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The Rapid2 Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Rapid Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.

The Rapid" Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from antidepressant medication in the current episode. The Rapid-Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals.

The Rapid Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.

The document provided primarily details the substantial equivalence of the Magstim Rapid2 Therapy System to a predicate device (NeuroStar TMS Therapy System) for the treatment of Major Depressive Disorder, rather than describing a specific study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven medical device.

The "acceptance criteria" discussed here are implicitly related to demonstrating substantial equivalence for regulatory approval, focusing on technical and functional similarities with a legally marketed predicate device. The performance data mentioned are primarily non-clinical "bench testing" to ensure safety and functionality in relation to the predicate, rather than clinical performance metrics against a defined ground truth for a specific medical condition's diagnosis or prediction.

Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance against ground truth, training set details) are not applicable or not provided in the context of this 510(k) summary for a Transcranial Magnetic Stimulation (TMS) system.

However, I can extract the relevant information regarding the comparative aspects and testing performed:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't present a table of acceptance criteria and reported performance in the typical sense of a clinical trial comparing device output against a ground truth. Instead, it compares the technical specifications and operational parameters of the Rapid2 Therapy System to its predicate device, the NeuroStar TMS Therapy System, to demonstrate substantial equivalence. The "acceptance criteria" here are implicitly that the Rapid2 Therapy System's parameters should be similar to or within acceptable limits compared to the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The "testing" described is non-clinical bench testing and verification against engineering standards and comparison of technical specifications, not a clinical study on a patient sample.
• Data Provenance: Not applicable. The data primarily consists of engineering measurements and device specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., disease presence/absence determined by expert consensus or pathology) is not relevant for this type of regulatory submission focused on substantial equivalence of a treatment device. The "ground truth" here is adherence to engineering standards and similarity to the predicate device's established parameters.

4. Adjudication method for the test set:

• Not applicable. There was no clinical test set requiring adjudication in the context of this submission.

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 device is a treatment system (rTMS), not a diagnostic device involving "human readers" or AI assistance for interpretation.

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

• Not applicable. This is a treatment device, not an algorithm. The "performance" described relates to its physical and functional characteristics (e.g., magnetic field output, cooling system effectiveness, software functionality) rather than an algorithmic output. Software verification and validation were performed to ensure it "performs as intended and in accordance with specifications."

7. The type of ground truth used:

• The "ground truth" implicitly used for the non-clinical testing is adherence to established engineering standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO14971) and the established, legally marketed parameters and performance of the predicate device (NeuroStar TMS Therapy System).

8. The sample size for the training set:

• Not applicable. This is a medical device for treatment, not an AI/ML model that requires a training set of data.

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

• Not applicable, as there is no training set for this type of device.

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