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

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components:

• Mobile Console
• System Software
• Treatment Chair
• Head Support System
• TrakStar PC
• TrakStar Software

The NeuroStar Advanced Therapy System is indicated for treating depressive episodes and decreasing anxiety symptoms in adult patients with Major Depressive Disorder (MDD) who have not achieved satisfactory improvement from previous antidepressant medication.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes used for the test set and data provenance:
   The clinical performance data supporting the expanded indications primarily relies on two Randomized Controlled Trials (RCTs) and supportive real-world data (RWD) and observational studies.

   • RCTs (Test Set):

     • O'Reardon et al. (2007/2008): N=301 patients (Active: 155, Sham: 146). Data provenance is from a clinical trial that evaluated the safety and efficacy of the device for MDD.
     • George et al. (2010): N=190 patients (Active: 92, Sham: 98). Data provenance is from a company-independent, NIMH-funded trial.

   • Supportive Data (Test Set/Observational):

     • TrakStar (2022) study (unpublished): N=664 patients. This is a large-scale retrospective analysis of real-world data (RWD) derived from the TrakStar registry data, collected from patients across 75 TMS centers in the US over 13 years (since 2008). This is retrospective data.
     • Tuinstra et al. (2022): N=77 patients (57 with clinically significant anxiety symptoms). This is a retrospective analysis of medical records from patients with MDD and comorbid anxiety symptoms, over 3.5 years.

   The provenance is primarily retrospective clinical trial data (for the original MDD indication, now leveraged for anxiety) and retrospective real-world data/medical chart reviews for the updated anxiety indication. The country of origin for the studies is not explicitly stated for all, but given the US FDA submission and typical clinical trial conduct for device clearances, it's highly probable to be primarily US-based, especially for the TrakStar registry.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   The studies described are clinical trials and retrospective analyses of patient outcomes. "Ground truth" in this context refers to the documented clinical status of patients (e.g., diagnosis of MDD, anxiety symptoms, response to treatment, remission). While clinical diagnoses and symptom assessments would typically be performed by qualified clinicians (e.g., psychiatrists, physicians), the specific number of experts involved in establishing the initial diagnoses or ground truth for each patient in the test sets, or their specific years of experience, is not specified in the provided text. The studies utilized standardized psychiatric rating scales (HAMD-17, HAMD-24, HAMD – A/S F, PHQ-9, GAD-7), suggesting these were administered and interpreted by trained personnel.

4. Adjudication method for the test set:
   The provided text does not explicitly detail any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or evaluating patient outcomes in the test sets. The RCTs and observational studies would have relied on standard clinical assessment procedures and the reporting of scores from validated psychiatric rating scales.

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, an MRMC comparative effectiveness study was not done. The NeuroStar Advanced Therapy System is a Transcranial Magnetic Stimulation (TMS) device, which is a therapeutic device targeting brain regions for treatment, not an AI-assisted diagnostic tool that requires human readers to interpret images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

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 device is a therapeutic system that is administered by clinicians to patients. Its performance is evaluated through clinical trials and real-world usage in human subjects, not as an isolated algorithm.

7. The type of ground truth used:
   The ground truth used for these studies is clinical outcomes data and expert-evaluated patient status according to standardized psychiatric rating scales.

   • Diagnosis of Major Depressive Disorder (MDD), confirmed by clinicians.
   • Level of depressive symptoms measured by scales like HAMD-17, HAMD-24, and PHQ-9.
   • Level of anxiety symptoms measured by scales like HAMD – A/S F and GAD-7.
   • Response to treatment (e.g., ≥50% reduction in symptom scores, or ≥6 point reduction for GAD-7/PHQ-9).
   • Remission (e.g., GAD-7 < 5, PHQ-9 < 5, HAMD AS/F < 7).

8. The sample size for the training set:
   The provided information describes clinical studies primarily for validation or performance demonstration of the device for specific indications. It does not mention a "training set" in the context of machine learning model development. The NeuroStar Advanced Therapy System is a physical medical device, not an AI/ML algorithm whose parameters are iteratively "trained" on data. The clinical data presented is for demonstrating safety and effectiveness.

9. How the ground truth for the training set was established:
   As no explicit "training set" in the AI/ML sense is mentioned for this device, this question is not directly applicable. If interpreting "training set" loosely as the cumulative clinical experience and data that informed the device's development or initial indications, the "ground truth" would have been established through a combination of medical understanding of MDD, clinical research, previous clinical trials, and regulatory requirements for therapeutic interventions.

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The NeuroStar Advanced Therapy System 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 NeuroStar Advanced Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Maqnetic Stimulation (TMS). NeuroStar Advanced Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar Advanced Therapy is used for patient treatment by prescription only under the supervision of a licensed physician and can be used in both inpatient and outpatient settings including physician's offices, clinics, and hospitals. NeuroStar Advanced Therapy uses a well-understood property of physics regarding the law of electromagnetic induction, which states that a time-varying or moving magnetic field will induce an electric current in an adjacent conductive substance with the electric current traveling in a direction perpendicular to the motion of the magnetic field. NeuroStar Advanced Therapy uses a generated magnetic field as a vector for delivering an electrical current to a tarqet conductor of interest, which in therapeutic application, is the brain. By using this method of delivering electrical current to the brain the electrical current produced in the brain can be delivered in an anatomically focused manner at discrete cortical areas of interest and can avoid areas of the brain that are not relevant for its therapeutic actions.

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

• Mobile Console for housing the electronics and includes a software . controlled graphical user interface, display monitor, display arm, and gantry that supports the treatment coil.
• Ferromagnetic Coil for delivering treatment. .
• . Head Support System for positioning the treatment coil and includes a laser-guided alignment system
• . Optional MT Cap for
• Multi-use consumable SenStar Treatment Link for contact sensing of the ● treatment coil with the patient's head and maqnetic field quality control.
• TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software

Here's a breakdown of the acceptance criteria and study information for the NeuroStar Advanced Therapy System, based on the provided FDA 510(k) summary:

The primary purpose of this 510(k) submission is for the addition of the MT Cap accessory. The document explicitly states that the NeuroStar Advanced Therapy System (the subject device) has the same indications for use and technological characteristics as the predicate device, implying that the core system's performance metrics have already been established in previous submissions. This K213543 submission focuses on the safety and effectiveness of the new accessory.

Therefore, the "acceptance criteria" and "device performance" in the context of this specific submission revolve around demonstrating that the MT Cap accessory does not negatively impact the existing performance or introduce new risks, and that it functions as intended to aid in the Motor Threshold Hunt process.

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is an update for an accessory (MT Cap) to an already cleared device, the acceptance criteria are focused on demonstrating that the accessory does not compromise the device's safety or efficacy. The document does not provide specific quantitative performance metrics tied to sensitivity, specificity, accuracy, or similar measures typically found in standalone diagnostic AI/ML device acceptances. Instead, the "performance" demonstrated is compliance with relevant standards and successful usability.

Study Information Specific to the MT Cap Accessory

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

   • The document states, "There is no clinical testing required to support this submission."
   • For Usability testing, the sample size is not explicitly stated in the provided text. Usability studies typically involve a small number of representative users (e.g., 8-15) as per human factors guidance, but the exact number is not here.
   • The provenance for usability testing would typically be prospective, involving healthcare professionals interacting with the device/accessory. The document does not specify country of origin for usability test participants.

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

   • As no clinical testing was required, there was no "ground truth" to establish in the traditional sense of disease diagnosis or outcome for the MT Cap.
   • For usability testing, "experts" would be the healthcare professionals participating in the test. Their qualifications would typically involve experience with TMS procedures. The document does not specify the number or detailed qualifications of these individuals.

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

   • Not applicable as there was no clinical study with a diagnostic endpoint requiring adjudication. Usability studies use qualitative and quantitative measures of user performance, error rates, and satisfaction rather than adjudication of findings.

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 or comparative effectiveness study was done. This device is a hardware accessory (MT Cap) for a TMS system, not an AI/ML diagnostic or assistive algorithm. The MT Cap is a physical guide to assist in a manual process (Motor Threshold Hunt), not an AI.

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

   • Not applicable. The MT Cap is a passive physical accessory, not an algorithm.

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

   • Not applicable for the MT Cap accessory. For the overall NeuroStar system (established in prior submissions), ground truth for Major Depressive Disorder (MDD) efficacy would have been based on clinical assessments (e.g., Hamilton Depression Rating Scale, Montgomery-Åsberg Depression Rating Scale) and clinical outcomes, but this is not part of this submission.

7. The sample size for the training set:

   • Not applicable as this is not an AI/ML device requiring a training set.

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

   • Not applicable as this is not an AI/ML device requiring a training set.

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The NeuroStar TMS Therapy System 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 NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec nominal) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.

The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers NeuroStar TMS Therapy®. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. The SenStar Connect is a non-sterile, multi-use consumable which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment and provides surface field cancellation to reduce stimulation of the scalp. The TMS TrakStar™ practice data management system consists of a standalone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.

The provided text is a 510(k) summary for the NeuroStar® TMS Therapy System. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, specifically in the context of clinical performance or diagnostic accuracy relevant to AI/algorithm performance.

The document primarily focuses on engineering and performance specifications related to the physical function of the TMS device and its safety (electrical safety, EMC). It highlights that the 3.0 version of the device has "enhanced thermal performance," "improved ergonomics and reliability," and "improved user work flow" compared to the predicate device.

Therefore, I cannot fulfill the request as it asks for information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) that is not present in the provided text. The text does not describe an AI/algorithmic medical device in the way implied by the questions regarding acceptance criteria for clinical performance, ground truth, expert consensus, or comparative effectiveness studies with human readers.

The available information is limited to:

• Device Performance Specifications Table: This table compares physical and operational characteristics of the device (like treatment level range, pulses per second, coil type, etc.) between the predicate and the new device. These are engineering specifications, not clinical performance metrics related to diagnostic accuracy.
• Bench Performance Testing: This section lists tests performed to demonstrate the substantial equivalence of the new device to the predicate in terms of physical characteristics (magnetic field mapping, coil positioning accuracy) and safety (electrical safety, EMC). It explicitly states that "Verification and validation testing demonstrated that the changes to NeuroStar 3.0 do not substantially modify the performance of the device," implying the performance remains similar to the predicate.

To answer your specific questions, I would need a different type of document, such as a clinical study report or a 510(k) summary that details the clinical performance and validation of an AI-driven medical device.

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The NeuroStar TMS Therapy System 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 NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec nominal) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.

The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers NeuroStar TMS Therapy®. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. The SenStar® Connect is a non-sterile, multi-use consumable which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment and provides surface field cancellation to reduce stimulation of the scalp. The TMS TrakStar™ practice data management system consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.

The provided text describes a 510(k) premarket notification for the NeuroStar TMS Therapy System, focusing on a labeling modification to allow for a shorter treatment time by varying inter-train intervals. This is not a typical device performance study with acceptance criteria for diagnostic accuracy, but rather an assessment of safety and effectiveness equivalence with a predicate device under modified usage parameters.

Therefore, a table of acceptance criteria and reported device performance in the conventional sense (e.g., sensitivity, specificity) is not directly applicable. Instead, the study aims to demonstrate that a change in inter-train interval does not negatively impact the safety and efficacy of the device, which was already established for the predicate.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a labeling change based on equivalence, there aren't explicit numeric acceptance criteria like those for diagnostic devices (e.g., minimum sensitivity of 90%). The acceptance criteria essentially revolve around demonstrating non-inferiority in safety and efficacy with the modified inter-train interval compared to the established performance of the predicate device.

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

The "test set" here refers to the data used for the clinical performance assessment.

• Sample Size:

  • Effectiveness (Efficacy) Analysis: 44 studies (total of 50 active treatment arms) with complete information identified the TMS treatment parameter set and clinical outcome for the primary efficacy measure.
  • Safety Analysis: 61 studies (comprising 67 active treatment arms) among 2836 subjects provided adverse event data.
  • Within these, 11 clinical studies utilized the NeuroStar TMS Therapy System or progenitor iron-core devices, encompassing 1069 subjects, of whom 770 subjects received active TMS. The remaining studies used reference TMS devices.
  • The overall database search identified 79 studies and research outcomes on 3359 subjects, among whom 2162 subjects were exposed to active TMS treatment.

• Data Provenance: The studies were identified via a "database search" to identify "human studies evaluating TMS and variations in inter-train interval." This indicates the data is likely retrospective, drawing from published clinical trials and literature. The country of origin of the data is not specified but would presumably be diverse given the nature of a database search for TMS studies.

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

This type of information is not provided in the document. The study relies on clinical outcomes and reported adverse events from historical clinical trials, rather than forming a new "test set" with a panel of experts. The "ground truth" for efficacy would be the reported clinical outcomes (e.g., reduction in depression symptoms) in the included studies, and for safety, the reported adverse events. This ground truth was established by the original researchers and clinicians involved in those 79 studies.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the study is a retrospective review of existing literature and clinical trial data, it's unlikely that a new, external adjudication method was applied to the outcomes of those historical studies. The outcomes were presumably adjudicated by the methods employed within each individual study.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a treatment system (Transcranial Magnetic Stimulator) and not an AI-powered diagnostic device that involves human "readers" interpreting medical cases. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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 NeuroStar TMS Therapy System is a physical medical device for treatment, not an algorithm, and it operates with human supervision ("under the supervision of a licensed physician").

7. The Type of Ground Truth Used

The ground truth used in this study (a literature review) is based on:

• Clinical Outcomes/Efficacy Data: Reported improvement in Major Depressive Disorder (MDD) symptoms from the primary efficacy measures in the analyzed clinical trials.
• Adverse Event Data: Verbatim adverse event terms reported in the reference studies, including the incidence of seizure.

This is essentially outcomes data and reported clinical findings from a large body of pre-existing scientific literature.

8. The Sample Size for the Training Set

This information is not applicable. The study described is a review of existing clinical data to support a labeling change for an already cleared device, not an AI or algorithm development study that would involve a distinct "training set" in the context of machine learning. The device itself was developed and cleared based on its own clinical trials in the past.

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

This information is not applicable for the reasons stated in point 8.

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The NeuroStar TMS Therapy System 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 NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec (nominal)) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.

The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS Therapy™. The Head Support System provides accurate positioning of the Treatment Coil using a laserguided alignment system. A single-use device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient. The TMS TrakStar™ practice data management system consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.

Here's an analysis of the NeuroStar TMS Therapy System based on the provided text, focusing on acceptance criteria and the study proving its effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance thresholds for the device. Instead, it focuses on demonstrating statistically significant advantage and moderate to large treatment effects compared to a sham control. The primary outcome measure (remission rate) and secondary continuous outcomes (change scores) serve as the de-facto performance metrics.

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

• Sample Size (Test Set): N=197 adult patients.
  • Active TMS: N=97
  • Sham TMS: N=100
• Data Provenance: The study was a "multi-site" trial, implying data from various clinical sites. The document doesn't specify the country of origin, but given the FDA submission context, it's highly likely to be U.S.-based or a multi-national trial including U.S. sites. The study is described as a prospective, randomized, controlled trial (OPT-TMS RCT).

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

The ground truth was established by clinical assessment using standardized scales (HAMD24, MADRS, CGI-S, IDS-SR) conducted by "clinical personnel" at the various study sites. The document does not specify the "number of experts" or the "qualifications of those experts" (e.g., radiologist with 10 years of experience) in the way one might for diagnostic image interpretation. Instead, clinical scales are inherently designed for trained clinicians to apply. The HAMD24, for instance, is a clinician-rated scale.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the HAMD24 or other clinical scores. It implies that these scores were assessed and recorded by the clinical teams at each site as part of the standard protocol. The primary outcome, remission, was defined based on HAMD24 scores, which would have been directly observed from the assessments.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The NeuroStar TMS Therapy System is a therapeutic device, and its effectiveness was evaluated through a randomized controlled trial comparing active treatment to sham.

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

Yes, in a way. The "device" (NeuroStar TMS Therapy System) was tested in a standalone therapeutic capacity, meaning its effect was directly observed in the randomized controlled trial. While human operators are involved in administering the therapy, the study aimed to measure the therapeutic effect of the device itself compared to a sham device, not to assess an AI's diagnostic performance in an "algorithm-only" or "human-in-the-loop" scenario. The performance metrics (remission rates, change in symptom scores) directly reflect the device's therapeutic output.

7. Type of Ground Truth Used

The ground truth was based on clinical assessment using standardized, validated psychiatric rating scales. Specifically:

• HAMD24 (24-item Hamilton Depression Rating Scale): Primary measure for remission and change. Remission was defined as HAMD24 total score <3 or 2 consecutive ratings of HAMD24 total score <10.
• MADRS (Montgomery-Åsberg Depression Rating Scale)
• CGI-S (Clinical Global Impression – Severity scale)
• IDS-SR (Inventory of Depressive Symptomatology – Self-Report)

These scales serve as the expert consensus-driven, validated measures of depression severity and response to treatment.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an AI/machine learning algorithm. The NeuroStar TMS Therapy System is described as a computerized, electromechanical medical device that produces magnetic stimulation. It's a therapeutic device, not an AI diagnostic tool that would typically have a "training set" for model development. The clinical study (OPT-TMS RCT) is a validation study demonstrating the device's efficacy, not a study to train an algorithm.

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

Since there is no mention of an AI/machine learning component requiring a "training set," this question is not applicable to the information provided about the NeuroStar TMS Therapy System.

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The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 µsec) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS.
The NeuroStar TMS System is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar TMS System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
The NeuroStar TMS System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS TherapyTM. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. A singleuse device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient to patient. The TMS TrakStar (previously known as Practice Data Management System - PDMS) consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.

This 510(k) summary (K130233) describes a labeling change to the NeuroStar TMS Therapy System, not a new device requiring performance data. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance is not applicable to this submission.

Here's a breakdown of the relevant information provided and why other sections are not applicable:

1. A table of acceptance criteria and the reported device performance
   Not applicable. This 510(k) is for a labeling change to an already cleared device (K061053/K083538). No new performance data or acceptance criteria were required for this specific submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   Not applicable. No new test set data was generated or required for this labeling change.

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 establishment was needed for a labeling change.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. No 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 device is a transcranial magnetic stimulator for treatment, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This device is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   Not applicable.

8. The sample size for the training set
   Not applicable. This 510(k) is not for an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established
   Not applicable.

Summary of the K130233 Submission:

• Device: NeuroStar® TMS Therapy System
• Submission Type: 510(k) for a labeling change.
• Predicate Device: NeuroStar TMS Therapy® System [K061053/K083538]
• Reason for 510(k): To update the prescribing statement in the labeling to comply with the FDA's Class II Special Controls Guidance for Repetitive Transcranial Magnetic Stimulation (rTMS) Devices (26 July 2011).
• Conclusion: The FDA determined the device with the proposed labeling change is substantially equivalent to the predicate device, as no other changes were made to the device or its intended use. The substantial equivalence was based on similarities in indications for use, principles of operation, design for delivery of TMS, materials, shelf life, and packaging.

Ask a specific question about this device

The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

The NeuroStar TMS System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 usec) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. The peak magnetic field strength achieved with each pulse is approximately 1.5 Tesla.

The NeuroStar TMS System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, mechanically supports the ferromagnetic Treatment Coil and includes a software controlled graphical user interface, a ferromagnetic Treatment Coil to deliver TMS Therapy, a Head Support System for accurate coil positioning, and a single use device (SenStar® Treatment Link) placed on the face of the coil to reduce local scalp stimulation, to provide feedback to the operator regarding contact of the coil with the patient's head, and to verify the applied field strength. A separate Practice Data Management System (PDMS) allows and facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS System units.

Here's an analysis of the provided text regarding the Neurometnics NeuroStar TMS Therapy System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on a 510(k) summary for a modification to an existing device (adding a Class 1 laser positioning aid). As such, it primarily discusses the equivalence of the modified device to the predicate device, rather than establishing de novo acceptance criteria for the core therapeutic efficacy of TMS for Major Depressive Disorder. The core efficacy would have been established during the predicate device's clearance (K061053).

However, specific acceptance criteria for the new feature (the Class 1 laser positioning aid) were mentioned.

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

The document does not explicitly state the numerical sample sizes for the test sets in the context of the laser positioning aid. It refers to "design verification tests" and "performance testing."

• Test Set Sample Size: Not specified quantitatively.
• Data Provenance: The studies mentioned ("Test Report 80-80095-001" and "Test Report 80-80095-000") are internal verification and validation studies conducted by Neuronetics, Inc. The country of origin for the data is implicitly the United States, given the company's location and FDA submission. The studies are prospective in nature, as they are verification and validation tests for a new design feature.

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

This information is not provided in the summary. The types of tests described (accuracy of positioning, equivalence in MT determination) suggest a technical evaluation rather than a clinical expert panel review for the laser component.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned for this 510(k) submission. This submission is for a device modification (adding a laser positioning aid) to a previously cleared device. The focus is on demonstrating that the new feature maintains the established safety and effectiveness, not on a new comparative effectiveness study of the TMS therapy itself. Therefore, no effect size of human reader improvement with/without AI assistance is relevant here.

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

This device, the NeuroStar TMS Therapy System, is a medical device for treatment, not an AI or algorithm-only diagnostic tool. The "Class 1 laser positioning aid" is a hardware component with integrated circuitry and software to facilitate human operation; it is not a standalone algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this device or its new feature.

7. The Type of Ground Truth Used

For the laser positioning aid's performance, the ground truth would be based on:

• Design Specifications: For accuracy (e.g., how precisely the laser indicates a position compared to mechanical measurements or engineering requirements).
• Established Methods: For equivalence in Motor Threshold (MT) determination and TMS treatment locations. This implies comparison against the results obtained using the predicate device's existing positioning method.

8. The Sample Size for the Training Set

This information is not provided. The laser positioning aid involves embedded software and control logic, but the document does not describe it in terms of a "training set" in the machine learning context. It refers to design verification and validation, which typically involves testing against specifications and comparison to an existing standard.

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

As no "training set" in the machine learning sense is explicitly described, this question is not directly applicable. For the engineering verification of the laser positioning aid, the "ground truth" would be the predefined engineering specifications and criteria for accuracy and equivalence, which are established during the device design and development process.

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