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Ask a specific question about this device

Ask a specific question about this device

The Apollo 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 Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).

The Apollo TMS Therapy System is comprised of the following principal components:

• User Interface
• Main Unit (with or without housing)
• Stimulation Coil
• Coil Positioning System

The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. For treatment of OCD, the stimulation coil is positioned to the dorsomedial prefrontal cortex (DMPFC).

The provided FDA 510(k) clearance letter and summary for the Apollo TMS Therapy System (K243539) indicate that the device is substantially equivalent to predicate devices. This clearance is based on non-clinical performance data and a comparison to existing cleared devices rather than a de novo clinical comparative effectiveness study.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly for the extended indication of Obsessive-Compulsive Disorder (OCD) treatment. The criteria are therefore focused on matching or being demonstrably similar to the predicate device's performance, especially for the OCD treatment parameters, and adhering to recognized safety and performance standards.

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

The submission does not detail a specific "test set" sample size with patient data for efficacy, as it claims substantial equivalence primarily through non-clinical performance testing and direct comparison of specifications and treatment parameters to already cleared devices.

The "study" relies on:

• Non-clinical performance testing: This would involve engineering and laboratory testing for electrical safety, EMC, usability, temperature, and stimulation intensity, rather than a sample size of patients.
• Leveraged data from prior clearances (K180313 and K232639): This indicates that data from previously cleared versions of the Apollo TMS Therapy System was used as a basis.
• Primary predicate device (HORIZON® 3.0 TMS Therapy System K222171): The effectiveness of the OCD treatment protocol is derived from the established effectiveness of this predicate device, which was itself cleared based on its own clinical or non-clinical data.

Data Provenance: Not specified in terms of country of origin or retrospective/prospective for patient data, as direct clinical effectiveness data for the subject device was not required for this 510(k) clearance due to the substantial equivalence claim. The non-clinical testing would have been conducted by the manufacturer (MAG & More GmbH, Germany).

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

This information is not applicable as the submission does not describe a clinical study where experts established ground truth for a test set of patient data. The clearance is based on comparison to a predicate device and non-clinical engineering tests.

4. Adjudication method for the test set

This information is not applicable as there was no clinical test set requiring expert adjudication.

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. The Apollo TMS Therapy System is a therapeutic device that directly applies magnetic stimulation, not an imaging analysis or diagnostic AI device that involves "human readers" or AI assistance in interpretation. No MRMC study was conducted or mentioned.

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

This information is not applicable in the context of an "algorithm only" performance study. The Apollo TMS Therapy System is a hardware device with controlling software. Its performance is always "standalone" in the sense that the device itself (hardware+software) delivers the therapy; there isn't a separate "human-in-the-loop" performance associated with its direct therapeutic action, but rather clinical oversight and operation by a healthcare professional. The software verification and validation are noted, but this is for the control system's reliability, not an "algorithm-only performance" in the diagnostic AI sense.

7. The type of ground truth used

For the effectiveness of the OCD treatment, the "ground truth" is essentially the established clinical efficacy of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171), whose OCD treatment protocol the Apollo TMS Therapy System replicates. The substantial equivalence claim means that because the subject device's treatment parameters are identical and its output stimulation is adequately similar, it can be expected to achieve the same therapeutic effect.

For the safety and performance of the device itself (e.g., electrical safety, temperature limits, consistent stimulus delivery), the "ground truth" is established through adherence to recognized consensus standards (e.g., IEC 60601-1) and successful non-clinical engineering tests.

8. The sample size for the training set

This information is not applicable. The Apollo TMS Therapy System is not an AI/ML device in the sense of requiring a large "training set" of patient data for its primary function. Its software (Stimware) manages protocols and patient data, but it's not "trained" on patient outcomes to learn or adapt therapeutic delivery in an AI sense.

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

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

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MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15-21).

The MagVenture TMS Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp.

The pulses generate an electric field in the underlying brain tissue. When this field surpasses a specific threshold and aligns appropriately with the brain's neuronal pathways, it induces localized axonal depolarization, leading to neuron activation in the targeted brain region.

The MagVenture TMS Therapy System represents an integrated system comprised of the following components:

• Magnetic Stimulator (MagPro Family)
• Coil for motor threshold determination: C-B60, C-B70
• Treatment Coils: Cool-B65, Cool-B70, Cool D-B80
• Accessories:
  • Trolley with mounting for super flexible arm and coil holder arrangement)
  • Patient head fixation
  • Super flexible arm or Flow Arm for coil fixation
  • Isolation transformer
  • Cooler Unit
  • Caps and Marking accessory (marking plate, pen, ruler) – Beam F3 or 5.5 cm Coil Placement
  • Vacuum pump and Vacuum pillow with Pillow Case for patient head fixation (Optional)
  • Treatment Chair (Optional)
  • Coil Hub (Optional)
  • MagVenture TMS Atlas Neuro Navigation System (Optional)

Except for the Beam F3 marking plate, all components have previously received FDA clearance. The MagVenture TMS Therapy System and its technological characteristics remain equivalent to those cleared under K150641, K170114, K171481, K171967, K172667, K173620.

This submission introduces the following modifications:

• Expanded Indications: MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21)
• Coil Approval Expansion: Inclusion of Cool D-B80 for MDD in adolescent patients (age 15-21).
• Beam F3 Marking Method: Introduces the Beam F3 marking plate as an alternative to the standard 5.5 cm method for coil positioning in the dorsolateral prefrontal cortex (DLPFC).

Apart from the modifications outlined above, the core design, fundamental operating principles, and safety characteristics remain substantially equivalent to the previously cleared MagVenture TMS Therapy System.

The provided FDA 510(k) clearance letter and associated summary pertain to the MagVenture TMS Therapy System. However, this documentation does not describe an acceptance criteria table or a study that specifically proves the device meets such criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for the treatment of Major Depressive Disorder (MDD) in adolescent patients, expanding indications, and introducing a new coil positioning method. It highlights non-clinical performance testing against electrical safety and performance standards (e.g., IEC 60601-1) and a clinical literature review to support safety and effectiveness.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML enabled medical device, as the provided text relates to a Transcranial Magnetic Stimulation (TMS) system, which is a hardware-based therapy device, not an AI/ML diagnostic or prognostic tool.

The questions you've asked are highly relevant for the clearance of AI/ML medical devices (e.g., in medical imaging or diagnostics), which require rigorous validation of their algorithmic performance. The provided document does not contain this information because the MagVenture TMS Therapy System is not an AI/ML enabled device.

To answer your request accurately, based on the provided text, I can only state that the document does not contain the information required to populate the fields related to AI/ML device acceptance criteria and validation studies.

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MagVenture TMS Therapy 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 MagVenture TMS Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The MagVenture TMS Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex.

Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp.

The pulses generate an electric field in the underlying brain tissue. When this field surpasses a specific threshold and aligns appropriately with the brain's neuronal pathways, it induces localized axonal depolarization, leading to neuron activation in the targeted brain region.

The MagVenture TMS Therapy System represents an integrated system comprised of the following components:

• Magnetic Stimulator (MagPro Family)
• Coil for motor threshold determination: C-B60, C-B70
• Treatment Coils: Cool-B65, Cool-B70, Cool D-B80
• Accessories:
  • Trolley with mounting for super flexible arm and coil holder arrangement)
  • Patient head fixation
  • Super flexible arm or Flow Arm for coil fixation
  • Isolation transformer
  • Cooler Unit
  • Caps and Marking accessory (marking plate, pen, ruler) – Beam F3 or 5.5 cm Coil Placement
  • Vacuum pump and Vacuum pillow with Pillow Case for patient head fixation (Optional)
  • Treatment Chair (Optional)
  • Coil Hub (Optional)
  • MagVenture TMS Atlas Neuro Navigation System (Optional)

Except for the Beam F3 marking plate, all components have previously received FDA clearance. The MagVenture TMS Therapy System and its technological characteristics remain equivalent to those cleared under K150641, K171481, K171967, K173620, K193006 for Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD) indications.

This submission introduces the following modifications:

• Expanded Indications: Includes treatment for depressive episodes and comorbid anxiety symptoms in adult patients with MDD who have not responded satisfactorily to prior antidepressant medication.
• Coil Approval Expansion: All three MagVenture treatment coils are now included for MDD, MDD w/ comorbid anxiety symptoms, depressive episodes, and OCD treatment.
• Beam F3 Marking Method: Introduces the Beam F3 marking plate as an alternative to the standard 5.5 cm method for coil positioning in the dorsolateral prefrontal cortex (DLPFC).

All other aspects of the device compared to the currently marketed MagVenture TMS Therapy remain unchanged.

The provided FDA 510(k) clearance letter for the MagVenture TMS Therapy System does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially in the context of AI/algorithm performance.

This document is a traditional 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria for a new, AI-driven diagnostic or therapeutic system.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Device Type: The MagVenture TMS Therapy System is a Transcranial Magnetic Stimulation device, an electromechanical medical device that physically delivers magnetic pulses. It is not an AI-driven diagnostic or therapeutic algorithm. The "AI" context in your prompt is not relevant to this specific device.
• Focus of 510(k): The core of this 510(k) summary is to demonstrate that the MagVenture TMS Therapy System, with its introduced modifications, is "substantially equivalent" to an existing predicate device (NeuroStar Advanced Therapy System, K230029). This is shown by comparing technological characteristics, indications for use, and treatment parameters, not by conducting novel clinical trials to establish its own efficacy against predefined acceptance criteria for AI performance.
• "Performance Data" Section (Page 16): This section explicitly states:
  • "No clinical performance data were included in this submission."
  • Performance testing summarized relates to electrical safety, electromagnetic compatibility (compliance with IEC standards), and quality/risk management (ISO standards).
  • Computational modeling (SimNIBS v4.0.1) was used to compare electric field strength of coils, which is a physical characteristic, not a clinical efficacy or AI performance metric.

Therefore, I cannot provide the requested information based on the provided document. The document discusses the device's technical specifications and its equivalence to a predicate device, but not how it meets acceptance criteria for an AI or imaging-based clinical outcome.

Specifically, the following points from your request cannot be addressed as they pertain to AI/algorithm performance studies which are not described in this 510(k):

1. Table of acceptance criteria and reported device performance (for AI performance): Not applicable. The "performance" discussed is electrical and safety compliance, not AI accuracy or efficacy.
2. Sample size for test set and data provenance: No clinical test set data for algorithm performance is mentioned.
3. Number of experts and qualifications for ground truth: No expert-driven ground truth establishment for AI is mentioned.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as there's no AI component or human-in-the-loop study discussed.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of AI/algorithm performance.
8. Sample size for training set: No training set for an algorithm is mentioned.
9. How ground truth for training set was established: Not applicable.

This 510(k) clearance is for a physical medical device, not an AI software.

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Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The MagVenture Coil T65 is a figure-of-eight, actively cooled coil designed for use in transcranial magnetic stimulation (TMS) therapy as part of the MagVenture TMS Therapy System. The system delivers magnetic pulses for generating evoked responses, assessing motor thresholds (MT), and administering therapeutic treatments.

The T65 is a redesign of the treatment coil Cool-B65, to include the motor threshold (MT) determination capability of the C-B60 coil. This reduces the need for coil exchange during patient sessions, supporting a more streamlined workflow for clinicians.

The T65 incorporates several ergonomic and functional enhancements compared to the existing coil:

• Integrated intensity control wheel allowing direct manual adjustment of stimulation output.
• Built-in trigger button with LED status indication to display coil readiness.
• Reduced weight for improved maneuverability and ease of use.
• Strain relief mechanisms at both the coil and connector ends to improve durability and reduce cable stress.

The provided FDA 510(k) clearance letter for the T65 Repetitive Transcranial Magnetic Stimulation System does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

This document is a Special 510(k) submission, which signifies that the device (T65 coil) is a modification of an existing cleared device (Cool-B65 coil) and that the modifications do not raise new questions of safety or effectiveness. The core of such a submission is to demonstrate substantial equivalence to a predicate device.

Specifically, the document states:

• "No clinical testing is required to support this submission." This explicitly indicates that no comparative effectiveness study (like an MRMC study) or standalone performance study was performed or needed.
• The comparison focuses on technological characteristics (weight, integrated intensity control, trigger button, materials, electrical safety, etc.) and states that these differences "does not raise different questions of safety and effectiveness compared to the existing device."
• The non-clinical testing focuses on compliance with general safety and performance standards (IEC 60601-1, IEC 60601-1-2, ISO 13485, ISO 14971) and ensuring magnetic field characteristics are within a ±5% tolerance of the predicate device. This is a performance verification of the physical device components, not an AI or algorithm performance evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert involvement, or AI performance metrics because this information is not present in the provided text. The device is a physical medical device (a TMS coil), not an AI-powered diagnostic or therapeutic algorithm.

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The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Ampa One System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Ampa One System is an integrated system composed of the following hardware and software components with associated functions to enable its intended use:

• Ampa L and M Coils - MT determination and Depression treatment
• Ampa Pulse Generator - Provide Electrical power to the coils
• Ampa Control Pad - The software interface for operators to control TMS treatment
• Axon Cable - Provides connections between the Ampa Pulse Generator and Ampa Control Pad
• Ampa Magic Arm - Support system to securely hold the coils in place during treatment
• Neuronavigation Cap - Fabric cap worn by patient with integrated markings for determination of cerebral cortex treatment targets

The system comes preloaded with a mobile app on the Ampa Control Pad containing the software interface for operation of the system.

This FDA 510(k) clearance letter pertains to a modification of an existing device, the Ampa One System (AMPA-001), specifically replacing a bridging connector and external pulse generator with an integrated Ampa Pulse Generator. The clearance relies on demonstrating substantial equivalence to the previously cleared Ampa One System (K243319).

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a "table of acceptance criteria" with specific quantitative thresholds. Instead, it states that the acceptance criteria are based on demonstrating "substantially equivalent magnetic characteristics compared to the predicate devices" and "equivalent in terms of safety and effectiveness." The reported performance is articulated through comparative testing against the predicate device.

• Amplitude of the magnetic field strength as a function of power input.
• Spatial characteristics of the magnetic field.
• Waveforms (210 μs biphasic sinusoid for both L and M coils with the new system vs. 290 μs with predicate, deemed substantially equivalent) |
  | Safety | The device is able to function as intended, with risks assessed of TMS therapy mitigated through design. | Safety testing established that the Ampa One System (new configuration) is able to function in its configuration with the Ampa One pulse generator to perform its intended use. Development and testing performed in conformance with FDA Special Controls Guidance on Transcranial Magnetic Stimulator devices and voluntary consensus standards (e.g., IEC 60601-1 and IEC 60601-1-2 for electrical safety). |
  | Treatment Protocol Parameters | Identical or substantially equivalent to the predicate device's parameters. | Identical: Repetition rate, pulses per train, number of trains, inter train interval, treatment time, coil configuration, patient contacting materials, coil positioning system.
  Substantially Equivalent: L Coil SMT range (0-1.7 SMT vs 0-2.0 SMT for predicate), M Coil SMT range (0-1.4 SMT vs 0-1.7 SMT for predicate). These differences are considered substantially equivalent. |

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

The document explicitly states: "Clinical Data was not applicable for this submission."
Therefore, there was no clinical test set in the traditional sense, and thus no sample size for clinical efficacy or safety, nor data provenance information for such a test set. The testing conducted was non-clinical (bench testing) to demonstrate substantial equivalence of the modified device's performance to the predicate device.

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)

Since no clinical data or human evaluation of the device's diagnostic or therapeutic outcome was conducted for this 510(k), there were no experts used to establish a "ground truth" in the context of a clinical test set. The validation was based on engineering and performance specifications compared against the predicate device.

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

Not applicable. As per point 3, no clinical test set requiring expert adjudication was utilized for 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 Repetitive Transcranial Magnetic Stimulation System, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not relevant to this 510(k) submission.

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

The "standalone" performance in this context would refer to the performance of the Ampa One System itself, measured through its magnetic characteristics and functional safety. This type of non-clinical, standalone performance testing was indeed done. The effectiveness testing specifically focused on the magnetic characteristics of the Ampa One System with the new pulse generator, comparing them to the predicate device.

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

For this non-clinical submission, the "ground truth" for demonstrating substantial equivalence was effectively the established performance characteristics of the legally marketed predicate device (Ampa One System K243319), as defined by its prior FDA clearance and the relevant FDA Special Controls Guidance. The new device's performance was measured and compared against these established characteristics to prove it met the same reasonable expectation of safety and effectiveness.

8. The sample size for the training set

Not applicable. This 510(k) pertains to a hardware modification of an existing medical device, not a machine learning or AI-driven system that requires a "training set."

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

Not applicable, as there was no training set for this submission.

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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 medications in the current episode.

The Ultimate rTMS 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 prefrontal cortex for the treatment of Major Depressive Disorder.

It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.

The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

Area of the brain to be simulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.

This 510(k) clearance letter details the substantial equivalence of the Ultimate rTMS device to its predicate devices, Mag Vita TMS Therapy System. The provided information primarily focuses on non-clinical performance and technological comparisons, rather than a clinical trial with human subjects. Therefore, some information requested in your prompt regarding clinical study elements (like sample size for test sets, ground truth establishment for test sets, expert adjudication, or MRMC studies) is not explicitly detailed or applicable in the provided document.

Here's the breakdown of the acceptance criteria and the study (non-clinical performance tests) that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table, but rather implied through the "Equivalence Comments" in the "Technological Comparison" and the "Non-clinical and/or Clinical Tests Summary & Conclusions" sections. The core acceptance criterion is substantial equivalence to the predicate devices, meaning the Ultimate rTMS device performs similarly and does not raise new safety or effectiveness concerns.

Here's a table summarizing the key performance metrics and their comparison to predicates, which serve as the "acceptance criteria" through equivalence:

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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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