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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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(176 days)
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.
| Acceptance Criteria Category (Derived from Equivalence Argument) | Reported Device Performance (Nexstim NBT System 2 - Proposed Device) | Discussion/Proof of Meeting Criteria |
|---|---|---|
| Magnetic Field Intensity | 120% of MT | Same as predicate (K173620) and previously cleared device (K171902). |
| 10Hz Treatment Parameters (Frequency, Train Duration, Inter-train Interval, Number of Trains, Max Pulses/Session, Session Duration, Sessions/Week, Treatment Schedule) | Aligned with predicate characteristics and FDA-cleared minor protocol changes for other equivalent devices. | "The Nexstim NBT System 2 is technologically equivalent to the MagVita TMS Therapy System as demonstrated in 510(k) submission K171902/S001, pages 4818-4822." |
| iTBS Treatment Parameters (Magnetic Field Intensity, Frequency, Train Duration, Inter-train Interval, Burst Pulses, Number of Trains, Max Pulses/Session, Session Duration) | Aligned with K173620, ensuring consistent stimulus intensity within bursts. | "The iTBS protocol was cleared by FDA in the Mag Vita TMS Therapy System w/ Theta Burst Stimulation 510(k) submission K173620 for Tonica Electrnik A/S. The Nexstim NBT System 2 is technologically equivalent to the MagVita TMS Therapy System as demonstrated in 510(k) submission K171902/S001, pages 4818-4822." |
| Protocols | Standard 10 Hz and iTBS | Same as K173620 for both protocols. 10 Hz was already cleared in K171902. |
| Area of Brain to be Stimulated | DLPFC (Dorsolateral Prefrontal Cortex) | Same as predicate and previously cleared device. |
| Coil Material | Copper winding with air core | Same as predicate and previously cleared device. No change from coil cleared in K171902. |
| Coil Windings | 72 mm, 10 turns/wing | Same as predicate and previously cleared device. Same coil as cleared in K171902. |
| Amplitude Range | 0 to 2.5 SMT | Same as previously cleared device. No change from that cleared in K171902. |
| Pulse Length | 230 µs ± 5 µsec | Same as previously cleared device. No change from that cleared in K171902. |
| Frequency Range | 0.1 - 50 Hz (includes iTBS frequency of 50 Hz) | No change from range cleared in K171902. |
| Coil Positioning Principle | Individual patient direct targeting of anatomical treatment location (DLPFC) using 3D MRI model | Same as previously cleared device. No change from that cleared in K171902. Differs from predicate which uses indirect targeting. However, this is already an established feature of the Nexstim NBT System (cleared in K171902). |
| MT Response Detection | EMG provides qualitative and quantitative data based on which user defines MT. | Same as previously cleared device. No change from that cleared in K171902. (Predicate uses visual qualitative monitoring). |
| Sterilization & Shelf Life | Not shipped sterile. NBT Head Tracker: 2 years. Focal/Cooled Coils: 2M pulses or 2 years. | Verified through testing. |
| Biocompatibility | Complies with ISO 10993-1:2009. | Determined safe for patient contact. |
| Software Verification & Validation | Rigorously verified and validated per internal process and FDA/IEC standards (e.g., FDA guidance for software, IEC 62304). | Test results indicate compliance with predetermined specifications and standards. |
| Electrical Safety | Complies with IEC 60601-1:2005, Am1:2012 and ANSI/AAMI ES 60601-1:2005, Am2:2010. | Test results indicate compliance with standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2007 and FCC 47 CFR §15. | Test results indicate compliance with standards. |
| Bench Verification (Performance Testing) | Complies with internal documentation and FDA Guidance for rTMS systems. | Test results indicate compliance with predetermined specification and applicable standard. |
| Usability Validation | Complies with IEC 60601-1-6:2010 and IEC 62366:2007. | Test results indicate compliance with applicable standards. |
Study Details:
-
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.
-
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).
-
Adjudication Method for the Test Set:
- Not applicable. No external "test set" requiring expert adjudication is described.
-
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.
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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.
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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.
- The "ground truth" for this submission is multi-faceted, aligning with the nature of a therapeutic device and a substantial equivalence review:
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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."
-
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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(101 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 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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