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MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15-21).

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, K170114, K171481, K171967, K172667, K173620.

This submission introduces the following modifications:

• Expanded Indications: MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21)
• Coil Approval Expansion: Inclusion of Cool D-B80 for MDD in adolescent patients (age 15-21).
• 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).

Apart from the modifications outlined above, the core design, fundamental operating principles, and safety characteristics remain substantially equivalent to the previously cleared MagVenture TMS Therapy System.

The provided FDA 510(k) clearance letter and associated summary pertain to the MagVenture TMS Therapy System. However, this documentation does not describe an acceptance criteria table or a study that specifically proves the device meets such criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for the treatment of Major Depressive Disorder (MDD) in adolescent patients, expanding indications, and introducing a new coil positioning method. It highlights non-clinical performance testing against electrical safety and performance standards (e.g., IEC 60601-1) and a clinical literature review to support safety and effectiveness.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML enabled medical device, as the provided text relates to a Transcranial Magnetic Stimulation (TMS) system, which is a hardware-based therapy device, not an AI/ML diagnostic or prognostic tool.

The questions you've asked are highly relevant for the clearance of AI/ML medical devices (e.g., in medical imaging or diagnostics), which require rigorous validation of their algorithmic performance. The provided document does not contain this information because the MagVenture TMS Therapy System is not an AI/ML enabled device.

To answer your request accurately, based on the provided text, I can only state that the document does not contain the information required to populate the fields related to AI/ML device acceptance criteria and validation studies.

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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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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 MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.

The MagVenture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.

The provided text describes the acceptance criteria and supporting studies for the MagVenture TMS Atlas Neuro Navigation System.

1. Table of Acceptance Criteria and Reported Device Performance

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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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The MagVita TMS Therapy System w/ Theta Burst Stimulation 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 w/Theta Burst Stimulation 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 MagVita TMS Therapy System w/ Theta Burst Stimulation is indicated for the treatment of Major Depressive Disorder (MDD) 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. The standard-of-care FDA approved TMS protocol for treatment of MDD uses repetitive transcranial magnetic pulses applied at a frequency of 10 Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10 Hz rTMS) repetitive TMS (rTMS) has been shown to persist beyond the duration of the train of stimulation, and 10 Hz rTMS on the Left-Dorsolateral prefrontal cortex (L-DLPFC) has been shown to be effective and safe in the treatment of MDD. A newer form of the TMS, called intermittent Theta Burst Stimulation (iTBS), mimics the endogenous theta rhythms of the human brain, and has been shown to evoke equally potent excitatory effects. Intermittent TBS provides bursts of three individual stimuli at a rate of 50 Hz (i.e. 20 ms apart), repeated at 5 Hz (i.e. 200 ms between burst) mimicking the theta rhythm of the brain. Thus, the iTBS protocol is more demanding in terms of stimulator output. The clinical performance is based on the fact that the actual individual stimuli are of equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.

MagVita TMS therapy system w/Theta Burst stimulation is applied to the human brain of the left dorsolateral prefrontal cortex (L-DLPFC) using iTBS.

The MagVita TMS Therapy System w/ Theta Burst Stimulation is an integrated system consisting of the following components:

• MagPro Stimulator and Trolley .
  • o MagPro family
  • Trolley with holding arrangements o
• Coil for MT determination and Depression treatment .
  • o Coil Cool-B70 with Coil Cooler Unit
• Marking apparatus for locating treatment area .
  • Marking plate for Coil Cool-B70 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 .

The provided text describes a 510(k) premarket notification for the MagVita TMS Therapy System with Theta Burst Stimulation. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study designed to prove the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and ground truth establishment cannot be found or directly inferred from the provided document as it is a regulatory submission for product clearance based on substantial equivalence, not a clinical trial report with a defined performance study against specific acceptance criteria.

However, I can extract and infer some information, particularly regarding the clinical evidence used to support the substantial equivalence claim.

Here's an attempt to answer the questions based on the provided text, highlighting what is present and what is missing:

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

The document does not present specific quantitative acceptance criteria or reported device performance metrics in a table form as would be expected from a device validation study. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices, focusing on similar indications, technological characteristics, safety, and effectiveness.

The closest to "acceptance criteria" are the performance standards the device complies with, which are qualitative:

• ISO 13485:2012
• IEC60601-1
• IEC60601-1-2

The reported device performance is described qualitatively and comparatively:

• "The MagVita TMS Therapy System w/Theta Burst Stimulation, is as safe and effective and performs as well as the predicate devices with enhanced ease of use and reduced treatment time to the benefit of both patient and operator."
• "The clinical performance and effectiveness, as well as tolerability and side effect profile for the new device and the predicate devices are substantially equivalent."
• "the MagVita TMS Therapy System w/Theta Burst Stimulation delivers stimuli of equal intensity, thereby verifying that the dose is maintained throughout the course of treatment." (Non-clinical performance)
• Compliance with permissible sound pressure levels and OSHA exposure thresholds. (Non-clinical performance)
• Magnetic field distribution is "substantially equivalent" to predicate devices. (Non-clinical performance)

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

The document does not describe a "test set" in the context of a dedicated prospective validation study for the new device.

It refers to a "large randomized, multicenter trial" that "demonstrated the effectiveness, safety and tolerability of iTBS." This trial likely involved a sample size of patients, but the specific number is not provided.

The data provenance for this trial is not stated (e.g., country of origin, retrospective/prospective). However, given it's a "randomized, multicenter trial," it implies a prospective design.

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

This information is not provided. The document relies on the findings of a pre-existing "large randomized, multicenter trial" that established the clinical effectiveness of iTBS generally, and then argues that the MagVita system implementing iTBS is substantially equivalent to existing 10 Hz rTMS systems. Clinical outcomes from the trial (e.g., improvement in MDD symptoms) would serve as the ground truth, but how they were established or by whom (e.g., expert raters) is not detailed.

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

This information is not provided.

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

An MRMC study is relevant for imaging devices or AI tools where human readers interpret data. This device is a Transcranial Magnetic Stimulation system for therapeutic treatment, not an AI or imaging diagnostic device. Therefore, an MRMC study is not applicable and was not performed. The "comparative effectiveness" mentioned refers to the effectiveness of iTBS compared to 10 Hz rTMS, not human performance with/without AI assistance.

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

This refers to a device that is autonomous (e.g., an AI algorithm). This device is a therapeutic system that requires operator setup and patient interaction. Therefore, a "standalone algorithm-only" performance study is not applicable.

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

For the safety and effectiveness of iTBS in general, the "ground truth" was likely based on patient outcomes data from the "large randomized, multicenter trial," specifically regarding the "treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode." This would involve clinical assessments of symptom improvement.

For the substantial equivalence claim, the ground truth for specific performance parameters of the MagVita system (e.g., magnetic field distribution, stimulus intensity, sound levels) was established through non-clinical performance testing against physical specifications and standards, as described in the document.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning. The "large randomized, multicenter trial" referenced for clinical performance represents the evidence base for iTBS, not a training set for the MagVita device itself.

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

As there is no "training set" described in the machine learning sense, this question is not applicable. The clinical effectiveness of iTBS was established through a "large randomized, multicenter trial," which would have had its own methods for establishing the ground truth of patient outcomes (e.g., validated depression scales, clinical interviews). These methods are not detailed in this document.

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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 Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Mag Vita 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 MagVita 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 MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC). The MagVita TMS Therapy System consists of the following components: MagPro Stimulator , Trolley and Super Flexible Arm . Coil for MT determination . Marking apparatus for locating treatment area . Coil for Depression Treatment . Isolation Transformer

This document, K171967, is a 510(k) summary for a modification to the MagVita TMS Therapy System, not a study presenting new clinical efficacy data for the device itself.
Therefore, the document does not present acceptance criteria or a study proving the device meets those criteria in the way a clinical trial would for a new device's efficacy.

Instead, this submission is to demonstrate substantial equivalence of a modified device (one without a proprietary treatment chair and head support) to a previously cleared device. The "acceptance criteria" here are essentially the demonstration that the modified device's performance characteristics are largely unchanged and that it adheres to relevant safety standards.

Here's how to interpret the provided information in the context of your request:

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

The document provides a comparison table (pages 5 & 6) between the modified MagVita TMS Therapy System and its predicate device (MagVita TMS Therapy System K150641/171481), as well as other predicate devices regarding the treatment chair. The "acceptance criteria" are implied to be the characteristics of the predicate device, and the "reported device performance" is how the modified device compares.

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

This document does not describe a clinical study with a test set of patient data. It describes a technical and regulatory comparison for a device modification. The "data" here refers to the device's technical specifications and compliance with standards.

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 assessing clinical performance based on expert review of medical data. The ground truth for the device's technical specifications and safety compliance is established through engineering design, testing, and adherence to recognized standards.

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

Not applicable, as there is no test set in the sense of patient data requiring 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 Transcranial Magnetic Stimulator (TMS), not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

Not applicable. The MagVita TMS Therapy System is a physical medical device for treatment, not a standalone algorithm.

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

The "ground truth" for this 510(k) submission is the technical specifications, performance characteristics, and safety standards of the predicate device (MagVita TMS Therapy System K150641/171481) and recognized international standards (ISO, IEC). The aim is to demonstrate that the modified device is substantially equivalent to this established ground truth.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning algorithm requiring a training set.

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

Not applicable. There is no training set mentioned in this document.

In summary: The K171967 document is a premarket notification for a modification to an existing device. It demonstrates substantial equivalence by comparing the modified device's technical specifications and adherence to safety standards against its predicate, rather than presenting a clinical study with patient data and performance metrics like sensitivity/specificity.

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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 recieve 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 MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).

The provided document is a 510(k) summary for the MagVita TMS Therapy System (K171481). This document asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study designed for that purpose. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in terms of clinical efficacy against numerical thresholds, is not present in this document.

The document focuses on demonstrating that the modified MagVita TMS Therapy System (K171481) is as safe and effective as previously cleared predicate devices (MagVita TMS Therapy System, K150641, and Neurostar TMS Therapy System, K160703). The primary modification is a reduction in inter-train interval, leading to shorter treatment times.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what is missing:

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

The document does not provide a formal table of explicit acceptance criteria with numerical thresholds for clinical performance (e.g., specific rates of symptom reduction or remission). Instead, it states that the device is "safe and effective," and that "all other identified differences between the three systems are minor and without impact on safety or efficacy."

The table provided in the document compares various technical specifications and operational parameters of the subject device to its predicates. These comparisons serve as the "performance" data to argue for substantial equivalence, rather than direct measurements against pre-defined clinical acceptance criteria.

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

This information is not provided as the submission is a 510(k) for substantial equivalence, not a clinical trial report with a test set of patient data for efficacy evaluation. The "test set" in this context refers to the device's adherence to the technical specifications of its predicates. Non-clinical performance data for components was "tested as required" and cleared in previous 510(k) submissions (K091940 and K150641), but no details on sample sizes or data provenance are given for these tests.

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 information is not applicable/not provided. The "ground truth" in this submission relates to the technical specifications and operational parameters, which are established through engineering design, testing, and regulatory standards, not expert clinical consensus on patient data.

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

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies when establishing ground truth from multiple expert interpretations of medical data. This document focuses on technical equivalence.

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

This information is not applicable/not provided. An MRMC study is relevant for diagnostic devices often involving human interpretation of images or other data with and without AI assistance. This device is a therapeutic system (rTMS) for Major Depressive Disorder, not a diagnostic imaging device. It does not involve "human readers" in the sense of interpreting outputs that an AI could also interpret.

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

This information is not applicable/not provided. This device is a physical therapeutic system and does not function as an "algorithm only" device without human involvement. It requires a trained clinician for setup, motor threshold determination, coil positioning, and ongoing patient monitoring.

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

The "ground truth" in this context is based on:

• Compliance with established medical device standards (e.g., ISO 13485:2012, IEC60601-1, IEC60601-1-1, IEC60601-1-2).
• Demonstration of technical and operational equivalence to predicate devices cleared by the FDA, which were previously determined to be safe and effective based on their own clinical evidence (or substantial equivalence to even earlier devices).
• The premise that minor modifications (like adjusted inter-train interval for shorter treatment time) do not introduce new safety concerns or alter efficacy, meaning the "ground truth" of safety and efficacy established for the predicates applies.

8. The sample size for the training set

This information is not applicable/not provided. No "training set" of patient data is mentioned or implied, as this is a traditional medical device submission for a physical therapy system, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable/not provided for the same reasons as point 8.

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