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510(k) Data Aggregation
(266 days)
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).
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
- MT Cap
- . D-Tect MT Accessory
- TrakStar Data Management
The NeuroStar Advanced Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Success Criteria) | Reported Device Performance |
|---|---|
| A minimum of 50% of the primary per protocol analysis population meet the Individual Subject Success Criteria (defined as a meaningful reduction in depression symptoms based on PHQ-9 scores over a pre-post TMS treatment interval of 6 weeks and achieving remission of MDD symptoms). | 77.8% (95% CI: 72.8%, 83.0%) of the primary per protocol population met the criteria. |
| The lower limit of the 95% confidence interval for individual success rate should exceed the pre-established Overall Study Success Criteria of a minimum 50%. | The lower limit (72.8%) exceeded 50% by 22.79%. |
| Proportion of responders (defined as a meaningful reduction in depression symptoms based on PHQ-9 scores) is statistically significant. | This proportion was found to be statistically significant at p |
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(178 days)
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:
- Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Outcome Measures) | Reported NeuroStar Advanced Therapy System Performance |
|---|---|
| For Depression (Derived from Predicate Device Clearance, not explicitly detailed here for criteria beyond initial clearance) | O'Reardon et al., 2008 & George et al., 2010 (original clearance studies for MDD): |
| Response Rate (≥ 50% decrease in end score relative to baseline) for HAMD-17 and HAMD-24 | Statistically significant improvement (p |
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(137 days)
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 NBT® System 2 is a 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 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 (3-D) 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 through standard DICOM communication protocols, and generates an accurate 3-D model of the patient's head which can be "peeled back" to reveal the anatomical structures of the brain.
The provided text describes the Nexstim Navigated Brain Therapy (NBT) System 2, a repetitive transcranial magnetic stimulation (rTMS) system for treating Major Depressive Disorder. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or details of a study directly proving the device meets acceptance criteria in the format requested for AI/ML devices.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical trial results or performance metrics against pre-defined acceptance criteria typical for novel AI/ML device evaluations.
It primarily details:
- Device Description and Intended Use
- Technology Comparison with predicate devices (showing similar technical characteristics)
- Summary of Performance Testing related to general medical device standards (sterilization, biocompatibility, software verification, electrical safety, EMC, and usability).
There are two studies mentioned under "Performance Testing – Bench Verification," which relate to the device's methods for determining motor threshold (MT) and coil localization, comparing them to manually-determined methods. However, these are not presented as a "study that proves the device meets the acceptance criteria" in the context of clinical effectiveness or diagnostic accuracy, which is often what is implied by "acceptance criteria" and "reported device performance" for AI/ML enabled devices.
Given the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Study Details (Based on provided text)
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or device performance in the context of clinical efficacy or diagnostic accuracy in a table format. Instead, it refers to compliance with various medical device standards and internal specifications. The "Performance Testing - Bench Verification" section mentions two studies that compare specific aspects of the device's function (MT determination and coil localization) to other methods, suggesting "no significant statistical difference" or "substantially equivalent results" as outcomes for these functional aspects, which could be interpreted as meeting an implicit acceptance criterion of equivalence for these specific functions.
| Acceptance Criteria (Implied from Performance Testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials comply with ISO 10993-1. | Determined to be safe to use with patients. |
| Software: Complies with predetermined specifications and relevant FDA guidance (e.g., software development, cybersecurity), IEC 62304. | Software complies with its predetermined specifications, and the Standards and guidance documents. |
| Electrical Safety: Complies with IEC 60601-1, ANSI/AAMI ES 60601-1. | Nexstim NBT System 2 complies with the Standards. |
| Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2, FCC 47 CFR §15. | Nexstim NBT System 2 complies with the Standards. |
| Usability: Complies with IEC 60601-1-6, IEC 62366. | Nexstim NBT System 2 complies with the applicable Standards. |
| Motor Threshold (MT) Determination: Nexstim's Electromyography-Determined MT Method is comparable to Manually-Determined MT Method. (Study: O'Reardon, 2007; Pridmore, 1998) | Demonstrates no significant statistical difference between methods. |
| Navigated Coil Localization: Nexstim's method is comparable to Manually-Determined Method (moving the coil 5.5 cm anteriorly from the motor cortex). (Study: Ahdab, 2010) | Demonstrates substantially equivalent results between methods. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Study Comparing Nexstim's Electromyography-Determined Motor Threshold (MT) Method to the Manually-Determined MT Method (O'Reardon, 2007; Pridmore, 1998)" and "Study Comparing Nexstim's Navigated Coil Localization Method to Manually-Determined Method (Ahdab, 2010)".
- Sample Size: Not specified in the provided text for either study.
- Data Provenance: Not specified in the provided text for either study (e.g., country of origin, retrospective or prospective). The studies are referenced by author and year, suggesting they are published literature or internal studies referring to published methods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided text. For the MT and coil localization comparison studies, "manually-determined methods" serve as a reference, implying human expertise, but details are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified in the provided text.
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 Nexstim NBT System 2 is not an AI-assisted diagnostic device where "human readers" would be involved in interpreting data with or without AI. It is a therapeutic device (rTMS system). The listed comparative studies focus on functional aspects of the device (MT determination and coil localization) rather than comparative effectiveness studies in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the typical sense of standalone AI performance. The device is a system operated by a trained medical professional. The functional comparisons (MT determination, coil localization) are aspects of the system's operation that are being compared to manual methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the Motor Threshold (MT) determination, the ground truth appears to be established by a "manually-determined MT method" (implied expert determination, likely involving visual and/or manual assessment of muscle twitch).
- For the Navigated Coil Localization, the ground truth is a "manually-determined method (moving the coil 5.5 cm anteriorly from the motor cortex)," which is a standard anatomical targeting approach.
8. The sample size for the training set
Not applicable/specified. The document does not describe the device as an AI/ML system that undergoes "training." The software development process is mentioned, but without details on a training set for model development.
9. How the ground truth for the training set was established
Not applicable/specified, as there is no mention of an AI/ML "training set."
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(88 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by the study) |
|---|---|
| Safety: The risk of inadvertent seizure and the pattern of common adverse events with the modified inter-train interval must not systematically vary from established risks. | "This analysis showed that there is no evidence to indicate that the risk of inadvertent seizure or the pattern of common adverse events reported for TMS varies in a systematic manner across the range of inter-train intervals used within the reported treatment parameter sets." (Based on 61 studies, 67 active treatment arms, 2836 subjects) |
| Efficacy: TMS efficacy with the modified inter-train interval must not be negatively impacted. | "This analysis showed that variations across the range of inter-train intervals used within the reported treatment parameter sets do not impact TMS efficacy." (Based on 44 studies, 50 active treatment arms where complete information on TMS treatment parameters and clinical outcome for primary efficacy measure was available. This also included four peer-reviewed meta-analyses.) |
| Substantial Equivalence: The modified device (with labeling change) remains substantially equivalent to the predicate. | "The NeuroStar TMS Therapy System that is the subject of this premarket 510(k) notification is the same (substantially equivalent) device cleared by the FDA under DEN070003/K061053, K083538, K130233 and K133408." "New clinical data from a literature review... demonstrate that the revised inter-train interval range does not impact the safety and efficacy..." |
| Physiological Parameters: The change remains within existing product specifications. | "This change remains within the existing product specification for inter-train interval (range 10-60 seconds for > 1 pulse per second)." |
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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