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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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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 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 CloudTMS for OCD is intended to be used as an adjunct for the treatments suffering from Obsessive-Compulsive Disorder (OCD).

The CloudTMS 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 bilateral dorsomedial prefrontal cortex (DMPFC) for the treatment of Obsessive-Compulsive Disorder (OCD).

The CloudTMS for OCD principle of operation is based on the discharge of high voltage capacitor (1.8 kV) through stimulation coil; 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. In the OCD treatment protocol, the repetitive transcranial magnetic pulses are applied at a frequency of 20 Hz.

The CloudTMS for OCD consists of the following main components:

• . Mobile console
• Cooling unit .
• Extra power supply unit ●
• System software with GUI ●
• Treatment chair*
• Head support system*
• Coil DCC-03-125-C for both MT and treatment ●
• K8 Coil fixture
• K3 flexible arm coil positioning system ●
• Data Management System ●
• Trolley with casters .
• (* optional)

The acceptance criteria and study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The provided document describes a non-clinical performance study to demonstrate substantial equivalence to a legally marketed predicate device (Tonica Electronik A/S, MagVenture TMS Therapy System for Treatment of OCD, K193006). The study primarily focused on comparing the technological characteristics of the new device (CloudTMS for OCD) with the predicate device.

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

No test set of patient data was used. This was a non-clinical study focused on device characteristics and substantial equivalence, not a clinical trial with patient outcomes. Therefore, data provenance is not applicable in this context.

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):

Not applicable. No ground truth was established by experts for a test set of patient data, as this was a non-clinical substantial equivalence submission.

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

Not applicable, as no external 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. This was not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable, as this is a medical device, not an algorithm, and the focus was on hardware and operational parameter equivalence.

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

For this substantial equivalence application, the "ground truth" was the established and legally marketed predicate device (K193006) and its characterized technological parameters as specified in its FDA clearance. The new device's performance was compared against these established specifications.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable, as no training set was used.

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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, for adjunctive treatment of OCD, 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 structure. The system consists of: 1. Mobile console 2. System software with GUI 3. Treatment chair 4. Head support system 5. Coil positioning system 6. Same Coil for both MT and treatment 7. Coil fixture 8. Data management system.

The provided text describes the regulatory clearance for the NeuroStar Advanced Therapy System for the
adjunctive treatment of Obsessive-Compulsive Disorder (OCD). The submission is a 510(k) premarket
notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, the study design focuses on proving equivalence rather than meeting pre-defined acceptance
criteria based on clinical efficacy outcomes or standalone algorithm performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are
primarily focused on demonstrating that the device's technological characteristics, safety, and
performance are equivalent to a predicate device. There aren't traditional clinical efficacy
acceptance criteria (e.g., a specific percentage improvement in OCD symptoms) as would be seen in a
PMA or a clinical trial designed to establish de novo efficacy.

The "acceptance criteria" are therefore implicit in the comparison to the predicate device and the
adherence to recognized standards.

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

The document explicitly states: "This 510(k) does not contain any pivotal clinical trial data related
to the new device. The substantial equivalency is established based on similar technological
characteristics." Therefore, there is no clinical "test set" in the traditional sense of patient
data for efficacy. The "test set" here refers to bench testing data comparing the subject device's
physical characteristics to the predicate device. The provenance of this bench testing data is not
specified (e.g., where the tests were physically conducted), but it refers to well-established
scientific methods using standard scientific instrumentation. The specific sample sizes for these
bench tests (e.g., number of coils tested) are not provided.

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

Not applicable. There was no clinical "test set" requiring expert ground truth in the context of this
510(k) submission, which relied on bench testing and comparison to a predicate.

4. Adjudication method for the test set

Not applicable, as there was no clinical "test set" or expert review process for patient outcomes.

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, not an AI or imaging
diagnostic device, and no MRMC study was conducted or is 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 medical device for treatment, not an algorithm. The "device performance"
reported relates to its physical and functional characteristics (e.g., magnetic field, sound levels)
and adherence to safety standards, not an algorithm's standalone diagnostic performance.

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

For the bench testing, the "ground truth" was established by measurements using well-established
scientific methods and standard scientific instrumentation, as referenced in Section 4 of the FDA's
Class II Special Controls Guidance document for rTMS systems. This involves physical measurements of
magnetic and electric fields.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML algorithm that undergoes
machine-learning training. The device's design and parameters are established through engineering and
medical principles, not statistical learning from data.

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

Not applicable. No training set for an algorithm was used.

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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 - for adjunctive treatment of OCD 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. The MagVenture TMS Therapy system - for treatment of OCD is indicated as an adjunct for the treatment of adult patients who are suffering from Obsessive-Compulsive Disorder (OCD). MagVenture TMS Therapy system has previously obtained FDA clearance for treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode (K150641, K171481, K172667 and K173620).

Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons. The standard-of-care FDA cleared TMS protocol for treatment of OCD uses repetitive transcranial magnetic pulses applied at a frequency of 20 Hz. The safety and effectiveness for treatment of OCD have been established in a clinical trial that lead to an FDA De Novo clearance of the primary predicate device, the Brainsway DTMS system. The present 510(k) does not include new pivotal data, but includes clinical trial data on more than 500 subjects treated with the Mag Venture TMS Therapy System, in order to demonstrate performance and safety. Treatment of OCD is applied to the human brain of the bilateral dorsomedial prefrontal cortex (DMPFC) using 20 Hz TMS for 18 min. The treatment parameters are identical to those recommended by the Primary Predicate Device.

The MagVenture TMS Therapy system – for adjunctive treatment of OCD is an integrated system consisting of the following components:

• MagPro Stimulator and Trolley .
• MagPro Family (R30, R30 w. MagOption, X100, X100 w. MagOption) o
• Trolley with holding arrangements o
• Coil for MT determination and OCD treatment .
• Coil Cool D-B80 with Coil Cooler Unit o
• Marking apparatus for locating treatment area .
• Pen for marking, Cap, Ruler o
• Patient head fixation .
• Treatment Chair o
• Vacuum Pump and Vacuum pillow o
• Super Flexible Arm mounted on the trolley o
• Isolation Transformer .

The provided text is a 510(k) summary for the MagVenture TMS Therapy System for adjunctive treatment of OCD. It describes the device, its intended use, and argues for 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:

No specific acceptance criteria table for effectiveness is provided in the document. The document establishes substantial equivalence based on prior clearances, identical intended use and treatment parameters with a primary predicate device, and non-clinical and clinical data supporting safety and performance.

The acceptance of this device seems to be primarily based on demonstrating a substantial equivalence to an already cleared predicate device (Brainsway Deep Transcranial Magnetic Stimulation (DTMS) system, HAC – H7 coil (DEN170078, K183303)) in terms of safety and performance for the adjunctive treatment of OCD.

The document states: "The new device is substantially equivalent to the primary predicate device in terms of performance, effectiveness and safety."

Here's a breakdown of the requested information based on the provided text:

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

As mentioned, no explicit table of acceptance criteria for effectiveness is present. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the primary predicate device, particularly regarding its ability to treat OCD. The reported device performance is discussed in terms of its similarity to the predicate and general safety/tolerability demonstrated in other studies.

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

• Test Set for Effectiveness (Implicitly for OCD): The primary predicate device's pivotal trial (Carmi et al. (2)) included a total of n=99 subjects, of which n=50 received active TMS treatment for OCD. The provenance of this data is a "Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial." (Page 12, reference 2). This study's country of origin is not explicitly stated in this document but is typically associated with the predicate manufacturer (Brainsway Ltd., Israel).
• Test Set for Safety and Performance of the New Device: "clinical trial data on more than 500 subjects treated with the MagVenture TMS Therapy System" (Cool D-B80 coil). This data focuses on safety and general performance (e.g., determining Motor Threshold). "Most of the clinical research performed using the new device has been conducted outside the USA." (Page 7). Most research focused on treatment-resistant depression (TRD) or major depressive disorder (MDD), but the document argues for relevance to OCD due to shared underlying deficits and similar treatment targeting. A "small pilot trial using the new device also demonstrated a clinically and statistically significant effect of treatment of OCD," but the number of subjects for this specific OCD trial is described as "low number of subjects" and not specified further.

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

The document does not provide details on the number or qualifications of experts for establishing ground truth specifically for the effectiveness test set. The effectiveness relies on the previously published pivotal trial for the primary predicate device (Carmi et al.), which would have utilized clinical diagnoses and outcome measures as ground truth. For the predicate study, the "ground truth" for OCD diagnosis would have likely been established by qualified psychiatrists or clinicians using standardized diagnostic criteria (e.g., DSM-V).

4. Adjudication method for the test set

The document states that the primary predicate device's pivotal trial was a "Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial." (Page 12, reference 2). This implies a rigorous study design where treatment assignments and outcome assessments would have been blinded, contributing to the establishment of reliable "ground truth" regarding treatment efficacy. However, a specific "adjudication method" beyond standard blinded clinical trials is not explicitly detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This device is not an AI/CAD system evaluated by human readers interpreting images. It is a medical device for direct therapeutic intervention. The "effectiveness" is assessed by measuring clinical outcomes in patients.

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

This question is not applicable as the device is a TMS therapy system, not an algorithm or AI. It is a physical device that delivers magnetic stimulation to the brain for therapeutic purposes. Human operators are involved in setting up and operating the device for patient treatment.

7. The type of ground truth used

• For effectiveness (via predicate study): Clinical diagnosis of Obsessive-Compulsive Disorder (OCD) and clinical outcome measures (e.g., symptom severity scales like Y-BOCS - Yale-Brown Obsessive Compulsive Scale, though not explicitly mentioned here, this is standard for OCD trials) in a controlled clinical trial setting.
• For safety/performance of the new device: Clinical observation of adverse events, tolerability, and physiological measurements (e.g., Motor Threshold determination).

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning or AI. The device is a physical medical device. The closest analogy might be the clinical data supporting the device's original clearances for MDD, which forms the basis of its design and operational parameters. The document mentions "clinical trial data on more than 500 subjects treated with the MagVenture TMS Therapy System," mostly for MDD, which informed safety and general operational performance, effectively acting as "training" for understanding the device's characteristics in a clinical setting.

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

Again, this is not a machine learning context. For the clinical data on >500 subjects (mostly MDD), the "ground truth" for the disease state would have been clinical diagnoses of MDD or TRD by qualified medical professionals using standard diagnostic criteria. For safety aspects, reported adverse events and clinical assessments would have constituted the "ground truth."

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The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

The proposed device is a modification to the Brainsway Deep TMS System that was cleared under DEN170078. Brainsway has implemented minor changes to the helmet configuration, improved the user interface, modified the measurement method, and made other minor component changes. None of these changes alter the technical specifications for the device, which maintains the same voltage and current, same frequencies, and same electrical mains compatibility. The same technological features have previously been cleared by FDA for use in major depressive disorder in K173540.

Consistent with the predicate and reference device, the proposed Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures. 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 pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.

The provided text describes modifications to the Brainsway Deep TMS System and asserts its substantial equivalence to a previously cleared predicate device. It does not provide detailed acceptance criteria or results of a clinical study to prove the device meets specific performance criteria. Instead, it focuses on demonstrating that the modifications do not introduce new questions of safety or effectiveness compared to the predicate device.

Therefore, many of the requested details about acceptance criteria, clinical study methodology, and ground truth establishment cannot be found in the provided document. The document primarily confirms that the modified device functions as intended and meets the same acceptance criteria as the predicate and reference devices, based on software verification, electrical safety, EMC, and bench performance testing.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding reported device performance for a clinical study proving efficacy or diagnostic accuracy. Instead, it states:

"In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device."

This implies that the acceptance criteria are generally related to the proper functioning of the device, electrical safety, electromagnetic compatibility, and bench performance, rather than clinical efficacy metrics. For an efficacy study demonstrating treatment outcomes for OCD, such details would typically be found in a separate clinical study report.

The "Indications for Use" section states: "The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder." This is the clinical claim, but the document doesn't present a study proving the device meets this claim with performance metrics. It relies on the substantial equivalence to the predicate device, which presumably had clinical data supporting its efficacy for this indication.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided in the document. The document describes "software verification and validation," "electrical safety," "EMC," and "bench performance testing." These are engineering and performance validation tests, not typically clinical studies with "test sets" of patient data in the sense of a machine learning model.
• If a prior clinical study for the predicate device existed for OCD treatment, that information is not detailed here.

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

• Not applicable / Not provided. Since this document describes engineering and bench testing, rather than a clinical trial or an AI/diagnostic device study requiring expert ground truth establishment for a patient dataset, this information is not relevant to the described testing.

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

• Not applicable / Not provided. See explanation for #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. This document describes a medical device (Transcranial Magnetic Stimulation System) for treatment, not an AI-assisted diagnostic or imaging device used by "human readers." Therefore, an MRMC study is not relevant to the described device.

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

• Stand-alone performance was indirectly evaluated through bench testing and compliance. The device itself is a "human-in-the-loop" device as it delivers treatment under medical supervision. The "standalone" performance here refers to the device's technical specifications and electrical/mechanical performance, which was assessed through the described tests (software, electrical safety, EMC, bench performance). The document states: "In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate and reference device." This implies standalone technical performance testing.

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

• For the technical and safety testing described (software, electrical safety, EMC, bench performance):
  • Ground Truth: Engineering specifications, regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2), and comparison to the performance of the predicate and reference devices. The "ground truth" is that the device should operate within specified technical parameters and safety limits.
• For the clinical efficacy of the device for OCD treatment (which is its intended use):
  • The document implies that the predicate device (DEN170078) already established clinical efficacy for OCD. This specific document for K183303 relies on "substantial equivalence" and does not describe a new clinical trial for efficacy. If such a trial existed for the predicate, the ground truth would likely have been clinical outcome measures for OCD (e.g., Yale-Brown Obsessive Compulsive Scale (YBOCS) scores or similar psychiatric outcome scales).

8. The sample size for the training set

• Not applicable / Not provided. The Brainsway Deep TMS System is a Transcranial Magnetic Stimulation device, not an AI/machine learning algorithm that requires a "training set" of data in the common sense. Its "training" is its engineering design and manufacturing.

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

• Not applicable / Not provided. As explained in #8, there is no "training set" in the context of an AI model for this device.

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The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

The Brainsway DTMS System enables direct non-invasive activation of brain structures. 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 to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.

The Brainsway DTMS System is composed of the following five main components:

• Electromagnetic Coil (HAC-Coil)
• TMS Neurostimulator
• Cooling System
• Positioning Device
• Personal Head Cap

The provided text describes a clinical study to establish the safety and effectiveness of the Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System for the treatment of Obsessive-Compulsive Disorder (OCD).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for effectiveness appear to be based on the primary effectiveness endpoint: a statistically significant reduction in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores compared to sham treatment. Additionally, clinically meaningful reductions in OCD severity are highlighted.

The ITT analysis set (N=99) did not achieve statistical significance (p-value: 0.0988) due to a higher reduction in YBOCS in the Sham group (4.1 points) compared to the mITT Sham group (3.3 points), but a clinically meaningful reduction (6.0 points) was still observed in the DTMS group. |
| Secondary Endpoints:

• Response rate (≥30% YBOCS reduction from baseline) at 6 weeks.
• Partial Response rate (≥20% YBOCS reduction from baseline) at 6 weeks.
• Improvement in CGI-I ("Improved" category: moderately improved to very much improved) at 6 weeks.
• Improvement in CGI-S ("Improved" category) at 6 weeks.
• Sustained YBOCS reduction at 10 weeks. | Met (with qualifications):
• Response Rate: DTMS: 38.1% (16/42), Sham: 11.1% (5/45) in mITT.
• Partial Response Rate: DTMS: 54.8% (23/42), Sham: 26.7% (12/45) in mITT.
• CGI-I "Improved": DTMS: 49% (20/41), Sham: 21% (9/43) in mITT.
• CGI-S "Improved": DTMS: 61% (25/41), Sham: 33% (14/43) in mITT.
• YBOCS at 10 Weeks: Adjusted mean YBOCS reduction of 6.5 points (95% CI: [4.3;8.7]) in the DTMS group, indicating stability.

(Note: Formal statistical testing was stopped at the first secondary endpoint, so p-values for other secondary endpoints were unadjusted for multiplicity, but results show favorable trends for DTMS). |
| Safety: Device is safe and tolerable, with adverse events being minor, reversible, and typical for TMS devices, and no significant differences in vital signs, physical/neurological exams, or cognitive status between treatment groups. Absence of serious related adverse events. | Met:

• AEs reported by 73% (DTMS) vs. 69% (Sham).
• Most frequent AE was headache (37.5% DTMS, 35.3% Sham).
• Other pain/discomfort (administration site, jaw, facial, muscle, neck, dizziness) were mild/moderate and resolved.
• No reports of hypoacusis (hearing loss).
• No notable differences in vital signs, physical/neurological exams between groups.
• One SAE reported, assessed as not device-related (suicidal thoughts preceding study). |

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

• Test Set (Clinical Study Population):
  • Total enrolled: 100 subjects.
  • ITT Analysis Set (received at least one treatment): 99 subjects (48 DTMS, 51 Sham).
  • mITT Analysis Set (met eligibility criteria): 94 subjects (47 DTMS, 47 Sham). This was the principal data analysis set for efficacy.
  • Per-Protocol Analysis Set (without major protocol deviations): 93 subjects (46 DTMS, 47 Sham).
• Data Provenance: Prospective, randomized, double-blinded, multi-site, sham-controlled clinical trial. The study was conducted at 11 study sites in the United States (9 sites), Israel (1 site), and Canada (1 site).

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

• The ground truth for the effectiveness of the treatment was established through clinical assessments using standardized scales like the YBOCS, Sheehan Disability Scale (SDS), and Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I).
• These assessments were performed by independent raters. While the exact number of independent raters or their specific qualifications (e.g., years of experience as psychiatrists or psychologists) is not explicitly stated, the study design mentions that "the independent rater" was blinded to the treatment administered. This implies that trained clinical professionals, likely psychiatrists or psychologists, administered these critical rating scales.

4. Adjudication Method for the Test Set

• The study design involved a double-blinded approach where both study personnel (including the operator and independent rater) and study subjects were blinded to whether active or sham treatment was administered.
• The primary and secondary outcome measures (YBOCS, SDS, CGI-S, CGI-I) are standardized clinical scales that are typically administered by trained personnel. There is no explicit mention of an "adjudication method" like 2+1 or 3+1 for discordance between multiple experts for individual case ground truth, as these scales are designed for direct clinical assessment. The "ground truth" here is the patient's symptom severity and improvement as measured by these scales.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study directly evaluated the effectiveness of a medical device (DTMS system) for treating OCD in patients, not an AI system assisting human readers. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable to this study.

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

• No, a standalone (algorithm only) performance study was not done. The study evaluated a medical device that is administered to patients by trained operators, with outcomes assessed by independent clinical raters. This is a human-in-the-loop system in the context of patient treatment and assessment, not an AI algorithm acting autonomously.

7. The Type of Ground Truth Used

• The ground truth used for determining treatment effectiveness was based on expert clinical assessments and standardized patient-reported outcomes. Specifically:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS): A clinician-administered scale that measures the severity of OCD symptoms.
  • Sheehan Disability Scale (SDS): A patient-rated scale that assesses functional impairment.
  • Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I): Clinician-rated scales that measure global severity and improvement of illness.
  • Response/Remission Definitions: Pre-defined thresholds of YBOCS score reduction or absolute score for clinical response and remission.
• For safety, ground truth was assessed through adverse event reporting, vital signs, physical/neurological examinations, and cognitive tests.

8. The Sample Size for the Training Set

• This was a clinical trial evaluating a medical device, not a machine learning model. Therefore, there was no "training set" in the context of machine learning model development. The sample size used for the clinical study (94-99 subjects in the analysis sets) was for direct evaluation of the device's efficacy and safety.

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

• As there was no machine learning "training set," this question is not applicable. The clinical trial directly provided the data (including outcome measures like YBOCS scores) used to assess the device's performance.

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