(158 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 (TMS Neurostimulator, Cooling System, Positioning Device), and Helmet (Aiming Apparatus, Electromagnetic Coil (H7 Coil), Cap).
The provided text from the FDA 510(k) summary does not contain acceptance criteria or a study that directly proves the device meets those specific criteria in the way typically seen for AI/ML devices with quantitative performance metrics.
Instead, the document details a non-inferiority study to demonstrate that a modified version of a device (BrainsWay Deep TMS™ System with H7 Coil) is as safe and effective as a previously cleared predicate device (BrainsWay Deep TMS™ System with H1 Coil). The "acceptance criteria" in this context are implicitly that the new device performs at least as well as the predicate device within a defined non-inferiority margin for key clinical outcomes.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-inferiority Limit) | Reported Device Performance (H7 vs H1 Coil) |
|---|---|
| Upper limit of one-sided 95% CI for the difference in change from baseline in HDRS-21 at 6 weeks is lower than 3 (non-inferiority limit). | Upper limit of one-sided 95% CI was 1.9. |
| No statistically significant difference in response rates and remission rates at week 6. | Response rates and remission rates at week 6 were not statistically significantly different. |
| No statistically significant difference in the incidence of adverse events. | No statistically significant difference in the incidence of any adverse events reported. |
2. Sample size used for the test set and the data provenance
- Sample size: 169 subjects total.
- Specific breakdown by H7 and H1 coil groups is not explicitly stated, but the study was a "Randomized Controlled Trial," implying subjects were divided between these two groups.
- Data provenance: Prospective, Multicenter. Country of origin not specified, but the study was titled "Multicenter H7 vs H1 Study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The "ground truth" in this study relates to clinical outcomes over time (e.g., changes in HDRS-21 scores). These scores are typically assessed by trained clinicians, often psychiatrists or psychologists, but the exact number of experts or their specific qualifications for this study are not detailed in the provided text. Scores like HDRS-21 are standardized clinical assessments, not typically "established" by multiple experts for each patient like in imaging adjudication.
4. Adjudication method for the test set
Not explicitly stated. Clinical rating scales like HDRS-21 are usually administered by trained raters, potentially with inter-rater reliability checks, but a formal adjudication method like "2+1" or "3+1" is not mentioned as it would be for diagnostic imaging studies.
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, this was not an MRMC comparative effectiveness study involving human readers with or without AI assistance. It was a clinical trial comparing two different device configurations (H7 coil vs. H1 coil) for direct patient treatment. The device itself is a treatment system, not a diagnostic AI tool. Therefore, an effect size of human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a deep transcranial magnetic stimulation (TMS) system for treating Major Depressive Disorder, not an algorithm or AI system used for diagnosis or image analysis in a standalone capacity.
7. The type of ground truth used
The ground truth used was clinical outcome data from patient assessments, specifically changes in the Hamilton Depression Rating Scale (HDRS-21) and Hamilton Anxiety Rating Scale (HARS) scores, as well as response and remission rates. These are standard measures of treatment efficacy in psychiatry.
8. The sample size for the training set
Not applicable. This device is a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "study" described (CTP-0002-00) is a clinical trial to demonstrate safety and effectiveness for regulatory approval.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.