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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 Horizon® 3.0 TMS Therapy System is intended to produce and deliver 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.

Horizon® 3.0 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Horizon® 3.0 TMS 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").

The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.

Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.

The provided text describes a 510(k) premarket notification for the Magstim Horizon 3.0 TMS Therapy System, seeking substantial equivalence to existing devices for the treatment of Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD).

However, the document does not contain the results of a study designed to directly prove the device meets specific acceptance criteria based on clinical performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and limited non-clinical testing.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available from the provided text in the way they would be for an AI/ML diagnostic or prognostic device.

Here's an analysis based on the available information:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The device, Magstim Horizon 3.0 TMS Therapy System, is a medical device for therapeutic intervention (Transcranial Magnetic Stimulation), not a diagnostic or prognostic device that typically has performance metrics like sensitivity or specificity. The "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices, focusing on safety and effectiveness.

The "study" referenced for performance is primarily non-clinical testing and reliance on prior FDA clearances and published literature for predicate devices to support the extension of indications for use.

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

Since the device is a therapeutic system and not a diagnostic one, the acceptance criteria are not in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are centered on demonstrating that the proposed changes (primarily for OCD treatment indication) do not raise new questions of safety or effectiveness compared to predicate devices, and that the device can reliably deliver the therapy.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Software Verification & Validation: The sample size for testing specific software functions or modules is not explicitly stated, but it would involve testing different use cases and parameter configurations. The data provenance is internal to the manufacturer's testing processes.
• Performance Verification of Therapeutic Delivery: Not specified as a typical patient "test set." Verification involves testing the device under various operational conditions.
• FEM Modeling: This is a computational simulation, not a physical test set with human subjects.
• Human Factors Testing: The sample size of "representative TMS users" is not explicitly stated. The provenance is likely internal testing data.
• Clinical Efficacy (Retrospective Study): The retrospective open-label study referenced (Oliveira-Maia, Garcia-Guarniz, et al.) is external scientific literature, not a study specifically conducted for this 510(k). The sample size for this study is not provided in the snippet, nor is the country of origin. It is a retrospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable in the context of this 510(k) submission, as it focuses on device safety and functional equivalence for a therapeutic system, not on establishing ground truth for diagnostic classifications by expert consensus. The "ground truth" for the device's function is its ability to reliably and safely deliver magnetic stimulation as intended, which is verified through engineering tests and adherence to standards.

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

Not applicable. This concept is typically used in studies where human readers independently evaluate data and their findings require reconciliation to establish a ground truth. The non-clinical tests and simulations for the TMS system don't involve this type of 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 therapeutic system, not a diagnostic or AI-assisted interpretation tool where "human readers" would be involved in interpreting cases with or without AI assistance. The retrospective clinical study referenced in the submission is a comparative efficacy study of two different TMS devices, not an MRMC study involving AI assistance for human readers.

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

This concept is not directly applicable. The device itself is a clinical tool used by a human operator (licensed physician). There is no "algorithm only" performance for a therapeutic TMS system. The software and hardware perform specific functions, but the overall therapy involves human-in-the-loop operation.

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

For the non-clinical tests:

• Software V&V: Ground truth is defined by specified software requirements and expected outputs.
• Performance Verification: Ground truth is defined by recognized safety limits and therapeutic delivery specifications (e.g., maximum output, temperature limits) as per international standards.
• FEM Modeling: Ground truth is derived from the physics principles governing electromagnetic fields and computational models, validated against known physical laws and prior successful device models.
• Human Factors: Ground truth relates to user comprehension, ability to perform tasks, and low variability in coil positioning, assessed against defined human factors engineering principles and successful task completion.

For the claim of substantial equivalence for clinical efficacy:

• Prior Equivalency Determination (K143531): FDA's prior determination of substantial equivalence for MDD treatment implies an acceptance of equivalent clinical outcomes based on comparative data.
• Retrospective Open-Label Study: The ground truth for this study would be patient outcomes (e.g., reduction in depression symptoms) as measured by clinical scales, which is a form of outcomes data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a "training phase" on a dataset in the conventional sense. The development of the device follows engineering design, verification, and validation principles.

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

Not applicable, as there is no "training set" in the context of this medical device's development or regulatory submission.

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