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The CloudTMS for OCD is intended to be used as an adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD).

The CloudTMS for OCD 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 bilateral dorsomedial prefrontal cortex (DMPFC) for the treatment of Obsessive-Compulsive Disorder (OCD).

The CloudTMS for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. In the OCD treatment protocol, the repetitive transcranial magnetic pulses are applied at a frequency of 20 Hz.

The CloudTMS for OCD consists of the following main components:

• . Mobile console
• Cooling unit .
• Extra power supply unit ●
• System software with GUI ●
• Treatment chair*
• Head support system*
• Coil DCC-03-125-C for both MT and treatment ●
• K8 Coil fixture
• K3 flexible arm coil positioning system ●
• Data Management System ●
• Trolley with casters .
• (* optional)

The acceptance criteria and study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The provided document describes a non-clinical performance study to demonstrate substantial equivalence to a legally marketed predicate device (Tonica Electronik A/S, MagVenture TMS Therapy System for Treatment of OCD, K193006). The study primarily focused on comparing the technological characteristics of the new device (CloudTMS for OCD) with the predicate device.

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

No test set of patient data was used. This was a non-clinical study focused on device characteristics and substantial equivalence, not a clinical trial with patient outcomes. Therefore, data provenance is not applicable in this context.

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):

Not applicable. No ground truth was established by experts for a test set of patient data, as this was a non-clinical substantial equivalence submission.

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

Not applicable, as no external 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:

Not applicable. This was not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable, as this is a medical device, not an algorithm, and the focus was on hardware and operational parameter equivalence.

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

For this substantial equivalence application, the "ground truth" was the established and legally marketed predicate device (K193006) and its characterized technological parameters as specified in its FDA clearance. The new device's performance was compared against these established specifications.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable, as no training set was used.

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