(142 days)
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.
| Performance Metric (Acceptance Criteria are inferred as demonstrating superiority over sham) | Reported Device Performance (Active TMS vs. Sham) | P-Value (Favoring Active TMS) | Adjusted Odds Ratio (95% CI) or Standardized Effect Size (95% CI) |
|---|---|---|---|
| Remission Rate (Primary Outcome) | 13.4% vs. 5.0% | 0.0173 | 4.05 (1.28-12.83) |
| HAMD24 Change Score | Active: 26.4 (Baseline) to 21.8 (End of Acute Phase) | ||
| Sham: 26.6 (Baseline) to 23.5 (End of Acute Phase) | 0.0588 | Treatment Effect: -2.11 (-4.30, 0.08) | |
| Standardized Effect Size: -0.43 | |||
| MADRS Change Score | Active: 29.6 (Baseline) to 24.8 (End of Acute Phase) | ||
| Sham: 29.9 (Baseline) to 27.9 (End of Acute Phase) | 0.0136 | Treatment Effect: -3.41 (-6.12, -0.71) | |
| Standardized Effect Size: -0.51 | |||
| CGI-S Change Score | Active: 4.6 (Baseline) to 4.0 (End of Acute Phase) | ||
| Sham: 4.6 (Baseline) to 4.3 (End of Acute Phase) | 0.0181 | Treatment Effect: -0.36 (-0.65, -0.06) | |
| Standardized Effect Size: -0.52 | |||
| IDS-SR Change Score | Active: 41.1 (Baseline) to 32.7 (End of Acute Phase) | ||
| Sham: 40.5 (Baseline) to 37.1 (End of Acute Phase) | 0.0008 | Treatment Effect: -6.46 (-10.19, -2.74) | |
| Standardized Effect Size: -0.67 | |||
| MADRS Remission Rate | Higher rates for active TMS (specific percentage not given) | 0.0170 | Not explicitly stated |
| IDS-SR Remission Rate | Higher rates for active TMS (specific percentage not given) | 0.1199 (not statistically significant at p |
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.