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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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The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).

The Apollo TMS Therapy System is comprised of the following principal components:

• User Interface
• Main Unit (with or without housing)
• Stimulation Coil
• Coil Positioning System

The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil which is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of a coil positioning system. The observed and documented increase in cortical excitability after high frequency (10Hz) rTMS has been shown to persist beyond the duration of the train of stimulation.

This document does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the Apollo TMS Therapy System, demonstrating its substantial equivalence to previously cleared predicate devices for the treatment of Major Depressive Disorder.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on:

• Intended Use and Device Description: The Apollo TMS Therapy System is an electromagnetic device for non-invasive stimulation of the cerebral cortex to treat Major Depressive Disorder.
• Compliance with Standards: Conforms to various ISO and IEC standards for medical devices, electrical safety, usability, software life cycle processes, and risk management.
• Non-Clinical and Clinical Performance Data: States that non-clinical testing was performed according to standards, and comparative testing for additional coils demonstrated substantial equivalence to predicate devices. It specifically mentions that clinical data on the treatment efficacy of the iTBS protocol was already demonstrated in a previous summary (K173620) and that verification testing confirmed constant intensity of individual stimuli.
• Software Verification and Validation: Conducted in accordance with IEC 62304, considered "basic documentation" as software failures are not likely to present high-risk situations.
• Risk Management: Applied throughout the product development life cycle, concluding no new hazards compared to predicate devices.
• Substantial Equivalence: The core of the submission, asserting that the Apollo TMS Therapy System is substantially equivalent to the HORIZON® TMS Therapy System (K182853) and an earlier version of the Apollo TMS Therapy System (K180313). This equivalence is based on identical intended use, indications for use, system components, operational procedures, and treatment protocols (especially iTBS).
• Comparative Table: Provides a detailed comparison of characteristics between the subject device and its predicates, highlighting similarities in indications for use, product code, classification, standard treatment stimulation parameters (e.g., area of brain stimulated, stimulation intensity, frequency, pulse train duration), output stimulation parameters, and coil parameters. It explicitly notes that the performance and clinical effectiveness are substantially equivalent.

In summary, this document is a regulatory submission demonstrating substantial equivalence rather than a clinical study report with specific acceptance criteria and performance data from a clinical trial.

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NeuroStar Advanced Therapy 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 NeuroStar Advanced Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).

NeuroStar Advanced Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar Advanced Therapy is used for patient treatment by prescription only under the supervision of a licensed physician and can be used in both inpatient and outpatient settings including physician's offices, clinics, and hospitals.

The proposed changes to the NeuroStar Advanced Therapy System described in this Traditional 510(k) Premarket Notification include the introduction of a new feature that allows the NeuroStar Advanced Therapy system to perform the TMS therapy known as intermittent theta burst stimulation (iTBS). NeuroBurst is the proprietary name for the iTBS treatment conducted by the NeuroStar Advanced Therapy System. The NeuroBurst treatment protocol consists of a burst of three (3) pulses at 50Hz with a 160ms interval between bursts. The protocol uses a train that consists of five (5) bursts per second for two (2) seconds with an eight (8) second interval between trains. A treatment session lasts for 20 trains or 3.3 minutes.

The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:

• Mobile Console for housing the electronics and includes a software controlled graphical user interface, display monitor, display arm, and gantry that supports the treatment coil.
• Ferromagnetic Coil for delivering treatment.
• Head Support System for positioning the treatment coil and includes a laser-guided alignment system.
• Multi-use consumable SenStar Treatment Link for contact sensing of the treatment coil with the patient's head and magnetic field quality control.
• TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software.

The provided text is a 510(k) summary for the NeuroStar Advanced Therapy System, primarily focusing on demonstrating substantial equivalence to a predicate device and introducing a new feature (iTBS treatment, or NeuroBurst). It lacks the specific details required to answer your questions about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.

The document describes a medical device (Transcranial Magnetic Stimulation System) for treating Major Depressive Disorder, not an AI/ML algorithm that predicts or diagnoses based on data. Therefore, the concepts of "test sets," "ground truth," "expert consensus," "MRMC studies," or "standalone algorithm performance" as typically applied to AI/ML device validation are not discussed.

The "performance data" mentioned here refers to:

• Physical performance of the device: magnetic field characteristics, output waveform, linear output level, electromagnetic compatibility (EMC), and electrical safety.
• Comparison to predicate/reference devices: demonstrating that the NeuroStar system's technological characteristics, indications for use, and principles of operation are substantially equivalent. The clinical effectiveness of iTBS itself is supported by the reference device's prior FDA clearance, not a new clinical study presented in this 510(k) summary for the NeuroStar device's NeuroBurst feature.

Therefore, I cannot extract the requested information as it is not present in the provided text.

To illustrate what kind of information would be needed to answer your questions, here's a hypothetical example relevant to an AI/ML device, assuming the NeuroStar was an AI/ML device (which it is not, based on this document):

Hypothetical Example (If NeuroStar were an AI/ML device):

Let's imagine the NeuroStar Advanced Therapy System had an AI component designed to predict patient response to TMS therapy based on patient characteristics and brain imaging data.

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

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

• Test Set Sample Size: 500 patients
• Data Provenance:
  • Country of Origin: Multi-center study including data from the United States (40%), United Kingdom (30%), and Canada (30%).
  • Retrospective/Prospective: Data collected prospectively from an observational cohort study specifically designed for AI model validation.

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

• Number of Experts: 3 independent expert psychiatrists.
• Qualifications of Experts: Each psychiatrist had at least 15 years of clinical experience in treating Major Depressive Disorder and specialized in TMS therapy. They were board-certified in psychiatry in their respective countries.

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

• Adjudication Method: 3-reader consensus. If all three experts agreed on the patient's responder status (responder or non-responder), that was taken as the ground truth. In cases of disagreement (e.g., 2 agree, 1 disagrees), a fourth, senior adjudicating psychiatrist (not involved in initial readings) reviewed the case and made the final determination.

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

• MRMC Study: Yes, an MRMC study was conducted.
• Effect Size:
  • Without AI Assistance: Average AUC for human readers was 0.70 (95% CI: 0.68-0.72).
  • With AI Assistance: Average AUC for human readers improved to 0.80 (95% CI: 0.78-0.82).
  • Improvement (Effect Size): The AI assistance led to an average increase of 0.10 in AUC for human readers (p

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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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