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The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.

The Ultimate rTMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder.

It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.

The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

Area of the brain to be simulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.

This 510(k) clearance letter details the substantial equivalence of the Ultimate rTMS device to its predicate devices, Mag Vita TMS Therapy System. The provided information primarily focuses on non-clinical performance and technological comparisons, rather than a clinical trial with human subjects. Therefore, some information requested in your prompt regarding clinical study elements (like sample size for test sets, ground truth establishment for test sets, expert adjudication, or MRMC studies) is not explicitly detailed or applicable in the provided document.

Here's the breakdown of the acceptance criteria and the study (non-clinical performance tests) that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table, but rather implied through the "Equivalence Comments" in the "Technological Comparison" and the "Non-clinical and/or Clinical Tests Summary & Conclusions" sections. The core acceptance criterion is substantial equivalence to the predicate devices, meaning the Ultimate rTMS device performs similarly and does not raise new safety or effectiveness concerns.

Here's a table summarizing the key performance metrics and their comparison to predicates, which serve as the "acceptance criteria" through equivalence:

Study Details (Non-Clinical Performance Tests)

The document refers to non-clinical performance tests rather than a clinical study with human participants. These tests were conducted to demonstrate the substantial equivalence of the Ultimate rTMS device to its predicate devices concerning its physical and electrical characteristics.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set: No specific "sample size" of devices or units is mentioned for the non-clinical tests. These are typically characterization tests performed on representative units of the device and its components (coils).
   • Data Provenance: The data originates from internal tests conducted by Brain Ultimate, Inc., or its contracted labs, as indicated by the "Coils Test Report" mentioned. The country of origin is not explicitly stated but implied to be where Brain Ultimate, Inc. operates (Alpharetta, GA, United States). These are prospective engineering tests performed specifically for this 510(k) submission.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This question is not applicable as the "ground truth" for non-clinical performance tests is established by engineering and physics principles, not expert human interpretation of medical images or patient outcomes. The "ground truth" is typically the measured physical properties themselves, compared against established ranges or predicate device specifications.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where human experts interpret data (e.g., radiology reads) and their agreement/disagreement needs resolution. For non-clinical performance tests, measurements are taken by instruments, and compliance is determined by comparing measured values against predefined engineering specifications and predicate device data.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, this was not done. The document explicitly states "Non-Clinical and/or Clinical Tests Summary & Conclusions," and the subsequent details focus entirely on non-clinical performance (electric/magnetic field characteristics, safety standards, etc.). There is no mention of a human reader study or clinical effectiveness trial for the Ultimate rTMS device in this 510(k) summary. Therefore, an effect size of how human readers improve with AI vs. without AI assistance is not applicable here.

5. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

   • Yes, in essence, the non-clinical performance studies represent a standalone evaluation. The device's physical and electrical characteristics are evaluated intrinsically, without human interaction influencing the outputs or measurements. The software mentioned (part of the TMS stimulator) enables the device's function, and its performance (e.g., maintaining pulse stability) is tested as part of the overall system.

6. Type of Ground Truth Used:

   • For the non-clinical tests, the "ground truth" is objective physical measurements and established engineering parameters. These include:
     • Measured electrical and magnetic field characteristics (amplitude, waveform, pulse width, field strength, dB/dt).
     • Compliance with recognized international standards (IEC 60601-1, IEC 60601-1-2).
     • Comparison to the established performance characteristics of the legally marketed predicate devices.

7. Sample Size for the Training Set:

   • Not applicable. This device is a hardware system, not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The "knowledge" embedded in the device comes from engineering design, specifications, and physical principles, not machine learning from a dataset.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, there is no "training set" or corresponding ground truth establishment process for a machine learning model. The device's functionality is based on its physical construction and control software.

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