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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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