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510(k) Data Aggregation

    K Number
    K231926
    Device Name
    NeuroStar Advanced Therapy System (All previously cleared models)
    Manufacturer
    Neuronetics, Inc.
    Date Cleared
    2024-03-22

    (266 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K083538,K130233,K133408,K160703,K161519,K201158,K213543,K222230,K230029
    Predicate For
    K243869,K251125,K243700
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    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
    AI/ML Overview

    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

    Acceptance Criteria (Success Criteria)Reported Device Performance
    A minimum of 50% of the primary per protocol analysis population meet the Individual Subject Success Criteria (defined as a meaningful reduction in depression symptoms based on PHQ-9 scores over a pre-post TMS treatment interval of 6 weeks and achieving remission of MDD symptoms).77.8% (95% CI: 72.8%, 83.0%) of the primary per protocol population met the criteria.
    The lower limit of the 95% confidence interval for individual success rate should exceed the pre-established Overall Study Success Criteria of a minimum 50%.The lower limit (72.8%) exceeded 50% by 22.79%.
    Proportion of responders (defined as a meaningful reduction in depression symptoms based on PHQ-9 scores) is statistically significant.This proportion was found to be statistically significant at p < 0.0001.
    Mean change in PHQ-9 scores from baseline to endpoint is statistically significant.The mean change in PHQ-9 scores from baseline to endpoint was -10.0 ± 6.6 (indicating improvement).
    30% or more patients attain remission of MDD symptoms (defined as post-treatment PHQ-9 of <5).30.0% attained remission of MDD symptoms.

    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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