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NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).

The NeuroStar Advanced 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 induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components:

• Mobile Console
• System Software
• Treatment Chair
• Head Support System
• MT Cap
• . D-Tect MT Accessory
• TrakStar Data Management

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): 1,169 per protocol adolescent patients (age 12-21) were included in the real-world data analysis.
• Data Provenance: The data was retrospective real-world data (RWD) derived from the TrakStar registry, collected from patients across 347 TMS centers in the US over a span of 15 years, beginning in 2008.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their qualifications for the test set derived from the TrakStar registry. The clinical data was based on real-world data (RWD) which would imply physician diagnoses and assessments during routine clinical care, not necessarily a separate expert panel for ground truth within the study itself.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1 for the test set. The data was collected from clinical practice (TrakStar registry) and analyzed retrospectively.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned where human readers improved with AI vs. without AI assistance. The study focuses on the effectiveness of the NeuroStar Advanced Therapy System itself, not on an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

The NeuroStar Advanced Therapy System is a medical device that delivers transcranial magnetic stimulation, not a standalone algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI/ML devices, was not performed. The performance data relates to the device's clinical efficacy in treating MDD.

7. Type of Ground Truth Used

The ground truth for the real-world data analysis was based on clinical diagnosis of Major Depressive Disorder (MDD) according to DSM-4/ICD-9 or DSM-5/ICD-19 criteria, and Patient Health Questionnaire-9 (PHQ-9) scores for depression severity and remission, collected as part of routine clinical care and stored in the TrakStar registry.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm that requires training. The device itself is a non-AI medical device; however, the submission uses real-world clinical data and literature reviews to support its expanded indication. If "training set" refers to the data used to initially establish the device's efficacy, the previous FDA clearances (K083538, K130233, etc.) would have involved their own clinical studies. For this specific expanded indication, the submission relies on the large-scale retrospective analysis of 1,169 adolescent patients (treated with the NeuroStar device in real-world settings) and a literature review of 14 studies involving a total of 1,812 adolescents.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, this is not an AI/ML algorithm requiring a "training set" in the typical sense. The "ground truth" for the real-world data analysis and literature review, which serve as evidence for device efficacy, was established through:

• Clinical Diagnoses: Primary diagnosis of MDD according to DSM-4/ICD-9 or DSM-5/ICD-19 criteria.
• Validated Clinical Scales: Assessment using standardized and validated depression scales such as PHQ-9, HAMD-24, HAM-D, CDRS-R, QIDS-A17-SR, CGI-S, HDRS-17, BDI-II, MADRS, BPRS-C, and CGAS. These scores represent objective measures of symptom severity and improvement, as reported in clinical practice and research studies.
• Physician Assessment: The inclusion criteria for the RWD study specified "Primary diagnosis of Major Depressive Disorder (MDD), according to DSM-4/ICD-9 or DSM-5/ICD-19 criteria applicable on the date treatment with NeuroStar Advanced Therapy begins," indicating physician-based diagnosis.

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The NeuroStar Advanced Therapy System 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 failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

The NeuroStar Advanced 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 induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components:

• Mobile Console
• System Software
• Treatment Chair
• Head Support System
• TrakStar PC
• TrakStar Software

The NeuroStar Advanced Therapy System is indicated for treating depressive episodes and decreasing anxiety symptoms in adult patients with Major Depressive Disorder (MDD) who have not achieved satisfactory improvement from previous antidepressant medication.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes used for the test set and data provenance:
   The clinical performance data supporting the expanded indications primarily relies on two Randomized Controlled Trials (RCTs) and supportive real-world data (RWD) and observational studies.

   • RCTs (Test Set):

     • O'Reardon et al. (2007/2008): N=301 patients (Active: 155, Sham: 146). Data provenance is from a clinical trial that evaluated the safety and efficacy of the device for MDD.
     • George et al. (2010): N=190 patients (Active: 92, Sham: 98). Data provenance is from a company-independent, NIMH-funded trial.

   • Supportive Data (Test Set/Observational):

     • TrakStar (2022) study (unpublished): N=664 patients. This is a large-scale retrospective analysis of real-world data (RWD) derived from the TrakStar registry data, collected from patients across 75 TMS centers in the US over 13 years (since 2008). This is retrospective data.
     • Tuinstra et al. (2022): N=77 patients (57 with clinically significant anxiety symptoms). This is a retrospective analysis of medical records from patients with MDD and comorbid anxiety symptoms, over 3.5 years.

   The provenance is primarily retrospective clinical trial data (for the original MDD indication, now leveraged for anxiety) and retrospective real-world data/medical chart reviews for the updated anxiety indication. The country of origin for the studies is not explicitly stated for all, but given the US FDA submission and typical clinical trial conduct for device clearances, it's highly probable to be primarily US-based, especially for the TrakStar registry.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   The studies described are clinical trials and retrospective analyses of patient outcomes. "Ground truth" in this context refers to the documented clinical status of patients (e.g., diagnosis of MDD, anxiety symptoms, response to treatment, remission). While clinical diagnoses and symptom assessments would typically be performed by qualified clinicians (e.g., psychiatrists, physicians), the specific number of experts involved in establishing the initial diagnoses or ground truth for each patient in the test sets, or their specific years of experience, is not specified in the provided text. The studies utilized standardized psychiatric rating scales (HAMD-17, HAMD-24, HAMD – A/S F, PHQ-9, GAD-7), suggesting these were administered and interpreted by trained personnel.

4. Adjudication method for the test set:
   The provided text does not explicitly detail any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or evaluating patient outcomes in the test sets. The RCTs and observational studies would have relied on standard clinical assessment procedures and the reporting of scores from validated psychiatric rating scales.

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:
   No, an MRMC comparative effectiveness study was not done. The NeuroStar Advanced Therapy System is a Transcranial Magnetic Stimulation (TMS) device, which is a therapeutic device targeting brain regions for treatment, not an AI-assisted diagnostic tool that requires human readers to interpret images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   No, a standalone (algorithm only) performance study was not done. The device is a therapeutic system that is administered by clinicians to patients. Its performance is evaluated through clinical trials and real-world usage in human subjects, not as an isolated algorithm.

7. The type of ground truth used:
   The ground truth used for these studies is clinical outcomes data and expert-evaluated patient status according to standardized psychiatric rating scales.

   • Diagnosis of Major Depressive Disorder (MDD), confirmed by clinicians.
   • Level of depressive symptoms measured by scales like HAMD-17, HAMD-24, and PHQ-9.
   • Level of anxiety symptoms measured by scales like HAMD – A/S F and GAD-7.
   • Response to treatment (e.g., ≥50% reduction in symptom scores, or ≥6 point reduction for GAD-7/PHQ-9).
   • Remission (e.g., GAD-7 < 5, PHQ-9 < 5, HAMD AS/F < 7).

8. The sample size for the training set:
   The provided information describes clinical studies primarily for validation or performance demonstration of the device for specific indications. It does not mention a "training set" in the context of machine learning model development. The NeuroStar Advanced Therapy System is a physical medical device, not an AI/ML algorithm whose parameters are iteratively "trained" on data. The clinical data presented is for demonstrating safety and effectiveness.

9. How the ground truth for the training set was established:
   As no explicit "training set" in the AI/ML sense is mentioned for this device, this question is not directly applicable. If interpreting "training set" loosely as the cumulative clinical experience and data that informed the device's development or initial indications, the "ground truth" would have been established through a combination of medical understanding of MDD, clinical research, previous clinical trials, and regulatory requirements for therapeutic interventions.

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

The 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 Maqnetic 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. NeuroStar Advanced Therapy uses a well-understood property of physics regarding the law of electromagnetic induction, which states that a time-varying or moving magnetic field will induce an electric current in an adjacent conductive substance with the electric current traveling in a direction perpendicular to the motion of the magnetic field. NeuroStar Advanced Therapy uses a generated magnetic field as a vector for delivering an electrical current to a tarqet conductor of interest, which in therapeutic application, is the brain. By using this method of delivering electrical current to the brain the electrical current produced in the brain can be delivered in an anatomically focused manner at discrete cortical areas of interest and can avoid areas of the brain that are not relevant for its therapeutic actions.

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
• . Optional MT Cap for
• Multi-use consumable SenStar Treatment Link for contact sensing of the ● treatment coil with the patient's head and maqnetic field quality control.
• TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software

Here's a breakdown of the acceptance criteria and study information for the NeuroStar Advanced Therapy System, based on the provided FDA 510(k) summary:

The primary purpose of this 510(k) submission is for the addition of the MT Cap accessory. The document explicitly states that the NeuroStar Advanced Therapy System (the subject device) has the same indications for use and technological characteristics as the predicate device, implying that the core system's performance metrics have already been established in previous submissions. This K213543 submission focuses on the safety and effectiveness of the new accessory.

Therefore, the "acceptance criteria" and "device performance" in the context of this specific submission revolve around demonstrating that the MT Cap accessory does not negatively impact the existing performance or introduce new risks, and that it functions as intended to aid in the Motor Threshold Hunt process.

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is an update for an accessory (MT Cap) to an already cleared device, the acceptance criteria are focused on demonstrating that the accessory does not compromise the device's safety or efficacy. The document does not provide specific quantitative performance metrics tied to sensitivity, specificity, accuracy, or similar measures typically found in standalone diagnostic AI/ML device acceptances. Instead, the "performance" demonstrated is compliance with relevant standards and successful usability.

Study Information Specific to the MT Cap Accessory

1. Sample Size used for the test set and the data provenance:

   • The document states, "There is no clinical testing required to support this submission."
   • For Usability testing, the sample size is not explicitly stated in the provided text. Usability studies typically involve a small number of representative users (e.g., 8-15) as per human factors guidance, but the exact number is not here.
   • The provenance for usability testing would typically be prospective, involving healthcare professionals interacting with the device/accessory. The document does not specify country of origin for usability test participants.

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

   • As no clinical testing was required, there was no "ground truth" to establish in the traditional sense of disease diagnosis or outcome for the MT Cap.
   • For usability testing, "experts" would be the healthcare professionals participating in the test. Their qualifications would typically involve experience with TMS procedures. The document does not specify the number or detailed qualifications of these individuals.

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

   • Not applicable as there was no clinical study with a diagnostic endpoint requiring adjudication. Usability studies use qualitative and quantitative measures of user performance, error rates, and satisfaction rather than adjudication of findings.

4. 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:

   • No MRMC or comparative effectiveness study was done. This device is a hardware accessory (MT Cap) for a TMS system, not an AI/ML diagnostic or assistive algorithm. The MT Cap is a physical guide to assist in a manual process (Motor Threshold Hunt), not an AI.

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

   • Not applicable. The MT Cap is a passive physical accessory, not an algorithm.

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

   • Not applicable for the MT Cap accessory. For the overall NeuroStar system (established in prior submissions), ground truth for Major Depressive Disorder (MDD) efficacy would have been based on clinical assessments (e.g., Hamilton Depression Rating Scale, Montgomery-Åsberg Depression Rating Scale) and clinical outcomes, but this is not part of this submission.

7. The sample size for the training set:

   • Not applicable as this is not an AI/ML device requiring a training set.

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

   • Not applicable as this is not an AI/ML device requiring a training set.

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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.

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 in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode. 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 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 acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below. It is important to note that this document primarily focuses on non-clinical testing for substantial equivalence to predicate devices, rather than a clinical effectiveness study against a gold standard.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical testing conducted to validate the performance of the Horizon® 3.0 TMS Therapy System and to ensure it meets design specifications and relevant FDA guidance. The "acceptance criteria" here are generally compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" is the outcome of these compliance tests.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical bench testing and verification/validation activities on the device itself.

• For tests like Electrical Safety, EMC, and Alarm Systems, a "sample Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+)" was used.
• For Biocompatibility, "samples of these materials" (patient-contacting components) were tested.
• For Human Factors, "Usability testing was performed to Horizon® 3.0 TMS Therapy System."

Data Provenance: This is not applicable to the non-clinical testing described, as it does not involve patient data. The tests were performed by independent test laboratories (BSI Appliances, Eurofins Hursley) and internally by Magstim.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable as the study involves non-clinical engineering and systems testing, not the establishment of a medical 'ground truth' based on expert consensus for diagnostic or prognostic purposes. Compliance with standards and direct measurement against specifications serve as the "ground truth."

4. Adjudication Method for the Test Set

This is not applicable, as the study does not involve expert adjudication of medical cases. The tests are objective measurements and compliance checks performed by qualified testing laboratories and the manufacturer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states that the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical trial of effectiveness. There is no mention of human readers or AI assistance in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physical medical system (Transcranial Magnetic Stimulation Therapy System), not primarily an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the typical sense of AI diagnostics. However, the software components of the device were a subject of extensive verification and validation testing, including assessing cybersecurity risks, as part of the overall system. This can be seen as an evaluation of the system's inherent performance, albeit for a complex electro-mechanical system rather than a purely diagnostic algorithm.

7. The Type of Ground Truth Used

For this submission, the "ground truth" for the non-clinical testing is:

• Recognized International and National Standards: e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 10993 series, AAMI/ANSI HE75, IEC 62366-1.
• Design Specifications and Intended Performance: The device was tested to ensure it performs as intended and meets its internal design specifications.
• FDA Guidance: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."
• Predicate Device Characteristics: Comparison of the new device's technical specifications and performance to legally marketed predicate devices to establish substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. The document describes a 510(k) submission based on non-clinical testing for substantial equivalence. It does not involve machine learning models that require training sets of data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as no machine learning training set is described in the document.

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