(123 days)
The BrainsWay Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.
The BrainsWay Deep TMS System enables direct non-invasive activation of deep brain structures. 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 pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.
The BrainsWay Deep TMS System is composed of the following main components:
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- Cart
- a) TMS Neurostimulator
- b) Cooling System
- c) Positioning Device
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- Helmet
- a) Aiming Apparatus (i.e., ruler/grid)
- b) Electromagnetic Coil (H1-Coil)
- c) Cap
Here's a breakdown of the acceptance criteria and study information for the BrainsWay Deep TMS System with iTBS Protocol, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are established through demonstrating non-inferiority of the new iTBS protocol compared to an already FDA-cleared High Frequency (HF) protocol for the same device. The primary endpoint for non-inferiority was the change in HDRS-21 score.
| Acceptance Criteria (Study Hypothesis - Null Hypothesis) | Reported Device Performance (Summary of Results) |
|---|---|
| The mean change in HDRS-21 score from baseline at 5 weeks in the iTBS Deep TMS group is inferior to the mean change in HDRS-21 score from baseline at 5 weeks in the HF Deep TMS group, by more than 3 points. (Non-inferiority margin: 3 points) | The non-inferiority analysis of the change from baseline between the two treatment groups was assessed. Since the upper limit of the confidence interval was less than the non-inferiority margin of 3 points, the null hypothesis of inferiority was rejected, indicating non-inferiority between the iTBS Deep TMS and HF Deep TMS treatments, when adjusted for baseline HDRS-21 scores. |
| Secondary Endpoints (No specific numerical acceptance criteria mentioned, but demonstrate similar performance) | HDRS-21 Response Rate at 5 weeks, HDRS-21 Remission Rate at 5 weeks, Change in CGI-S from baseline to 6 weeks, CGI-S Response Rate at 6 weeks, CGI-S Remission Rate at 6 weeks. |
| (The document states "the change from baseline was similar between the two treatment groups at 5 weeks," implying similar performance on these secondary endpoints as well.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 146 subjects
- 66 subjects received iTBS stimulation protocol.
- 80 subjects received HF stimulation protocol.
- Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin. However, given it's a clinical study for FDA clearance, it's highly likely to be a prospective multi-center study, though the specific locations are not provided in this summary. The mention of "multicenter MDD study" for age eligibility criteria might hint at a multi-site study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This particular study does not involve establishing ground truth through expert review of specific data like images. Instead, the "ground truth" for the effectiveness of the treatment is based on patient-reported outcomes and clinician-administered scales (HDRS-21, CGI-S), which inherently involve expert clinicians in their administration and interpretation during the study.
4. Adjudication Method
Not applicable in the typical sense of radiological or pathological adjudication. The primary and secondary endpoints are based on standardized clinical assessment scales (HDRS-21, CGI-S) administered by qualified clinical personnel as part of the study protocol.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study is a clinical trial comparing two different stimulation protocols (iTBS vs. HF) on human patients for Major Depressive Disorder (MDD), not a reader study involving interpretation of cases by multiple human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a medical device for treatment, not an AI/algorithm for diagnosis or analysis where standalone performance would typically be evaluated. The "performance" being assessed is the clinical effectiveness of the device (iTBS protocol) in treating MDD. Therefore, a standalone algorithm-only performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth used for determining the effectiveness of the device in this clinical study is:
- Clinical Outcomes Data: Specifically, changes in patient depression levels as measured by established clinical rating scales (HDRS-21 and CGI-S scores) from baseline to follow-up, along with derived response and remission rates.
8. The Sample Size for the Training Set
Not applicable. This document describes a clinical study to evaluate the effectiveness of a medical device's protocol, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for a machine learning algorithm. The "training" for this device refers to the clinical application of the stimulation protocol in the context of treating patients.
§ 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.