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The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

The NeuroStar TMS System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 usec) 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 or TMS. The peak magnetic field strength achieved with each pulse is approximately 1.5 Tesla.

The NeuroStar TMS System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, mechanically supports the ferromagnetic Treatment Coil and includes a software controlled graphical user interface, a ferromagnetic Treatment Coil to deliver TMS Therapy, a Head Support System for accurate coil positioning, and a single use device (SenStar® Treatment Link) placed on the face of the coil to reduce local scalp stimulation, to provide feedback to the operator regarding contact of the coil with the patient's head, and to verify the applied field strength. A separate Practice Data Management System (PDMS) allows and facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS System units.

Here's an analysis of the provided text regarding the Neurometnics NeuroStar TMS Therapy System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on a 510(k) summary for a modification to an existing device (adding a Class 1 laser positioning aid). As such, it primarily discusses the equivalence of the modified device to the predicate device, rather than establishing de novo acceptance criteria for the core therapeutic efficacy of TMS for Major Depressive Disorder. The core efficacy would have been established during the predicate device's clearance (K061053).

However, specific acceptance criteria for the new feature (the Class 1 laser positioning aid) were mentioned.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for the test sets in the context of the laser positioning aid. It refers to "design verification tests" and "performance testing."

• Test Set Sample Size: Not specified quantitatively.
• Data Provenance: The studies mentioned ("Test Report 80-80095-001" and "Test Report 80-80095-000") are internal verification and validation studies conducted by Neuronetics, Inc. The country of origin for the data is implicitly the United States, given the company's location and FDA submission. The studies are prospective in nature, as they are verification and validation tests for a new design feature.

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

This information is not provided in the summary. The types of tests described (accuracy of positioning, equivalence in MT determination) suggest a technical evaluation rather than a clinical expert panel review for the laser component.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned for this 510(k) submission. This submission is for a device modification (adding a laser positioning aid) to a previously cleared device. The focus is on demonstrating that the new feature maintains the established safety and effectiveness, not on a new comparative effectiveness study of the TMS therapy itself. Therefore, no effect size of human reader improvement with/without AI assistance is relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device, the NeuroStar TMS Therapy System, is a medical device for treatment, not an AI or algorithm-only diagnostic tool. The "Class 1 laser positioning aid" is a hardware component with integrated circuitry and software to facilitate human operation; it is not a standalone algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this device or its new feature.

7. The Type of Ground Truth Used

For the laser positioning aid's performance, the ground truth would be based on:

• Design Specifications: For accuracy (e.g., how precisely the laser indicates a position compared to mechanical measurements or engineering requirements).
• Established Methods: For equivalence in Motor Threshold (MT) determination and TMS treatment locations. This implies comparison against the results obtained using the predicate device's existing positioning method.

8. The Sample Size for the Training Set

This information is not provided. The laser positioning aid involves embedded software and control logic, but the document does not describe it in terms of a "training set" in the machine learning context. It refers to design verification and validation, which typically involves testing against specifications and comparison to an existing standard.

9. How the Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is explicitly described, this question is not directly applicable. For the engineering verification of the laser positioning aid, the "ground truth" would be the predefined engineering specifications and criteria for accuracy and equivalence, which are established during the device design and development process.

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