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The NeuroStar TMS 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 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec (nominal)) 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 or TMS. NeuroStar TMS 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 as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.

The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS Therapy™. The Head Support System provides accurate positioning of the Treatment Coil using a laserguided alignment system. A single-use device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient. The TMS TrakStar™ practice data management system consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.

Here's an analysis of the NeuroStar TMS Therapy System based on the provided text, focusing on acceptance criteria and the study proving its effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance thresholds for the device. Instead, it focuses on demonstrating statistically significant advantage and moderate to large treatment effects compared to a sham control. The primary outcome measure (remission rate) and secondary continuous outcomes (change scores) serve as the de-facto performance metrics.

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

• Sample Size (Test Set): N=197 adult patients.
  • Active TMS: N=97
  • Sham TMS: N=100
• Data Provenance: The study was a "multi-site" trial, implying data from various clinical sites. The document doesn't specify the country of origin, but given the FDA submission context, it's highly likely to be U.S.-based or a multi-national trial including U.S. sites. The study is described as a prospective, randomized, controlled trial (OPT-TMS RCT).

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

The ground truth was established by clinical assessment using standardized scales (HAMD24, MADRS, CGI-S, IDS-SR) conducted by "clinical personnel" at the various study sites. The document does not specify the "number of experts" or the "qualifications of those experts" (e.g., radiologist with 10 years of experience) in the way one might for diagnostic image interpretation. Instead, clinical scales are inherently designed for trained clinicians to apply. The HAMD24, for instance, is a clinician-rated scale.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the HAMD24 or other clinical scores. It implies that these scores were assessed and recorded by the clinical teams at each site as part of the standard protocol. The primary outcome, remission, was defined based on HAMD24 scores, which would have been directly observed from the assessments.

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 conducted. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The NeuroStar TMS Therapy System is a therapeutic device, and its effectiveness was evaluated through a randomized controlled trial comparing active treatment to sham.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way. The "device" (NeuroStar TMS Therapy System) was tested in a standalone therapeutic capacity, meaning its effect was directly observed in the randomized controlled trial. While human operators are involved in administering the therapy, the study aimed to measure the therapeutic effect of the device itself compared to a sham device, not to assess an AI's diagnostic performance in an "algorithm-only" or "human-in-the-loop" scenario. The performance metrics (remission rates, change in symptom scores) directly reflect the device's therapeutic output.

7. Type of Ground Truth Used

The ground truth was based on clinical assessment using standardized, validated psychiatric rating scales. Specifically:

• HAMD24 (24-item Hamilton Depression Rating Scale): Primary measure for remission and change. Remission was defined as HAMD24 total score <3 or 2 consecutive ratings of HAMD24 total score <10.
• MADRS (Montgomery-Åsberg Depression Rating Scale)
• CGI-S (Clinical Global Impression – Severity scale)
• IDS-SR (Inventory of Depressive Symptomatology – Self-Report)

These scales serve as the expert consensus-driven, validated measures of depression severity and response to treatment.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an AI/machine learning algorithm. The NeuroStar TMS Therapy System is described as a computerized, electromechanical medical device that produces magnetic stimulation. It's a therapeutic device, not an AI diagnostic tool that would typically have a "training set" for model development. The clinical study (OPT-TMS RCT) is a validation study demonstrating the device's efficacy, not a study to train an algorithm.

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

Since there is no mention of an AI/machine learning component requiring a "training set," this question is not applicable to the information provided about the NeuroStar TMS Therapy System.

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