(679 days)
The BrainsWay Deep TMS™ 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 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 to 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:
- Cart
a) TMS Neurostimulator
b) Cooling System
c) Positioning Device - Helmet
a) Aiming Apparatus (i.e., ruler/grid)
b) Electromagnetic Coil (H Coil)
c) Cap
The provided text is a 510(k) summary for the BrainsWay Deep TMS™ System, seeking to enable modifications to the device labeling based on clinical data. It is important to note that this document does not describe an AI medical device that has acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and a study proving those criteria were met via a test set adjudicated by experts. Instead, this document details a study for a therapeutic device (Transcranial Magnetic Stimulation System) and focuses on clinical outcomes (remission and response rates for Major Depressive Disorder (MDD)).
Therefore, I cannot fulfill all parts of your request as it pertains to an AI medical device's performance study. However, I can extract the relevant information about the clinical studies conducted for the BrainsWay Deep TMS™ System's expanded indication for use.
Here's an analysis based on the provided text, adapted to the context of a therapeutic device rather than a diagnostic AI:
Acceptance Criteria and Study for BrainsWay Deep TMS™ System
This 510(k) submission primarily focuses on expanding the indicated adult population for the BrainsWay Deep TMS™ System to include adult subjects >22 and 60 years old).
- Real-World Data (RWD):
- Total Patient Records: 1,198 patients
- Source: Electronic health records from 20 sites over the US.
- Time Span: 2012 to 2022 (10 years).
- ITT Patient Population Analysis (met eligibility criteria): 152 subjects
- Population: Elderly MDD patients (>69 years old: mean age 73.6, range 69-86).
- Provenance: Retrospective, from the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is a clinical efficacy study for a therapeutic device, not an AI diagnostic device. Therefore, the concept of "ground truth" established by experts for a test set (e.g., radiological reads) as would be the case for an AI diagnostic device, does not apply here.
- Clinical outcomes (HDRS-21, CGI-S, PHQ-9 scores) are typically rated by trained clinicians (e.g., psychiatrists, psychologists). The document does not specify the number or qualifications of clinicians involved in assessing these scores for the Kaster 2018 Study or the RWD. It mentions that approximately 50% of RWD patients were treated by providers with >10 years or
§ 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.