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For Adults: Horizon 3.0 TMS Therapy Systems are indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation 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. ("TMS").

The Horizon® 3.0 TMS 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 prior antidepressant medication in the current episode
• as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
• as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15--21)

The Horizon® 3.0 TMS 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 Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and accessories.

The Horizon® 3.0 TMS Therapy System is offered in three configurations:

• Horizon 3.0 Inspire (Cleared under K241518). -
• Horizon 3.0 (Cleared under K232235, K223154, K222171 and K211389), -
• Horizon 3.0 with StimGuide Pro (Cleared under K232235).

The three tiers of system offer equivalent safety and effectiveness with the main purpose allowing for physician offices, clinics and hospitals to choose a configuration that suits the organizational needs and provide different entry levels to promote the accessibility of TMS Therapy Treatments to health delivery organizations.

All three configurations have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation.

All configurations are composed from the following main components:

• Stimulating Unit & Power Supply -
• User Interface
• Applicating Coil for Motor Threshold -
• -Applicating Coil for Treatment Delivery
• -System and Applicating Coil Cart and Holding Arm

The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

Below is a summary of the acceptance criteria and the study that proves the device meets the criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The summary details a series of non-clinical tests. These tests primarily involve physical measurements and simulations, rather than collecting data from human subjects.

• Sample Size for Test Set: Not applicable in the traditional sense of human subjects. For the magnetic and electrical field testing, the "test set" was the physical setup involving a phantom head model and specific coils. No numerical sample size for patients is provided.
• Data Provenance: The data comes from in-house engineering and laboratory testing performed by The Magstim Company Limited, in accordance with international standards. This is not retrospective or prospective clinical data from human patients, but rather performance data generated from the device itself and its components. The country of origin for the testing is implicitly the United Kingdom, where the applicant is located.

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

Given the nature of the non-clinical tests described, the concept of "experts establishing ground truth" for a test set in a human clinical context is not directly applicable.

• Magnetic and Electrical Field Testing: This testing involved physical measurements using a phantom head model and measuring probes. The "ground truth" here is the physical output of the device under controlled conditions, measured against established scientific principles and comparison to a legally marketed predicate device. The expertise involved would be in engineering, physics, and medical device testing, ensuring the test setup, execution, and interpretation of results are scientifically sound and comply with regulatory guidance.
• Other Non-Clinical Tests: For areas like Electrical, Mechanical, Thermal Safety, EMC, Software V&V, Usability, Safety Features, and Acoustic Testing, compliance is determined by adherence to specific international standards (e.g., IEC 60601 series, IEC 62304, ISO 10993, AAMI/ANSI HE75) and FDA guidance documents. The "ground truth" is defined by these standards and the expertise lies with the engineers and quality assurance personnel who conduct these tests and verify compliance.

No specific number or qualifications of "experts" are provided in the summary, as this is typically inherent in the regulatory-compliant testing process conducted by the manufacturer.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where ambiguous cases require expert consensus. The tests described here are non-clinical, objective measurements and compliance checks against established standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "Clinical Testing - Not Applicable." The submission relies solely on non-clinical testing to demonstrate substantial equivalence.

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

This question is not entirely applicable as the device in question (Horizon 3.0 TMS Therapy System) is a hardware-based medical device that delivers magnetic stimulation. While it contains software, it is not an AI algorithm that generates diagnostic outputs or interpretations that would typically have a "standalone" performance metric in the absence of human input or a human-in-the-loop. The software functions to control the hardware and deliver therapy protocols, and its performance is validated as part of the overall device system.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is primarily based on:

• Compliance with International Standards: The device's performance is measured against established safety, EMC, thermal, electrical, mechanical, and software standards (e.g., IEC 60601 series, IEC 62304).
• Scientific Principles and Physical Measurements: For magnetic and electrical field testing, the ground truth is derived from quantitative physical measurements conducted in a controlled phantom head model according to scientific principles.
• Comparison to a Legally Marketed Predicate Device: Substantial equivalence is established by demonstrating that the subject device's performance characteristics (e.g., magnetic field output, treatment protocols) are equivalent to those of the predicate device (NeuroStar Advanced Therapy System) and previously cleared Magstim devices.

There is no pathology, expert consensus (in a diagnostic sense), or outcomes data from human patients used as ground truth in this submission, as it focuses on non-clinical performance.

8. The Sample Size for the Training Set

Not applicable. This device is a medical device for therapy, not a machine learning model that requires a distinct "training set" of data in the AI sense. The software embedded in the device is developed and validated through traditional software engineering practices (IEC 62304), not through machine learning training on a dataset.

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

Not applicable, as there is no machine learning "training set" for this device. The software development and validation followed established engineering principles and regulatory standards (IEC 62304), which ensure the software functions as intended and meets safety requirements.

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Horizon® 3.0 TMS 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Horizon® 3.0 TMS 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. ("TMS").

The Horizon® 3.0 TMS 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 prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.

The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and configurations:

• Horizon 3.0 Inspire (Subject of this submission).
• Horizon 3.0 (Previously cleared under K232235, K223154, K222171 and K211389).
• Horizon 3.0 with StimGuide Pro (Cleared under K232235).

All three configurations, including the subject Horizon 3.0 Inspire configuration, have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation.

All configurations are composed from the following main components:

• Stimulating Unit & Power Supply
• User Interface
• Applicating Coil for Motor Threshold
• Applicating Coil for Treatment Delivery
• System and Applicating Coil Cart and Holding Arm

The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

The provided text is a 510(k) summary for the Horizon 3.0 TMS Therapy System, specifically introducing the "Horizon 3.0 Inspire" configuration. This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K232235, Horizon 3.0 TMS Therapy System) rather than presenting a standalone study with defined acceptance criteria and performance metrics against a specific clinical outcome.

Therefore, the requested information, particularly regarding acceptance criteria for clinical performance, sample sizes for test sets where ground truth was established by experts, and effect sizes for MRMC studies, is not present in this document. The document describes non-clinical testing to demonstrate that the new configuration is as safe and effective as the predicate device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes compliance with various safety and performance standards, but does not present a table of acceptance criteria with corresponding performance results in a way that would typically be seen for a new clinical efficacy study. Instead, it refers to demonstrating equivalence to a predicate device through non-clinical testing.

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

• Test Set: No patient-specific test set for clinical performance is mentioned. The testing described is non-clinical/bench testing.
• Data Provenance: The data provenance is from laboratory testing performed by the manufacturer, comparing the new configuration's performance to the primary predicate device and relevant standards. This is retrospective in the sense that it relies on existing standards and predicate device data, but the tests themselves were conducted on the new device configuration.

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 as the document describes non-clinical testing against engineering standards and comparison to a predicate device, not a human reader study where experts establish ground truth for a clinical dataset.

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

This information is not applicable for the same reasons as point 3.

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:

No MRMC comparative effectiveness study was done or described. This is a device for Transcranial Magnetic Stimulation, not typically an imaging AI device that aids human readers in interpretation.

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

The device itself is a standalone medical device for delivering TMS therapy. The described testing is of the device's technical specifications and safety profile, not of an "algorithm only" in the context of an AI diagnostic. The software components were verified and validated as part of the overall device system.

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

For the non-clinical tests described, the "ground truth" (or reference) used were:

• International standards: (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62366-1, ANSI/AAMI HE75, ISO 10993-1, ISO 10993-10, ISO 14971, IEC 62304, AAMI TRS7, AAMI TIR97).
• Performance of the legally marketed predicate device (K232235): The goal was to demonstrate "equivalent" safety and effectiveness.
• Phantom head model: For Magnetic and Electrical Field Testing, a human head phantom model filled with physiologic saline solution was used to measure induced voltage.

8. The sample size for the training set:

This information is not applicable. This document does not describe the development or training of a machine learning algorithm; it describes a hardware and software system for TMS therapy.

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

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

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