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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 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 settings, including physicians' offices, clinics, and hospitals.

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

The provided document is a 510(k) Premarket Notification from the FDA for the Magstim®Horizon® 3.0 TMS Therapy System. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

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

Key Takeaway: The device discussed is the Magstim®Horizon® 3.0 TMS Therapy System, and the submission is a 510(k) to demonstrate substantial equivalence to a previously cleared version (K222171). The testing described is primarily non-clinical bench testing focused on changes made to the device's camera tracking system and EMG amplifier, ensuring these changes do not raise new questions of safety or effectiveness and that the performance is equivalent or better than the predicate device. No clinical studies or human reader studies (MRMC) were conducted or mentioned as a requirement for this particular submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on demonstrating performance equivalent to or better than the predicate device, especially for the modified components (camera tracking and EMG). The performance metrics are largely quantitative measurements from bench testing.

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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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The Horizon® 3.0 TMS Therapy System is intended to produce and deliver 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.

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 (MDD) in adult patients who have failed to achieve satisfactory improvement from 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.

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

The provided text describes a 510(k) premarket notification for the Magstim Horizon 3.0 TMS Therapy System, seeking substantial equivalence to existing devices for the treatment of Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD).

However, the document does not contain the results of a study designed to directly prove the device meets specific acceptance criteria based on clinical performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and limited non-clinical testing.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available from the provided text in the way they would be for an AI/ML diagnostic or prognostic device.

Here's an analysis based on the available information:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The device, Magstim Horizon 3.0 TMS Therapy System, is a medical device for therapeutic intervention (Transcranial Magnetic Stimulation), not a diagnostic or prognostic device that typically has performance metrics like sensitivity or specificity. The "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices, focusing on safety and effectiveness.

The "study" referenced for performance is primarily non-clinical testing and reliance on prior FDA clearances and published literature for predicate devices to support the extension of indications for use.

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

Since the device is a therapeutic system and not a diagnostic one, the acceptance criteria are not in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are centered on demonstrating that the proposed changes (primarily for OCD treatment indication) do not raise new questions of safety or effectiveness compared to predicate devices, and that the device can reliably deliver the therapy.

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

• Software Verification & Validation: The sample size for testing specific software functions or modules is not explicitly stated, but it would involve testing different use cases and parameter configurations. The data provenance is internal to the manufacturer's testing processes.
• Performance Verification of Therapeutic Delivery: Not specified as a typical patient "test set." Verification involves testing the device under various operational conditions.
• FEM Modeling: This is a computational simulation, not a physical test set with human subjects.
• Human Factors Testing: The sample size of "representative TMS users" is not explicitly stated. The provenance is likely internal testing data.
• Clinical Efficacy (Retrospective Study): The retrospective open-label study referenced (Oliveira-Maia, Garcia-Guarniz, et al.) is external scientific literature, not a study specifically conducted for this 510(k). The sample size for this study is not provided in the snippet, nor is the country of origin. It is a retrospective study.

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 is not applicable in the context of this 510(k) submission, as it focuses on device safety and functional equivalence for a therapeutic system, not on establishing ground truth for diagnostic classifications by expert consensus. The "ground truth" for the device's function is its ability to reliably and safely deliver magnetic stimulation as intended, which is verified through engineering tests and adherence to standards.

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

Not applicable. This concept is typically used in studies where human readers independently evaluate data and their findings require reconciliation to establish a ground truth. The non-clinical tests and simulations for the TMS system don't involve this type of 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

Not applicable. This device is a therapeutic system, not a diagnostic or AI-assisted interpretation tool where "human readers" would be involved in interpreting cases with or without AI assistance. The retrospective clinical study referenced in the submission is a comparative efficacy study of two different TMS devices, not an MRMC study involving AI assistance for human readers.

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

This concept is not directly applicable. The device itself is a clinical tool used by a human operator (licensed physician). There is no "algorithm only" performance for a therapeutic TMS system. The software and hardware perform specific functions, but the overall therapy involves human-in-the-loop operation.

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

For the non-clinical tests:

• Software V&V: Ground truth is defined by specified software requirements and expected outputs.
• Performance Verification: Ground truth is defined by recognized safety limits and therapeutic delivery specifications (e.g., maximum output, temperature limits) as per international standards.
• FEM Modeling: Ground truth is derived from the physics principles governing electromagnetic fields and computational models, validated against known physical laws and prior successful device models.
• Human Factors: Ground truth relates to user comprehension, ability to perform tasks, and low variability in coil positioning, assessed against defined human factors engineering principles and successful task completion.

For the claim of substantial equivalence for clinical efficacy:

• Prior Equivalency Determination (K143531): FDA's prior determination of substantial equivalence for MDD treatment implies an acceptance of equivalent clinical outcomes based on comparative data.
• Retrospective Open-Label Study: The ground truth for this study would be patient outcomes (e.g., reduction in depression symptoms) as measured by clinical scales, which is a form of outcomes data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a "training phase" on a dataset in the conventional sense. The development of the device follows engineering design, verification, and validation principles.

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

Not applicable, as there is no "training set" in the context of this medical device's development or regulatory submission.

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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.

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 antidepressant medication in the current episode. 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.

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

The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below. It is important to note that this document primarily focuses on non-clinical testing for substantial equivalence to predicate devices, rather than a clinical effectiveness study against a gold standard.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical testing conducted to validate the performance of the Horizon® 3.0 TMS Therapy System and to ensure it meets design specifications and relevant FDA guidance. The "acceptance criteria" here are generally compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" is the outcome of these compliance tests.

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

The document does not specify a "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical bench testing and verification/validation activities on the device itself.

• For tests like Electrical Safety, EMC, and Alarm Systems, a "sample Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+)" was used.
• For Biocompatibility, "samples of these materials" (patient-contacting components) were tested.
• For Human Factors, "Usability testing was performed to Horizon® 3.0 TMS Therapy System."

Data Provenance: This is not applicable to the non-clinical testing described, as it does not involve patient data. The tests were performed by independent test laboratories (BSI Appliances, Eurofins Hursley) and internally by Magstim.

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

This is not applicable as the study involves non-clinical engineering and systems testing, not the establishment of a medical 'ground truth' based on expert consensus for diagnostic or prognostic purposes. Compliance with standards and direct measurement against specifications serve as the "ground truth."

4. Adjudication Method for the Test Set

This is not applicable, as the study does not involve expert adjudication of medical cases. The tests are objective measurements and compliance checks performed by qualified testing laboratories and the manufacturer.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states that the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical trial of effectiveness. There is no mention of human readers or AI assistance in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physical medical system (Transcranial Magnetic Stimulation Therapy System), not primarily an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the typical sense of AI diagnostics. However, the software components of the device were a subject of extensive verification and validation testing, including assessing cybersecurity risks, as part of the overall system. This can be seen as an evaluation of the system's inherent performance, albeit for a complex electro-mechanical system rather than a purely diagnostic algorithm.

7. The Type of Ground Truth Used

For this submission, the "ground truth" for the non-clinical testing is:

• Recognized International and National Standards: e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 10993 series, AAMI/ANSI HE75, IEC 62366-1.
• Design Specifications and Intended Performance: The device was tested to ensure it performs as intended and meets its internal design specifications.
• FDA Guidance: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."
• Predicate Device Characteristics: Comparison of the new device's technical specifications and performance to legally marketed predicate devices to establish substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. The document describes a 510(k) submission based on non-clinical testing for substantial equivalence. It does not involve machine learning models that require training sets of data.

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

This is not applicable, as no machine learning training set is described in the document.

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The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.

Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.

Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.

The Neurosign® V4 Intraoperative Nerve Monitor (IONM) is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery. The subject device differs from its primary predicate due to the introduction of improved Pre-amplifier and Stimulator pod cables, as well the addition of an 8-channel Pre-amplifier variant.

Using needle or surface electrodes connected to the Pre-amplifier, the nerve monitor detects electromyographic (EMG) signals within muscles caused by the contraction of the muscle due to mechanical manipulation or electrical stimulation of the nerve controlling it. The Neurosign® V4 then amplifies the EMG data into an audible signal and displays the data as a waveform on the active monitoring screen.

The Neurosign® V4 Intraoperative Nerve Monitor is used for patient treatment by prescription only under the supervision of a licensed physician.

The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories.

The provided document is a 510(k) Premarket Notification from the FDA for the Neurosign® V4 Intraoperative Nerve Monitor. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically a study that establishes performance against discrete clinical acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain a study with acceptance criteria and reported device performance in the typical sense of a clinical trial for a novel device. Instead, the "acceptance criteria" are compliance with various recognized standards and the "study" is non-clinical bench testing to demonstrate that modifications to an existing predicate device do not alter its safety or effectiveness.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes used for the Test Set and Data Provenance

This submission is based on non-clinical bench testing and does not involve human subjects as a "test set" in the sense of a clinical study.

• Electrical Safety, EMC, Alarm Systems, Biocompatibility: "A sample Neurosign® V4 (4-Channel and 8-Channel Variants)" or "A sample Neurosign® V4 (4-Channel)" or "Samples of these materials" were tested. The exact number of units/samples is not specified beyond "a sample" or "samples."
• Human Factors Testing: Not specified, but "Usability testing was performed to analyze the user experience of the 8-Channel Neurosign® V4." This typically involves a small group of representative users, but the size is not disclosed.
• Data Provenance: All testing appears to be retrospective relative to the design changes, commissioned by Magstim Company Ltd. and conducted by either Magstim or independent test laboratories (Element Materials Technology, Eurofins Hursley). The country of origin for the tests is not explicitly stated for all labs, but Magstim is a UK company.

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

This type of submission does not involve "ground truth" established by clinical experts in the context of diagnostic accuracy or treatment effectiveness. The "ground truth" here is compliance with recognized engineering and safety standards, as verified by independent test laboratories and Magstim's internal testing. The qualifications would be expertise in those specific standards and testing protocols, which are inherent to the testing bodies but not explicitly detailed for individual experts in this document.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of clinical outcomes. The "adjudication" is essentially the determination of compliance with the specified standards by the testing bodies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe a MRMC comparative effectiveness study. The device is an intraoperative nerve monitor, and the study focuses on its safety and performance based on engineering and safety standards, and its substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a way. The testing described (electrical safety, EMC, alarm systems, biocompatibility, and software V&V) assesses the device's technical performance and safety characteristics in isolation, or as an integrated system, without necessarily involving a human-in-the-loop performance assessment of its diagnostic or treatment guidance capability in a clinical setting beyond usability testing for user experience. The "performance" mentioned for cables is also standalone bench testing.

7. Type of Ground Truth Used

The ground truth used in this context is:

• Compliance with recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series for biocompatibility, AAMI/ANSI HE75, IEC 62366-1 for human factors).
• Performance specifications (e.g., isolation parameters, EMC performance, software functions) as tested against predefined engineering requirements.
• Usability metrics defined in the human factors engineering report.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. It is a hardware medical device with embedded software. The software underwent verification and validation, but this refers to traditional software testing, not AI model training.

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

Not applicable, as there is no AI/ML training set in this context.

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HORIZON® 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 HORIZON® TMS Therapy System with Navigation (HORIZON®) 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.

HORIZON® is an integrated system consisting of a combination of hardware, software, and accessories.

The provided document focuses on the 510(k) summary for the Magstim HORIZON® TMS Therapy System with Navigation (K183376). This submission is for a medical device (Transcranial Magnetic Stimulation System) for the treatment of Major Depressive Disorder. The document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm's performance, as the device is not described as an AI/ML product.

The document details the device's substantial equivalence to predicate devices based on technological characteristics, intended use, and non-clinical testing (electrical safety, EMC, biocompatibility, and software verification/validation). It does not describe performance metrics related to diagnostic accuracy, sensitivity, specificity, or other typical AI/ML acceptance criteria.

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and performance study details for an AI/ML device from the provided text. The device described is a hardware-based system with associated software, not an AI/ML algorithm.

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The HORIZON® 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.

The HORIZON® 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.

The HORIZON® 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 antidepressant medication in the current episode. The HORIZON® 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® TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.

This document describes the Magstim HORIZON® TMS Therapy System, specifically focusing on K182853, which adds a new treatment protocol (iTBS) to a previously cleared device (K180907). The document demonstrates substantial equivalence to predicate devices, rather than presenting a de novo study with acceptance criteria and performance data for a novel device. Therefore, many of the requested sections (sample size, expert ground truth, adjudication, MRMC) are not applicable as they relate to clinical studies proving efficacy or diagnostic performance, which were not performed for this submission.

However, I can extract information related to the device's technical specifications and the basis for its safety and effectiveness claims.

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission for adding a treatment protocol, there aren't traditional "acceptance criteria" for performance that a new device would need to meet in a clinical trial. Instead, the acceptance criteria here are demonstrating that the addition of the iTBS protocol poses no new issues of safety or effectiveness, and that the device remains substantially equivalent to already cleared devices.

Table of "Acceptance Criteria" (demonstrated equivalency) and Reported Device "Performance" (characteristics for comparison):

Study Details (Not Applicable for this Submission Type):

As this is a 510(k) submission based on substantial equivalence for a minor modification (adding a treatment protocol) to an already cleared device, detailed clinical studies with the specific elements requested (sample sizes, expert ground truth, adjudication methods, MRMC studies) were not performed or required for this particular submission. The "study" here is primarily a comparative analysis to existing cleared devices and verification of the technical aspects of the new protocol addition.

1. Sample size used for the test set and the data provenance: Not applicable. No new clinical test set was used for this 510(k) submission. The data provenance is implied by the predicate devices being legally marketed in the US.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical efficacy was established by the predicate devices' historical data or studies, not new data for this submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 is not an AI/diagnostic imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the original clearance of the predicate devices, clinical efficacy would have been established through clinical trials and outcomes data. For this specific submission, the ground truth for safety and effectiveness of the iTBS protocol is implicitly based on its successful clearance and clinical use in the primary predicate device (Mag Vita TMS Therapy System w/Theta Burst Stimulation, K173620) and the physical and electrical equivalence of the HORIZON system to its prior clearance (K180907).
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense.
8. How the ground truth for the training set was established: Not applicable.

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The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.

Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.

Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.

The Neurosign® V4 Intraoperative Nerve Monitor is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery.

Using needle or surface electrodes connected to the Pre-Amplifier Pod, the nerve monitor detects electromyographic (EMG) signals within muscles caused by the contraction of the muscle due to mechanical manipulation or electrical stimulation of the nerve controlling it. The Neurosign® V4 then amplifies the EMG data into an audible signal and displays the data as a waveform on the active monitoring screen.

The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories.

The Neurosian® V4 is comprised of following four components:

1. Neurosign® V4 Intraoperative Nerve Monitor
2. Neurosign® V4 Pre-Amplifier Pod 4 Channel
3. Neurosign® V4 Stimulator Pod
4. Neurosign® V4 Mute Sensor

The Neurosign® V4 Intraoperative Nerve Monitor (IONM) includes a user interface comprised of an audio output, a color graphics display with a touch screen and dedicated rotary controls for frequently adjusted parameters.

EMG signals are collected from the patient using needle and surface electrodes. The Neurosign® V4 Pre-Amplifier Pod collects, processes and transmits the EMG signals to the IONM for display and for an audio output.

The Neurosign® V4 Stimulator Pod allows the simultaneous connection of two stimulating probes for the mapping and locating of nerves within tissue, and to test the nerve activity at various stages during surgery.

The provided text describes the regulatory clearance of the Neurosign® V4 Intraoperative Nerve Monitor, primarily through demonstrating substantial equivalence to predicate devices, rather than an AI-driven device requiring extensive ground truth establishment and MRMC studies.

Therefore, many of the requested elements for an AI/ML-driven device evaluation, such as sample sizes for training/test sets, expert qualifications for ground truth, adjudication methods, and MRMC study details, are not applicable or detailed in this document. The document focuses on demonstrating that the new device performs similarly and is as safe and effective as existing legally marketed predicate devices through non-clinical testing and comparisons of technological characteristics.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets those criteria based on the provided text, primarily under the "Non-Clinical Testing" section.

Acceptance Criteria and Device Performance Study for Neurosign® V4 Intraoperative Nerve Monitor

This submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for an AI/ML algorithm. The "acceptance criteria" are implied by compliance with recognized standards and performance parity with predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Testing: The document refers to "A sample Neurosign® V4" being tested for electrical safety, EMC, and alarm systems. For biocompatibility, "Samples of these materials" were tested. For amplifier and stimulator equivalence, the testing was done by comparing the Neurosign® V4 directly against the predicate device (NIM-Response 3.0) using function generators and oscilloscopes, not patient data. Therefore, the "sample size" is effectively one device model, and samples of materials/components, tested under controlled laboratory conditions against various standard requirements.
• Data Provenance: This is a non-clinical, laboratory-based study. The data is generated from controlled tests of the device's hardware and software components against international standards and in direct comparison with a predicate device. There is no mention of human (patient) data or geographical origin of such data. This is retrospective in the sense that it evaluates the manufactured device against pre-defined performance and safety standards.

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

• N/A. This submission does not involve clinical data or deep learning models requiring "ground truth" established by human experts in the typical sense of AI/ML device evaluations. The ground truth for the non-clinical tests is based on the specifications of the standards (e.g., IEC 60601-1) and the measured performance of the predicate device. The testing was performed by "independent test laboratories" (e.g., Element Materials Technology, Kiwa Blackwood Compliance Laboratories, Harlan Laboratories Ltd, Envigo Research Ltd), implying their expertise in medical device testing and regulatory compliance.

4. Adjudication Method for the Test Set

• N/A. Since there's no qualitative assessment of clinical data by multiple readers, an adjudication method is not applicable. The tests are quantitative measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study was not conducted as this device is not an AI/ML diagnostic aid intended to improve human reader performance on medical images. It is an intraoperative nerve monitor, and its safety and effectiveness were demonstrated through engineering (non-clinical) tests and substantial equivalence.

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

• Yes, in spirit. The performance evaluation for the amplifier and stimulator equivalence was a "standalone" evaluation of the device's electrical characteristics. The software verification and validation are also a standalone assessment of the device's algorithmic performance. However, this is not an "algorithm only" study in the context of an AI/ML diagnostic device, but rather the performance of an integrated hardware and software system.

7. The Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance: The "ground truth" used for testing was primarily:
  • Compliance with specific international standards (e.g., IEC 60601-1, EN 60601-1-2, IEC 60601-1-8, ISO 10993 series).
  • The measured electrical output and signal processing characteristics of the legally marketed predicate device (NIM-Response 3.0). The acceptance criteria for the Neurosign® V4's performance were defined as being "within 5% of the target input and ±1% of each other" when compared to the predicate for EMG acquisition, and "almost identical" for stimulator performance.

8. The Sample Size for the Training Set

• N/A. This device does not employ a machine learning model that requires a training set in the typical sense. Its functionality is based on established electrophysiology principles and pre-programmed algorithms, not data-driven learning.

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

• N/A. As no training set was used, this question is not applicable.

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The HORIZON™ 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.

The HORIZON® 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. The HORIZON® 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 antidepressant medication in the current episode. The HORIZON® 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.

This document is a 510(k) premarket notification from the FDA, approving the Magstim HORIZON™ TMS Therapy System. It states that the device is substantially equivalent to a predicate device and therefore does not contain all the detailed information typically found in a full clinical study report. Specifically, it focuses on non-clinical testing for substantial equivalence rather than a comparative clinical effectiveness study (MRMC) or standalone algorithm performance.

However, based on the provided text, we can extract details about the acceptance criteria (implicitly defined by the substantial equivalence argument), the study proving it meets these, and some related information:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document doesn't present explicit quantitative acceptance criteria as one might find for a novel device, but rather frames "acceptance" as demonstration of substantial equivalence to a previously cleared predicate device. The performance is assessed by comparing technical characteristics.

   Criteria	HORIZON® TMS Therapy System (Subject Device)	HORIZON® Therapy System (K171051) (Primary Predicate)	NeuroStar TMS Therapy System (K160703) (Secondary Predicate)	Neurosoft TMS (K173441) (Secondary Predicate)
   Intended Use/Indications for Use	Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.	Identical	Identical	Identical
   Sessions/week	5	5	5	5
   Treatment Schedule	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks
   Area of brain to be stimulated	Left Dorsolateral Prefrontal Cortex	Left Dorsolateral Prefrontal Cortex	Left Dorsolateral Prefrontal Cortex	Left Dorsolateral Prefrontal Cortex
   Waveform	Biphasic	Biphasic	Biphasic	Biphasic
   Core Material	Air	Air	Ferromagnetic core	Air
   Pulse Width	330μs (range given as 0.28-1.9)	340μs (range given as 0.28-1.9)	300μs	185μs
   Magnetic Field Intensity	120% of the MT	120% of the MT	120% of the MT	120% of the MT
   Stimulus Frequency	10 Hz	10 Hz	10 Hz	10 Hz
   Stimulus Train duration	4 sec	4 sec	4 sec	4 sec
   Inter-train interval	11-26 sec	26 sec	11-26 sec	11-26 sec
   Number of trains	75	75	75	75
   Magnetic Pulses per Session	3000	3000	3000	3000
   Treatment Session Duration	18.8 min-37.5 min	37.5 min	18.8 min – 37.5 min	18.8 min-37.5 min
   Maximum # of pulses per session (cumulative exposure)	60,000	6,000	5,000	72,000 (stand-alone), 240,000 (with PC)
   Maximum output amplitude (V/m) at 2cm	150 V/m	150 V/m	135V/m nominal	Not disclosed by Manufacturer
   Electrical Safety Standards	IEC 60601-1 (Ed. 3.1.)	IEC 60601-1	Not explicitly stated for predicate in table, but general statement of meeting standards applies.	Not explicitly stated for predicate in table, but general statement of meeting standards applies.
   EMC Standards	EN 60601-1-2 (2007)	EN 60601-1-2	Not explicitly stated for predicate in table.	Not explicitly stated for predicate in table.

   Note: Bolded values highlight the parameters where the subject device differs from its primary predicate but aligns with secondary predicates, demonstrating substantial equivalence through a combination of existing cleared devices.

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

   The document does not describe a test set in the context of a clinical trial with human subjects for performance evaluation like an AI/algorithm-based diagnostic device would. This is a premarket notification for a medical device (TMS system) based on substantial equivalence to predicates.

   The "testing" mentioned is primarily non-clinical:

   • Electrical safety and electromagnetic compatibility (EMC) testing: Done on the system itself to demonstrate compliance with standards (IEC 60601-1, EN 60601-1-2).
   • Biocompatibility evaluation: Demonstrated adherence to ISO 10993-1.
   • Acoustic output measurements: Conducted during IEC 60601-1 testing.
   • Software verification and validation testing: To ensure software performs as intended.
   • Magnetic field characteristics testing: To show substantial equivalence to the primary predicate.

   There's no mention of a "test set" of patient data or clinical retrospective/prospective studies demonstrating diagnostic or treatment efficacy in the context of an algorithm's performance on patient data. This is a physical therapy device, not a diagnostic AI.

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

   Not applicable. No clinical "test set" with ground truth established by experts is described in this 510(k) summary for a TMS therapy system.

4. Adjudication method for the test set:

   Not applicable. See 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:

   Not applicable. The device is a Transcranial Magnetic Stimulation (TMS) system for treating Major Depressive Disorder. It is not an AI diagnostic tool designed to assist human readers (e.g., radiologists) in interpreting data.

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

   Not applicable in the context of diagnostic AI. This is a therapeutic device. The "standalone" mention in the table under Neurosoft TMS refers to its ability to deliver pulses independent of a PC connection, not an algorithm's diagnostic performance.

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

   Not applicable for a clinical test set. The "ground truth" for the non-clinical testing relates to engineering and safety standards (e.g., whether the device output is within specified ranges, whether it meets electrical safety requirements).

8. The sample size for the training set:

   Not applicable. No machine learning training set is mentioned or relevant for this type of device submission.

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

   Not applicable. No machine learning training set is mentioned.

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

This document is a 510(k) Pre-market Notification for the Magstim HORIZON™ Therapy System, a medical device used for the treatment of Major Depressive Disorder. The core of the submission is to demonstrate the substantial equivalence of the HORIZON™ system to a legally marketed predicate device, the Magstim Rapid² Therapy System.

Therefore, the "acceptance criteria" and "device performance" in this context are evaluated against the predicate device's performance and established safety standards, rather than generating new clinical efficacy data for the new device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the acceptance criteria are largely defined by equivalence to the predicate device and compliance with relevant safety and performance standards. No novel acceptance criteria for clinical effectiveness are presented for the HORIZON™ system itself.

• Identical Stimulus Frequency (10 Hz), Stimulus Train duration (4 sec), Inter-train interval (26 sec), Number of trains (75), Magnetic Pulses per Session (3000), Treatment Session Duration (37.5 min), Sessions/week (5), and Treatment Schedule (5 daily sessions for 6 weeks).
• Same brain area stimulated (Left Dorsolateral Prefrontal Cortex).
• Similar Stimulator Output Parameters (Amplitude, Frequency range, Pulse train duration, Inter-train interval, Max trains per session, Max pulses per session, MT Determination Method, Placement for stimulation).
• Minor modifications: increased thermal performance/reliability of mainframe/power supply, new coil-to-mainframe connector for reliability/usability. |
  | Magnetic Field Characteristics | Identical to predicate device (Air Film Coil and D70mm MT Remote Coil cleared under K143531 and K162935) due to identical coil head geometry. Therefore, equivalent safety and performance is assured (no new testing needed for magnetic field characteristics). Values for Max output amplitude, Max magnetic field strength (at surface and 2cm depth), Max magnetic field gradient (at surface and 2cm depth), and Magnetic field strength gradient ratio are identical to predicate. |
  | Basic Software Capabilities | Same as the predicate device related to treatment administration. |
  | Safety and Performance Standards Compliance | |
  | Electrical Safety | Compliant with IEC 60601-1 (Ed. 3.1.). |
  | Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 (2007). |
  | Biocompatibility | Both coils meet ISO 10993-1 (2009) standards. |
  | Acoustic Output Measurements | Conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance. |
  | Software Verification and Validation | Performed, demonstrating that the software performs as intended and in accordance with specifications. "Moderate" level of concern. |
  | Risk Management | Potential risks identified and evaluated in compliance with ISO14971; risks determined acceptable or addressed with control measures. |

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

The document does not report any clinical test set data from human patients for efficacy or performance of the HORIZON™ Therapy System itself. The submission relies on non-clinical testing and substantial equivalence to the predicate device.

For non-clinical testing:

• Electrical safety and EMC testing: Conducted on "the system" (singular, implies one system tested).
• Biocompatibility evaluation: On "both coils."
• Acoustic output measurements: Conducted during IEC 60601-1 testing.
• Software verification and validation testing: Conducted for the software.

Data provenance: Not applicable in the context of clinical studies. The non-clinical testing was performed for the HORIZON™ device.

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

Not applicable. No clinical ground truth or expert evaluation of clinical outcomes for the HORIZON™ Therapy System is mentioned in this document as part of the substantial equivalence submission. The ground truth for the equivalence claim is based on engineering specifications, compliance with standards, and comparison to the predicate device's design.

4. Adjudication method for the test set

Not applicable. As no clinical test set for independent evaluation of the HORIZON™ device is presented.

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 (TMS) system for treating depression, not an AI diagnostic imaging device. Therefore, MRMC studies are not relevant to this submission.

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

Not applicable. This is a hardware medical device with integrated software, not an AI algorithm. Its performance is inherent to its operation, not a separate "algorithm only" evaluation. The software functionality is verified and validated, but this is distinct from standalone AI performance.

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

For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence are:

• Predicate Device Specifications and Performance: The established, cleared characteristics and performance of the Magstim Rapid² Therapy System serve as the primary ground truth for the comparison.
• International Standards and Regulations: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, and ISO14971 provide the "ground truth" for safety, EMC, biocompatibility, and risk management compliance.
• Engineering Specifications: The design parameters, such as coil winding parameters, inductance, pulse width, and physical dimensions, are considered the ground truth for comparing the technological characteristics to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires training data for its core functionality. The "software" in question refers to control software, not an adaptive learning algorithm.

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

Not applicable, as there is no training set for an AI algorithm. The ground truth for the correctness of the control software (functional specifications) would have been established during software development requirements gathering and design phases.

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