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

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

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

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

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

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

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

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

This submission introduces the following modifications:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Specifically, the document states:

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

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

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The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

The non-clinical performance data included:

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

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

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

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

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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 Nexstim Navigated Brain Therapy (NBT®) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Nexstim Navigated Brain Therapy (NBT®) System is a non-invasive, repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder (MDD) without inducing seizure in patients who have failed one (1) antidepressant medication.

The Nexstim NBT System 2 is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.

The Nexstim NBT System 2 consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBT System 2 is provided by the software.

The Nexstim NBT System 2 combines magnetic resonance imaging-based (MRI-based), three dimensional (3D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy.

The Nexstim NBT System 2 software is used to import a patient's MR image slices to generate an accurate 3D model of the patient's head which can be electronically peeled back to reveal the anatomical structures of the brain.

The provided text is a 510(k) Premarket Notification from the FDA for the Nexstim Navigated Brain Therapy (NBT) System 2. This document is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed clinical study demonstrating the device's efficacy against specific, quantitative acceptance criteria in the manner one might see for a diagnostic AI.

The "acceptance criteria" discussed in this document are primarily related to technical specifications and regulatory compliance for a neurostimulation device, and the "study" proving it meets them refers to verification and validation activities against these technical standards, and a direct comparison to a predicate device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not explicitly detailed within this type of regulatory submission because the approval is based on demonstrating equivalence in technical characteristics and safety/performance, not on a novel clinical efficacy trial with specific, quantitatively defined "acceptance criteria" for a diagnostic algorithm's performance on a test set.

However, I can extract and present the information that is available and relevant to your request based on the provided document.

Acceptance Criteria and Device Performance (Based on Technical Equivalence)

The acceptance criteria here are implicitly met by demonstrating that the proposed device (Nexstim NBT® System 2 (Proposed Device)) is substantially equivalent to the predicate device (Tonica Electronik A/S Mag Vita TMS Therapy System w/ Theta Burst Stimulation ([K173620](https://510k.innolitics.com/search/K173620))) and the previously cleared version of its own device (Nexstim Navigated Brain Therapy (NBT®) System 2 ([K171902](https://510k.innolitics.com/search/K171902))), particularly for the new Intermittent Theta Burst (iTBS) Protocol. The "performance" is demonstrated by showing that the key technical characteristics are the same or comparable, and that compliance with relevant standards has been achieved.

Note: The performance here is primarily about technical specifications rather than statistical performance metrics (like sensitivity, specificity, AUC) for a diagnostic output, as this is a therapeutic rather than a diagnostic device, and the submission is focused on substantial equivalence.

Study Details:

1. Sample Size used for the Test Set and Data Provenance:

   • This submission is a 510(k) premarket notification primarily demonstrating substantial equivalence for a therapeutic device (rTMS system for MDD), specifically adding a new treatment protocol (iTBS).
   • The document does not describe a specific clinical "test set" or study in the sense of an independent data set used to evaluate a diagnostic algorithm's performance. Instead, it relies on:
     • Bench testing and verification/validation activities against technical standards (listed in the table above).
     • Comparison to a legally marketed predicate device (Tonica Electronik A/S / Mag Vita TMS Therapy System w/ Theta Burst Stimulation, K173620), which already had the iTBS protocol cleared.
     • Comparison to its own previously cleared device version (K171902) to show that existing features remain unchanged or are consistent.
   • Therefore, there's no "sample size" for patients/cases in a typical AI/diagnostic study sense within this document for a "test set." The document focuses on technical and safety equivalence.

2. Number of Experts used to establish the Ground Truth for the Test Set and Qualifications of those Experts:

   • Not applicable in the context of this 510(k) submission. This is not a study assessing the diagnostic performance of an AI against expert ground truth. The "ground truth" for this device's function is its ability to deliver the specified magnetic stimulation parameters accurately and safely, and for the clinical efficacy of this type of therapy for MDD, which is established by larger clinical trials for the class of devices and specific protocols (e.g., those reviewed for the predicate device).

3. Adjudication Method for the Test Set:

   • Not applicable. No external "test set" requiring expert adjudication is described.

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

   • Not applicable. This device is a therapeutic rTMS system, not a diagnostic AI system intended to assist human readers. Therefore, an MRMC study is not relevant to this submission.

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

   • Not applicable in the traditional sense of a diagnostic algorithm. The device itself (the Nexstim NBT System 2) operates based on software control and delivered TMS pulses. Its "standalone performance" is implicitly demonstrated through the various verification and validation activities (software, electrical safety, EMC, bench testing), which confirm it functions according to its predetermined specifications, independently of a human operator, in terms of delivering the therapy. The clinical use always involves a trained medical professional.

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

   • The "ground truth" for this submission is multi-faceted, aligning with the nature of a therapeutic device and a substantial equivalence review:
     • Technical Specifications: The core "ground truth" for the device itself is its adherence to specified physical parameters (magnetic field intensity, frequency, pulse length, etc.) and compliance with recognized industry standards (IEC, ISO, FDA guidance) for safety and performance. This is verified through bench testing and engineering evaluations.
     • Predicate Device Performance: The "ground truth" for clinical effectiveness of the iTBS protocol is based on the established performance of the predicate device (K173620) which already had clearance for this protocol. The submission argues that since the proposed device's technical characteristics for delivering iTBS are equivalent, its clinical effect would also be equivalent.
     • Clinical Effectiveness of rTMS for MDD: The broader "ground truth" for the treatment of Major Depressive Disorder with rTMS is established by clinical outcomes data from pivotal studies that led to the approval of the predicate device and other similar rTMS systems for MDD. This document refers to the established indication for use for rTMS in MDD, rather than presenting new clinical trial data for this specific device's efficacy beyond the established equivalence.

7. The sample size for the training set:

   • Not applicable. This document describes a medical device seeking 510(k) clearance, not an AI/machine learning algorithm undergoing training with a specific dataset. The software is developed and verified via traditional software engineering processes, not "trained."

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

   • Not applicable. As there is no "training set" for an AI/ML algorithm, no ground truth needed to be established in that context.

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The Neurosoft TMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Neurosoft TMS 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 Maior Depressive Disorder.

The Neurosoft TMS 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.

The Neurosoft TMS consists of the following main components:

• Main unit of the magnetic stimulator
• Cooling unit
• Extra power supply unit
• Coils
• Cooled figure-of-eight coil FEC-02-100-C
• Cooled figure-of-eight coil AFEC-02-100-C
• Figure-of-eight coil FEC-02-100 (optional)
• Figure-of-eight coil AFEC-02-100 (optional)
• K8 coil holder
• K3 flexible arm for coil positioning
• Trolley with casters

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as well, as this is a 510(k) summary, which often relies on comparison to predicate devices rather than de novo clinical studies for performance.

Important Note: The provided document is a 510(k) premarket notification summary for a medical device (Neurosoft TMS). Such submissions typically demonstrate substantial equivalence to a previously cleared predicate device, rather than proving direct clinical efficacy through new, large-scale clinical trials. Therefore, information regarding clinical effectiveness studies, particularly those involving human readers, ground truth establishment through expert consensus or pathology, and detailed statistical performance metrics like sensitivity/specificity for AI algorithms, are generally not present in these types of documents for TMS devices. The focus here is on non-clinical performance (safety, electrical, mechanical) and a comparison of technical specifications.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for the Neurosoft TMS are primarily based on demonstrating substantial equivalence to its predicate devices, especially its own prior version (Neurosoft TMS K160309) and the MagVita TMS Therapy System (K171481). The key "performance" demonstrated relates to its technical specifications matching or being comparable to these cleared devices, and changes not introducing new safety concerns.

Table of Acceptance Criteria and Reported Device Performance

• Magnetic Field Intensity: 120% of the MT
• Frequency: 10 Hz
• Train duration: 4 sec
• Inter-train interval: 11-26 sec (Modified from fixed 26 sec in K160309, comparable to MagVita)
• Number of trains: 75
• Magnetic Pulses per Session: 3000
• Treatment Session Duration: 18.8 min-37.0 min (Due to variable inter-train interval)
• Sessions/week: 5
• Treatment Schedule: 5 daily sessions for 6 weeks
• Area of brain to be stimulated: Frontal Cortex |
  | Device Components | Comparable components (Main unit, Cooling unit, Power supply, Coils, Coil holders, Flexible arm, Trolley). | Lists identical and optional coils (FEC-02-100-C, AFEC-02-100-C, FEC-02-100, AFEC-02-100). "The Neurosoft TMS and the predicate devices have the same components..." |
  | Coil Specifications | Comparable coil designs (figure-of-eight, air core, cooling methods) and parameters (Inner/Outer diameter, Area, Inductance, Amplitude in SMT units, Waveform, Active pulse width, Max initial dB/dt). | Detailed specifications for all listed coils provided, showing close similarity to K160309 and comparable ranges to MagVita. |
  | Safety Standards | Compliance with relevant electrical safety and quality standards (e.g., IEC 60601-1, ISO 13485, ISO 14971). | "Complies with IEC 60601-1 and IEC 60601-1-2."
  "Company complies with DIN EN ISO 13485: 2012, ISO 10993-1: 2009, ISO 14971: 2007." |
  | Non-clinical Performance | Satisfactory performance in required non-clinical tests as demonstrated for the predicate device (K160309). | "The non-clinical performance testing of Neurosoft TMS has been tested as required, and cleared by the FDA earlier on K160309. These tests demonstrate that the Neurosoft TMS is safe and effective for use in treatment of Major Depressive Disorder." |
  | New Safety Concerns | The modifications (e.g., variable inter-train interval) should not introduce any new safety considerations. | "On the basis of the only modification of the treatment parameter, the Neurosoft TMS does not introduce any new safety considerations in comparison to the predicate device. All other identified differences between the two systems are minor and without any known impact on safety or efficacy." |

Study Information (Based on the Provided Document):

The document primarily refers to non-clinical performance data and relies on the substantial equivalence paradigm rather than a new clinical study for this specific 510(k) submission.

1. Sample sizes used for the test set and the data provenance:

   • No specific sample size for a "test set" or clinical trial is provided. The document refers to "non-clinical performance testing."
   • Data Provenance: Not specified in terms of country of origin. The testing is described as having been "tested as required, and cleared by the FDA earlier on K160309," implying the data underpinning the original clearance (and now referenced) would be from the manufacturer's internal testing as part of their regulatory submissions. The nature of these tests (e.g., electrical, mechanical, EMC) would be retrospective from the previous submission perspective.

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

   • Not applicable / Not specified. As this is a 510(k) for a TMS device based on substantial equivalence and non-clinical data, there is no mention of a ground truth established by human experts for performance evaluation in the context of an AI/human reader study. The "ground truth" for a TMS device's safety and effectiveness is typically established through a combination of regulatory standards, engineering principles, and clinical data from predicate devices or general scientific consensus on the treatment.

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

   • Not applicable / None specified. No clinical test set involving human readers or expert adjudication is described in this document.

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

   • No MRMC study was done or reported in this document. This device is a direct treatment device (rTMS system), not an imaging analysis or diagnostic AI tool that would typically involve MRMC studies.

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

   • Not applicable. This device is a hardware system for direct medical treatment; it is not an algorithm for diagnostic interpretation in the way AI/ML software as a medical device (SaMD) might be evaluated for standalone performance. The "algorithm" here refers to the internal programming of the TMS device to deliver stimulation according to parameters.

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

   • For the device's fundamental function (producing magnetic fields of specific parameters), the "ground truth" would be physical measurements and engineering specifications.
   • For the device's clinical indication (treatment of MDD), the "ground truth" used for prior clearances (and thus for this substantial equivalence claim) would be the clinical evidence supporting the predicate devices' efficacy (which may have originally involved clinical trials measuring patient outcomes or expert clinical assessments of depression severity). This document itself does not detail new outcomes data.

7. The sample size for the training set:

   • Not applicable / Not specified. This document does not describe a machine learning model with a "training set."

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

   • Not applicable. As no machine learning training set is described.

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