangements o
• Coil for MT determination and OCD treatment .
• Coil Cool D-B80 with Coil Cooler Unit o
• Marking apparatus for locating treatment area .
• 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 is a 510(k) summary for the MagVenture TMS Therapy System for adjunctive treatment of OCD. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

No specific acceptance criteria table for effectiveness is provided in the document. The document establishes substantial equivalence based on prior clearances, identical intended use and treatment parameters with a primary predicate device, and non-clinical and clinical data supporting safety and performance.

The acceptance of this device seems to be primarily based on demonstrating a substantial equivalence to an already cleared predicate device (Brainsway Deep Transcranial Magnetic Stimulation (DTMS) system, HAC – H7 coil (DEN170078, K183303)) in terms of safety and performance for the adjunctive treatment of OCD.

The document states: "The new device is substantially equivalent to the primary predicate device in terms of performance, effectiveness and safety."

Here's a breakdown of the requested information based on the provided text:

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

As mentioned, no explicit table of acceptance criteria for effectiveness is present. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the primary predicate device, particularly regarding its ability to treat OCD. The reported device performance is discussed in terms of its similarity to the predicate and general safety/tolerability demonstrated in other studies.

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

• Test Set for Effectiveness (Implicitly for OCD): The primary predicate device's pivotal trial (Carmi et al. (2)) included a total of n=99 subjects, of which n=50 received active TMS treatment for OCD. The provenance of this data is a "Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial." (Page 12, reference 2). This study's country of origin is not explicitly stated in this document but is typically associated with the predicate manufacturer (Brainsway Ltd., Israel).
• Test Set for Safety and Performance of the New Device: "clinical trial data on more than 500 subjects treated with the MagVenture TMS Therapy System" (Cool D-B80 coil). This data focuses on safety and general performance (e.g., determining Motor Threshold). "Most of the clinical research performed using the new device has been conducted outside the USA." (Page 7). Most research focused on treatment-resistant depression (TRD) or major depressive disorder (MDD), but the document argues for relevance to OCD due to shared underlying deficits and similar treatment targeting. A "small pilot trial using the new device also demonstrated a clinically and statistically significant effect of treatment of OCD," but the number of subjects for this specific OCD trial is described as "low number of subjects" and not specified further.

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

The document does not provide details on the number or qualifications of experts for establishing ground truth specifically for the effectiveness test set. The effectiveness relies on the previously published pivotal trial for the primary predicate device (Carmi et al.), which would have utilized clinical diagnoses and outcome measures as ground truth. For the predicate study, the "ground truth" for OCD diagnosis would have likely been established by qualified psychiatrists or clinicians using standardized diagnostic criteria (e.g., DSM-V).

4. Adjudication method for the test set

The document states that the primary predicate device's pivotal trial was a "Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial." (Page 12, reference 2). This implies a rigorous study design where treatment assignments and outcome assessments would have been blinded, contributing to the establishment of reliable "ground truth" regarding treatment efficacy. However, a specific "adjudication method" beyond standard blinded clinical trials is not explicitly detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This device is not an AI/CAD system evaluated by human readers interpreting images. It is a medical device for direct therapeutic intervention. The "effectiveness" is assessed by measuring clinical outcomes in patients.

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

This question is not applicable as the device is a TMS therapy system, not an algorithm or AI. It is a physical device that delivers magnetic stimulation to the brain for therapeutic purposes. Human operators are involved in setting up and operating the device for patient treatment.

7. The type of ground truth used

• For effectiveness (via predicate study): Clinical diagnosis of Obsessive-Compulsive Disorder (OCD) and clinical outcome measures (e.g., symptom severity scales like Y-BOCS - Yale-Brown Obsessive Compulsive Scale, though not explicitly mentioned here, this is standard for OCD trials) in a controlled clinical trial setting.
• For safety/performance of the new device: Clinical observation of adverse events, tolerability, and physiological measurements (e.g., Motor Threshold determination).

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning or AI. The device is a physical medical device. The closest analogy might be the clinical data supporting the device's original clearances for MDD, which forms the basis of its design and operational parameters. The document mentions "clinical trial data on more than 500 subjects treated with the MagVenture TMS Therapy System," mostly for MDD, which informed safety and general operational performance, effectively acting as "training" for understanding the device's characteristics in a clinical setting.

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

Again, this is not a machine learning context. For the clinical data on >500 subjects (mostly MDD), the "ground truth" for the disease state would have been clinical diagnoses of MDD or TRD by qualified medical professionals using standard diagnostic criteria. For safety aspects, reported adverse events and clinical assessments would have constituted the "ground truth."

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