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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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The Ultimate rTMS for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder(OCD).

The Ultimate rTMS for OCD 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 Obsessive-Compulsive Disorder (OCD).

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 ODC treatment is the Dorsomedial Prefrontal Cortex.

The provided FDA 510(k) clearance letter and summary for the "Ultimate rTMS for OCD (M-series)" device focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance characteristics, rather than a clinical study evaluating the device's efficacy in treating OCD. Therefore, it does not contain the detailed information about clinical acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth for test/training sets) that would typically be found in a clinical trial report.

The document primarily shows that the new device's technical specifications and physical/magnetic properties are comparable to a previously cleared device. It asserts that the proposed device does not introduce new safety concerns and has equivalent performance characteristics based on bench testing.

Here's an attempt to answer the questions based on the provided text, with many fields marked as "Not Applicable" or "Not Provided" due to the nature of the submission:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device (MagVenture TMS Therapy system K193006) through close matching of technological characteristics and non-clinical performance (bench testing) according to FDA guidance. The "reported device performance" are the measured values for the Ultimate rTMS for OCD (M-series) in comparison to the predicate.

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

• Sample size: Not applicable. The submission is based on non-clinical (bench) testing of the device's physical and magnetic characteristics rather than a clinical test set of patients.
• Data provenance: Not applicable. The data arises from engineering measurements and comparative bench testing of the physical device components (coils, stimulator output).

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

• Number of experts: Not applicable. Ground truth for clinical efficacy or diagnosis using patient data is not established in this non-clinical submission.
• Qualifications of experts: Not applicable. Engineering and technical experts would have conducted and verified the bench tests.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This was a non-clinical (bench) testing comparison, not a clinical study requiring adjudication of patient outcomes or diagnoses.

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

• MRMC study: No. This is not an AI-assisted diagnostic or therapeutic device that involves human "readers" or image interpretation. It is a TMS system for direct treatment.

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

• Standalone performance: Not applicable. This is a medical device, not a software algorithm in the context of interpretation. Its "standalone" performance is assessed by its physical and magnetic output characteristics in bench tests.

7. The type of ground truth used

• Type of ground truth: The "ground truth" in this context is the measured physical and electromagnetic properties of the new Ultimate rTMS device compared to the established properties of the predicate MagVenture TMS Therapy system, as well as adherence to recognized safety standards (IEC, ISO). The substantial equivalence is built upon the premise that if the new device behaves physically like the predicate, and the predicate is known to be safe and effective, then the new device is also considered safe and effective for the stated indications.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is a conventional medical device whose performance is characterized by its engineering specifications and bench test results. It does not involve machine learning or AI that requires a "training set."

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

• Ground truth for training set: Not applicable (as above).

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

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

The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. ("TMS").

The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of

• Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode
• as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
• as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15--21)

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

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

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

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

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

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

All configurations are composed from the following main components:

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

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

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

8. The Sample Size for the Training Set

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

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

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

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

The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. ("TMS").

The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

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

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

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

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

All configurations are composed from the following main components:

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The BTL-99-OC is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex. BTL-99-OC consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information quides the Operator through the entire therapy procedure. The therapeutic parameters are set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device functions with: M1 figure-of-8 coil applicator. The therapy is provided with the applicator attached to the applicator arm. The BTL-99-OC composed of stimulation generator and stimulation coil. The stimulation generator is driven by software, which the operator controls through the GUI and contains a high voltage energy storage capacitor charging and discharging system, a power supply and a microcomputer control system. The software capabilities for administering treatment in the subject device are the comparable to these in the predicate devices. The stimulation coil is composed of a stimulation coil, an air forced cooling system and an applicator holder. The main unit BTL-99-OC with the M1 coil is intended to be used for both - MT threshold estimation and subsequent application of OCD therapy.

The provided text is a 510(k) summary for the BTL-99-OC device, which is a transcranial magnetic stimulation (TMS) system intended as an adjunct treatment for Obsessive-Compulsive Disorder (OCD). The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MagVenture TMS Therapy system - K193006) and a reference device (BTL-995-rTMS - K212723), rather than presenting a performance study with specific acceptance criteria and detailed findings from a clinical trial.

Therefore, the document does NOT contain the information needed to fill out a table of acceptance criteria and reported device performance based on clinical study outcomes, nor does it detail a study structure that includes sample sizes for test sets, data provenance, expert consultation for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text mostly describes:

• The device's intended use and technical characteristics.
• Comparisons of the BTL-99-OC with its predicate and reference devices, primarily focusing on physical and electrical parameters (e.g., magnetic field intensity, coil parameters, electrical safety compliance) to establish technical substantial equivalence.
• Compliance with electrical safety, software lifecycle, and risk management standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971).
• Bench testing results comparing induced fields in a phantom head, showing values are substantially equivalent within a certain range.

In summary, there is no information in the provided document about a clinical study that proves the device meets specific acceptance criteria related to its clinical efficacy or performance in diagnosing/treating OCD. The substantial equivalence is argued based on technological similarities and adherence to safety standards.

Therefore, I cannot populate the requested table or describe the study details as they are not present in this 510(k) summary.

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The CloudTMS Edge for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The CloudTMS Edge for OCD 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 Obsessive-Compulsive Disorder (OCD).
It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions.General functionalities provided by the system are: - Single pulse stimulation (motor threshold detecting)

• Repetitive stimulation (therapy)
• Patient's data entering
• Stimulation algorithm editing
• Review of stimulation history
• Treatment report generation and printing
• Operation with list of treatment (selection for review, removal, etc.).
  The CloudTMS Edge for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coll; the pulsed magnetic field generated by the discharge current (up to 10 kA) penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons.

This document describes K233742, CloudTMS Edge for OCD, a transcranial magnetic stimulation (rTMS) system intended as an adjunct treatment for adult patients with Obsessive-Compulsive Disorder (OCD).

Based on the provided text, there is no clinical study that explicitly defines acceptance criteria and then presents device performance against those criteria in a table. The submission relies heavily on a comparison with a predicate device (CloudTMS for OCD, K221129) and asserts substantial equivalence based on technological and operational similarities, and non-clinical testing.

Here's an attempt to extract and synthesize the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, a formal table of acceptance criteria and device performance from a clinical study is not provided in this document. The document focuses on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical testing.

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

Since no clinical study comparing the device to acceptance criteria is described, there is no information on the sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The document primarily discusses non-clinical testing for safety and electromagnetic compatibility.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as no clinical study with a ground truth established by experts is described for this device in the provided text.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical study requiring an adjudication method is described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or performed according to the provided text. The document focuses on the device itself and its equivalence to a predicate, not on how human readers might improve with or without AI assistance.

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

A standalone performance study of an algorithm was not described or performed in the provided text. The device is a physical rTMS system, not an AI algorithm requiring standalone performance evaluation in the usual sense.

7. Type of Ground Truth Used

No ground truth (expert consensus, pathology, outcomes data, etc.) was established or used for the CloudTMS Edge for OCD in the context of a clinical performance study as described in this document. The document relies on predicate device equivalence and non-clinical testing for safety and electrical characteristics.

8. Sample Size for the Training Set

This information is not applicable. The device is an rTMS system that produces magnetic fields, not an AI algorithm that would require a training set.

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

This information is not applicable as there is no training set mentioned for this device.

Summary of Device Evaluation in the Document:

The evaluation of the CloudTMS Edge for OCD, as presented in this 510(k) summary, is based on demonstrating substantial equivalence to its predicate device, CloudTMS for OCD (K221129). The key points of the evaluation are:

• Identical Indications for Use: The subject device has the exact same indications for use as the predicate.
• Technological Comparison: The design, operational characteristics, and technological characteristics are nearly identical, with minor modifications.
  • Both systems are rTMS systems, produce non-invasive, repetitive pulsed magnetic fields to induce neural action potentials in the prefrontal cortex for OCD treatment.
  • Both use the same mechanism of action, coil (DCC-03-125-C), and software.
  • Operational procedures, including system setups, motor threshold determination, coil positioning, and treatment stimulation parameters, are identical.
  • Minor modifications in the subject device: automatic voltage detection (110V/220V), upgraded power supply for faster charging, obsolescence replacement for cooled coil connections, and improved graphical user interface. These modifications are asserted to have no known impact on safety or efficacy.
• Non-Clinical Performance Characteristics:
  • Electrical/mechanical/thermal safety and electromagnetic compatibility were verified through testing against IEC 60601-1:2005/(R)2012 and IEC 60601-1-2:2014. (These standards implicitly define some acceptance criteria for these aspects).
  • Biocompatibility characteristics are identical to the predicate because the same patient caps are used.
  • Characteristics of electric and magnetic fields are identical to the predicate (due to the same double cone coil and treatment parameters), including linearity of output, biphasic sinusoidal waveform, pulse width and intensity, magnetic field spatial distribution, and magnetic field strength gradient.
• Conclusion: The device "does not introduce any new safety or effectiveness considerations" compared to the predicate, and all modifications are minor and have no known impact on safety or efficacy.

In essence, the "study" proving the device meets acceptance criteria is a comparison to a legally marketed predicate device, supplemented by non-clinical testing to recognized safety and performance standards for medical devices (IEC 60601 series). No new clinical performance data for efficacy was presented, as the submission relies on the established efficacy of the predicate device.

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The NeuroStar Advanced 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 failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

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

The NeuroStar Advanced 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 induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:

• Mobile Console
• System Software
• Treatment Chair
• Ferromagnetic Treatment Coil
• Head Support System or Headrest
• SenStar® Connect Treatment Link & SenStar® Treatment Link
• Treatment Pack (for use with the SenStar® Connect Treatment Link)
• MDD MT Cap and OCD MT Cap
• TrakStar™ Patient Data Management System
• D-Tect™ MT Accessory
• NeuroSITE

The provided document is a 510(k) summary for the NeuroStar Advanced Therapy System (Version 3.8). This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing clinical study results or acceptance criteria in the comprehensive manner typically found in a clinical study report for an AI/ML device.

However, based on the information provided, we can infer some details relevant to your request, specifically concerning the engineering and human factors testing which serves as the "study" proving the device meets performance criteria, even if not phrased as traditional "acceptance criteria" for an AI/ML algorithm's clinical performance.

Here's an attempt to answer your questions based on the available text:

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

The document does not explicitly state quantitative acceptance criteria for the performance of the new software features, nor does it present device performance in a table with specific metrics. Instead, it states a qualitative conclusion:

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 mentions "verification and validation testing" and "Engineering and Human Factors testing." It does not specify the sample size (e.g., number of uses, number of subjects for human factors) used for these tests. It also does not provide details on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full test reports, which are summarized in the 510(k).

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)

The document does not provide information on the number or qualifications of experts used to establish "ground truth" for the engineering and human factors testing. Given the nature of the change (replacement of physical components for coil positioning), the ground truth for "treatment location equivalence" would likely be based on physical measurements and possibly user observations in human factors studies, rather than expert interpretation of medical images.

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

The document does not describe any adjudication method. This type of process is common in image interpretation studies or clinical trials where subjective assessments are made by multiple readers. For engineering and human factors testing of device mechanics and software functionality, adjudication in this sense is typically not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or mentioned. This submission is for a modification to a Transcranial Magnetic Stimulation (TMS) system, specifically regarding mechanical components and software for coil positioning, not an AI-assisted diagnostic or interpretative device that would typically undergo an MRMC study. The device itself is a treatment device, not primarily an AI-driven interpretive one in the context of MRMC studies.

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

The document does not detail separate standalone algorithm performance. The software change (version 3.8) is explicitly linked to the physical components (NeuroSITE and Headrest) for recording, saving, and displaying patient MT and treatment locations. The testing confirmed the system's ability (software with new hardware) to achieve equivalence, implying an integrated performance evaluation rather than a standalone algorithm assessment.

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

The document doesn't explicitly state the "type of ground truth." However, based on the context of the device modification (coil positioning), the ground truth for "treatment location equivalence" would most likely be established through:

• Engineering measurements: Precise physical measurements of coil placement relative to anatomical landmarks.
• Human factors evaluation: Observation and measurement of user interaction and accuracy in achieving desired coil positions by operators, potentially against a pre-defined target or the performance of the predicate system.
• Absence of new risks: The document emphasizes that the change "does not introduce any new risks" and that "clinical outcomes will be the same," implying that the ground truth for safety and effectiveness is tied to maintaining the established performance of the predicate device.

8. The sample size for the training set

The document does not mention a training set, as this submission is for a hardware and software update to an existing device, not the development or retraining of a new AI/ML algorithm where large training datasets are typically disclosed. The software updates are likely based on engineering design and software development best practices, rather than AI model training.

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

As no training set is mentioned in the context of AI/ML, this question is not applicable to the information provided. The "ground truth" for the software's functionality would have been established through software requirements, design specifications, and subsequent verification and validation testing against these pre-defined expectations.

Summary of what the document focuses on regarding "proof":

The core of the "proof" in this 510(k) submission, regarding the software and hardware changes, is the demonstration through non-clinical testing (engineering and human factors) that the new components perform equivalently to the existing ones in terms of their intended functions, specifically "recording, saving, and displaying the patient's MT and treatment locations" and achieving "treatment location equivalence." The conclusion is that these changes do not introduce new questions of safety or effectiveness. This is a common approach for minor device modifications where clinical performance has already been established by the predicate device.

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

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical 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 induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:

• Mobile Console
• System Software
• Treatment Chair
• Ferromagnetic Treatment Coil
• Head Support System
• SenStar® Connect Treatment Link & SenStar® Treatment Link
• Treatment Pack (for use with the SenStar® Connect Treatment Link)
• MT Cap
• TrakStar™ Patient Data Management System
• D-Tect™ MT Accessory
• Beam F3 Treatment Pack
• OCD MT Cap

The provided text describes the OCD MT Cap, a single-use wearable device intended to be used as an optional aid during the Obsessive-Compulsive Disorder (OCD) Motor Threshold (MT) determination process for the NeuroStar Advanced Therapy System.

However, the document specifies that no clinical testing was required to support this submission, as the proposed change (addition of the OCD MT Cap) is considered to not raise any different questions regarding safety or effectiveness compared to the predicate device. Therefore, a study proving the device meets specific performance acceptance criteria for diagnostic performance is not detailed in this document.

Instead, the document focuses on non-clinical testing and a technological comparison to establish substantial equivalence to a predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical performance study was conducted to establish diagnostic accuracy metrics, a table showing acceptance criteria for such metrics cannot be provided. The reported "performance" is primarily related to compliance with recognized standards and usability.

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

• Not applicable. The document explicitly states: "There is no clinical testing required to support this submission." The testing described is non-clinical (biocompatibility, usability) and a technological comparison.

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 requiring expert ground truth was used.

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

• Not applicable. No clinical test set requiring adjudication was used.

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 OCD MT Cap is an aid for a physical procedure (MT determination), not an AI diagnostic tool used by human readers. No MRMC study was performed.

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

• Not applicable. The OCD MT Cap is described as a "single-use wearable device that is intended to be used as an optional aid during the OCD Motor Threshold (MT) determination process." It is a tool to facilitate a human clinician's action, not a standalone algorithm.

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

• Not applicable for clinical performance. For the usability testing, the "ground truth" would be the successful aid to clinicians in determining the patient's unique MT location, as confirmed by the usability study results. However, the exact methodology for establishing this success (e.g., expert observation, user feedback metrics) is not detailed.

8. The sample size for the training set:

• Not applicable. No machine learning algorithm or AI component requiring a "training set" is described for the OCD MT Cap.

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

• Not applicable. No training set was used.

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The NeuroStar Advanced 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 failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

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

The NeuroStar Advanced 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 induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:

• Mobile Console
• System Software
• Treatment Chair
• Ferromagnetic Treatment Coil
• Head Support System
• SenStar® Connect Treatment Link & SenStar® Treatment Link
• Treatment Pack (for use with the SenStar® Connect Treatment Link)
• MT Cap
• TrakStar™ Patient Data Management System
• D-Tect™ MT Accessory
• Beam F3 Treatment Pack

There are two proposed changes to the NeuroStar Advanced Therapy System that are the subject of this 510(k). The first proposed change introduces the capability to use wireless communication to transfer data between the NeuroStar System software and the TrakStar Patient Data Management System, as an alternative to using an ethernet cable to facilitate this transfer. The second proposed change allows for the alternative use of the Beam F3 treatment location method (herein: "Beam F3 method"), in addition to the current method that utilizes a location 5 cm away from the motor threshold within the dorsolateral prefrontal cortex (DLPFC) reqion of the brain. The Beam F3 method requires measuring different skull dimensions and uses these values to calculate the F3 treatment location, which is also located within the DLPFC. This 510(k) introduces software embedded into the NeuroStar System that performs these calculations as well as single-use measuring accessories. Once the F3 treatment location is determined, the treatment parameters and protocols remain the same as those used in the currently marketed NeuroStar Advanced Therapy System.

This document does not contain an acceptance criteria table or a detailed study proving the device meets specific performance criteria through clinical testing. Instead, it is a 510(k) premarket notification summary from the FDA, asserting substantial equivalence to previously cleared predicate devices.

The key statement is on page 5: "Clinical Testing: There is no clinical testing required to support this submission."

Therefore, I cannot provide the full response as requested, as the necessary information regarding acceptance criteria, reported performance, test set details, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in the provided document.

The document focuses on demonstrating that the proposed changes (wireless communication and the Beam F3 treatment location method) to the NeuroStar Advanced Therapy System do not raise new questions of safety or effectiveness when compared to its predicate devices. The "Performance Standards" section lists recognized consensus standards (ISO 10993-1, ANSI AAMI ES60601-1 / IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6) and mentions non-clinical performance testing and usability testing were performed according to relevant guidance documents. However, this is related to safety and electrical performance, not clinical efficacy or device performance against specific metrics as would be found in a detailed clinical study report proving accuracy or effectiveness.

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