(134 days)
The Brainsway Deep Transcranial Magnetic Stimulation System is indicated to be used as an aid in short-term smoking cessation for adults.
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 scap. 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 FDA cleared Brainsway Deep TMS System is composed of the following main components:
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- Electromagnetic Coil
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- TMS Neurostimulator
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- Cooling System
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- Positioning System and Helmet
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- Cart
Here's an analysis of the acceptance criteria and study detailed in the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Brainsway Deep TMS System (with HADD-coil) for short-term smoking cessation were primarily based on the statistical significance and clinical meaningfulness of the 4-week Continuous Quit Rate (CQR), supported by secondary endpoints.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Statistically significant and clinically meaningful higher 4-week Continuous Quit Rate (CQR) in the DTMS arm compared to the sham arm. | Primary Endpoint: The 4-week CQR was statistically significantly higher (p-value = 0.0238) in the DTMS arm (17.1%) than in the sham arm (7.9%) for the ITT-Safety population (N=262) up to 4 months follow-up. This was considered clinically meaningful. |
| Secondary Endpoint: Statistically significant higher 4-week CQR in subjects with at least 4 weeks of diary records. | Secondary Endpoint: The 4-week CQR was statistically significantly higher (p-value = 0.0071) in the DTMS arm (27.3%) compared to the sham arm (11.3%) for subjects with at least 4 weeks of diary records. |
| Secondary Endpoint: Statistically significant lower number of cigarettes smoked per day (per diary entry) in the DTMS treatment arm compared to the sham arm. | Secondary Endpoint: The number of cigarettes smoked per day (per diary entry) was statistically significantly lower in the DTMS treatment arm compared to the sham arm (specific p-value not given for this point, but stated as statistically significant). |
| Secondary Endpoint: Statistically significant higher 4-week CQR up to the 6th week visit. | Secondary Endpoint: The 4-week CQR up to the 6th week visit was statistically significantly higher (p-value = 0.0022) in the DTMS arm (15.4%) than in the sham arm (4.3%). |
| Safety Profile: No individual adverse event types with a significant difference between study groups, except for expected application site discomfort and muscle twitching. | Safety Profile: No individual adverse event types showed a significant difference between groups, except for application site discomfort and muscle twitching. Heading reporting was not statistically significant. Application site discomfort (11.38% vs 2.16%, p=0.0043) and muscle twitching (5.69% vs 0%, p=0.0046) were higher in the DTMS group but were not considered to deter treatment. |
Study Details Proving Acceptance Criteria
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: N=262 (ITT-Safety population), with 123 subjects in the DTMS arm and 139 subjects in the sham arm.
- Data Provenance: The study was a "prospective, double blind, randomized, sham controlled, multi-center trial." No specific countries of origin for the data are explicitly stated, but multi-center typically implies multiple sites, which could be in one or more countries. It is a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the "ground truth" establishment by independent experts for the smoking cessation outcomes. The ground truth for effectiveness (smoking cessation) was determined by objective measures like Continuous Quit Rate (CQR) based on participant self-reporting and likely biochemical verification (though not explicitly stated for this 510(k) summary, it's common in smoking cessation trials). The study was clinically managed, but the role of external experts in adjudicating individual cases of "quit" status is not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the test set outcomes (i.e., whether participants met the smoking cessation criteria). The outcomes appear to be derived from direct data collection (e.g., self-reported smoking diary, likely backed by CO-oximetry or similar biochemical tests, though not mentioned in this excerpt) rather than subjective expert interpretation requiring adjudication.
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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. This device is a treatment device (Transcranial Magnetic Stimulation), not an AI diagnostic or assistance tool that would involve human readers interpreting cases.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The Brainsway Deep TMS System is a medical device for treatment, not an algorithm, and it is designed for use by a human operator (clinician) to administer the therapy. Its performance is as a therapeutic device, not an AI or algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for device efficacy was outcomes data directly from the clinical trial, specifically the 4-week Continuous Quit Rate (CQR) for smoking cessation, along with other self-reported and indirect measures of smoking behavior (e.g., number of cigarettes per day).
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The sample size for the training set:
- This question is not applicable. This is a medical device for treatment, not an AI or machine learning model that requires a "training set." The clinical trial data (N=262) served as the validation for its efficacy for the stated indication.
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How the ground truth for the training set was established:
- This question is not applicable as there is no "training set" in the context of this traditional medical device validation.
§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.