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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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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 medication in the current episode.

The Ultimate rTMS is composed of stimulation generator and stimulation coil. The stimulation generator contains a high voltage energy storage capacitor charging and discharging system, an auxiliary power supply, a microcomputer control system, and a cooling system. The stimulation coil is composed of a stimulation coil, a cooling system, a data collection system, and a communication system.

• Magnetic Stimulator
• Cooling unit
• Coils
  • Coil Figure-of-eight coil (BF90A)
  • Coil Figure-of-eight coil (BY90A)
  • Coil Figure-of-eight coil-With angle 120°(BY90B)
• Trolley (optional)
• Coil holder (optional)
• PC (optional)
• PC keyboard (optional)

The provided text describes a 510(k) premarket notification for the Brain Ultimate, Inc. Ultimate rTMS device. The main purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a full clinical study with acceptance criteria.

Therefore, the document does not contain an acceptance criteria table from a clinical trial, nor does it describe a study specifically designed to prove device performance against such criteria. Instead, it focuses on non-clinical performance data and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document as it is a 510(k) submission primarily focused on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific set of clinical acceptance criteria for a new clinical indication. The document presents a side-by-side comparison of the Ultimate rTMS with predicate devices, outlining technical specifications and treatment parameters, not clinical acceptance criteria.

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

This information is not applicable/provided as the submission states: "CLINICAL PERFORMANCE DATA: Not applicable. Clinical performance data was not relied upon to demonstrate substantial equivalence." The testing described is non-clinical performance data related to electrical safety, electromagnetic compatibility, biocompatibility, software verification/validation, risk management, and magnetic field characteristics. These tests do not involve human subjects or clinical data sets in the traditional sense of a "test set" for performance evaluation.

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/provided. Since no clinical performance data was relied upon and no "test set" with ground truth established by experts is mentioned, this information is not relevant to this 510(k) submission.

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

This information is not applicable/provided. No clinical test set requiring adjudication is described.

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

This information is not applicable/provided. The device is an rTMS system for Major Depressive Disorder treatment, not an AI-assisted diagnostic or interpretative device that would typically involve human readers or MRMC studies.

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

This information is not applicable/provided. The Ultimate rTMS is a physical medical device (repetitive transcranial magnetic stimulation system), not a standalone algorithm. Its software is mentioned as undergoing verification and validation, but this refers to the software controlling the device, not a standalone performance evaluation.

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

This information is not applicable/provided. As stated, "Clinical performance data was not relied upon to demonstrate substantial equivalence." Non-clinical tests were performed against established standards (e.g., IEC 60601-1, ISO 10993-1, ISO 14971) and against the characteristics of predicate devices. "Ground truth" in the context of clinical performance is not discussed.

8. The sample size for the training set

This information is not applicable/provided. No machine learning or AI algorithm requiring a training set is described for performance evaluation in the supplied text.

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

This information is not applicable/provided. As no training set is described, the method for establishing its ground truth is also not applicable.

Summary of the Study and Device Proof of Meeting Criteria (based on provided text):

The document describes a 510(k) premarket notification for the Ultimate rTMS device. The "study" referenced is a combination of non-clinical performance testing and a comparison to legally marketed predicate devices to demonstrate substantial equivalence, not to prove the device meets specific clinical acceptance criteria in a de novo clinical trial.

The non-clinical performance data included:

• Electrical safety and electromagnetic compatibility testing: Compliance with IEC 60601-1:2012 and IEC 60601-1-2: 2014.
• Biocompatibility evaluation: The positioning cap meets ISO 10993-1:2018 standards.
• Software verification and validation testing: Demonstrated that the software performs as intended and in accordance with specifications, following FDA software guidelines.
• Risk management: Identified and evaluated potential risks in compliance with ISO14971:2019, with risks determined acceptable or addressed.
• Magnetic field characteristics testing: Conducted in accordance with FDA's "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems." This included testing linearity of output levels, magnetic field strength gradients, output waveform, and magnetic field spatial distribution for the Ultimate rTMS coils against a predicate device.

The demonstration of meeting "acceptance criteria" is primarily centered on showing that the Ultimate rTMS is substantially equivalent to predicate devices (MagVita TMS Therapy System, K171481, and Rapid² Therapy System, K143531). This equivalence is based on:

• Identical intended use/indication for use: Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
• Identical treatment parameters: Recommended standard treatment (Magnetic Field Intensity, Frequency, Train duration, Inter-train interval, Number of trains, Magnetic Pulses per Session, Sessions/week, Treatment Schedule, Area of brain to be stimulated).
• Similar technological characteristics: Both use the same mechanism of action (electromechanical instrument producing pulsed magnetic fields to induce electrical currents in the prefrontal cortex).
• Comparison of coils: All coils share the same figure-of-eight transducer design and air core material. Differences in coil dimensions, windings, and cooling mechanisms were analyzed and deemed not to impact safety or effectiveness.
• Comparison of machine output parameters: Amplitude, waveform (biphasic sinusoid for all), active pulse width, pulse amplitude, max magnetic field strength, and max initial dB/dt were compared and deemed substantially equivalent, with minor differences not impacting safety or effectiveness. For instance, the Ultimate rTMS has a slightly lower intensity setting to achieve the same induced current as the predicate device, which is compensated for by adjusting intensity settings for 120% MT treatment. Coil temperature safety shut-off (40°C for Ultimate rTMS vs 41°C for predicate) was considered a slightly enhanced safety feature.
• Compliance with relevant standards: ISO 13485, ISO 10993-1, ISO 14971, IEC 60601-1, and IEC 60601-1-2.

The conclusion is that based on the non-clinical testing and side-by-side comparison, the Ultimate rTMS is substantially equivalent and does not introduce new safety concerns compared to the predicate devices.

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Horizon 3.0 TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

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 depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

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

The provided text is a 510(k) summary for the Magstim Horizon 3.0 TMS Therapy System. It states that the device is substantially equivalent to a predicate device and does not involve clinical data from a new study. Therefore, the information typically requested regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance for a new study validating the device's performance against acceptance criteria is not present. Instead, the submission relies on demonstrating equivalence to previously cleared devices based on technological characteristics and existing clinical evidence for those predicates.

However, I can extract and format information regarding the basis for this substantial equivalence claim, particularly focusing on the non-clinical testing performed to show equivalence of the magnetic and electric fields, which serves as a proxy for meeting performance criteria for the extended indication.

Here's a breakdown of the information that can be extracted, and where the requested details are not applicable or provided:

1. A table of acceptance criteria and the reported device performance

The submission does not present a formal "acceptance criteria table" with numerical thresholds directly met by the subject device's performance. Instead, the performance is demonstrated by showing "equivalence" to a predicate device. The key performance metrics discussed are related to magnetic and electrical field characteristics.

Table: Comparative Performance Criteria (demonstrated by equivalence to predicate)

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

• Non-clinical Testing:
  • Sample Size for Magnetic/Electric Field Comparative Testing: Not specified in terms of "samples." This involves physical measurements and computational modeling of the devices themselves rather than a dataset of patient outcomes.
  • Data Provenance: The testing was conducted by Magstim and involved direct comparison of their device (Horizon 3.0) with the predicate (NeuroStar Advanced Therapy System). No country of origin for a data set is specified as it's not a patient-based study. This was primary testing to support the submission (prospective, in a sense, as it was done for the 510(k)).
• Clinical Data (referenced for equivalence, not a new study): The submission explicitly states, "No new clinical data is being leveraged for this 510(k) submission." Instead, it relies on clinical data from previous clearances of the predicate devices (e.g., K220127 for anxiety indication of NeuroStar Advanced Therapy System) and the subject device itself for the MDD indication (K211389, K183376, etc.). A retrospective open-label study is mentioned (Oliveira-Maia, Garcia-Guarniz, et al.) comparing Magstim and NeuroStar treated patients, but details on its sample size or provenance are not provided within this document.

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

This is not applicable for this type of 510(k) submission. Ground truth, in the direct sense of expert labels on clinical data, was not established for a new clinical test set. The submission relies on non-clinical comparative testing and the clinical validity established by the predicate device's existing clearances.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring expert adjudication was part of this 510(k) 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 Transcranial Magnetic Stimulation system, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable. This is a hardware/software medical device. While it contains software, its performance is evaluated as an integrated system for delivering TMS therapy, not as a standalone algorithm in the sense of AI for image analysis. The "standalone" performance here refers to the device's ability to generate the specified magnetic and electric fields, which was confirmed through non-clinical testing.

7. The type of ground truth used

For the non-clinical testing:

• The "ground truth" for the magnetic and electric field comparisons was established by direct physical measurements and finite element modeling (FEM) based on established scientific principles and FDA guidance.
• For the clinical indications, the "ground truth" (i.e., that the therapy is safe and effective for the stated indications) is based on the previously cleared clinical evidence for the predicate device (NeuroStar Advanced Therapy System K220127) and earlier clearances for the Magstim device for MDD. This is not "ground truth" generated by this submission directly, but rather relied upon from existing regulatory frameworks.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" in the context of machine learning or AI models within this 510(k) summary. The "training" for this device would refer to the engineering and design process, and the "data" would be the specifications and test results.

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

Not applicable. As per point 8, there's no mention of a training set in the context this question implies.

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