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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 FDA cleared Brainsway Deep TMS System is composed of the following main components: 1. An Electromagnetic Coil 2. A TMS Neurostimulator 3. A Cooling System 4. A Positioning Device 5. A Cart

This document is a 510(k) premarket notification for the Brainsway Deep TMS System. It focuses on demonstrating substantial equivalence to a previously cleared device (K122288), also from Brainsway Ltd., rather than presenting a de novo study with explicit acceptance criteria for a novel device performance claim. Therefore, the information requested in the prompt, which is typically found in clinical studies establishing the efficacy and safety of a new device, is largely not applicable or not provided in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for diagnostic/AI performance, nor does it report specific device performance metrics in that context. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence for modifications to an existing device.

From the text, the performance aspects evaluated are primarily related to safety and technical specifications:

• Output Waveform
• Electrical Field Spatial Distribution
• Magnetic Field Strength Gradient Testing
• Software validation testing (compliance with FDA guidelines and IEC 62304)
• Compliance with electrical and mechanical safety, electromagnetic compatibility, and software validation standards (IEC 60601-1, IEC 60601-1-2, IEC 62304).

The reported performance is that these characteristics are substantially equivalent to the predicate device and that the device complies with the mentioned standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as this submission is for modifications to an existing device, and the testing described is non-clinical (bench testing) and software validation. No new clinical test set (i.e. patients for diagnostic performance evaluation) was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. There was no clinical test set requiring expert-established ground truth for performance evaluation of a new diagnostic claim. The "ground truth" here is the established safety and performance of the predicate device and relevant international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No clinical test set requiring adjudication was used.

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

A MRMC comparative effectiveness study was not done. The device is not an AI-assisted diagnostic tool but a therapeutic device (Repetitive Transcranial Magnetic Stimulation System).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a therapeutic system, not an algorithm for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for the device's technical performance and safety is its conformance with recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 62304) and demonstration of substantial equivalence to a previously cleared predicate device in terms of:

• Output Waveform
• Electrical Field Spatial Distribution
• Magnetic Field Strength Gradient
• Software validation

Safety and effectiveness are established by showing that modifications do not introduce new hazards and that the device operates within established parameters, which are deemed safe and effective based on the predicate device's clearance.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device requiring a training set in the conventional sense. The "training" for the device's development and validation would refer to engineering design, testing iterations, and software development, not a data-driven machine learning training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

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