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510(k) Data Aggregation
(266 days)
NeuroStar Advanced Therapy System (All previously cleared models)
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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(30 days)
NeuroStar Advanced Therapy System (Version 3.8)
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 intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical 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 Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console
- System Software
- Treatment Chair
- Ferromagnetic Treatment Coil
- Head Support System or Headrest
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- MDD MT Cap and OCD MT Cap
- TrakStar™ Patient Data Management System
- D-Tect™ MT Accessory
- NeuroSITE
The provided document is a 510(k) summary for the NeuroStar Advanced Therapy System (Version 3.8). This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing clinical study results or acceptance criteria in the comprehensive manner typically found in a clinical study report for an AI/ML device.
However, based on the information provided, we can infer some details relevant to your request, specifically concerning the engineering and human factors testing which serves as the "study" proving the device meets performance criteria, even if not phrased as traditional "acceptance criteria" for an AI/ML algorithm's clinical performance.
Here's an attempt to answer your questions based on the available text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the performance of the new software features, nor does it present device performance in a table with specific metrics. Instead, it states a qualitative conclusion:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Successful recording, saving, and displaying of patient's MT and treatment locations by NeuroSITE and Headrest (equivalent to current Head Support System). | "the results of verification and validation testing confirmed that the NeuroSITE and Headrest can successfully be used with the NeuroStar System software to record, save, and display the patient's MT and treatment locations in a manner that is equivalent to the current Head Support System." |
| Treatment location equivalence between new components (NeuroSITE/Headrest) and current Head Support System. | "Engineering and Human Factors testing had demonstrated that the treatment location is equivalent whether using the Head Support System or the NeuroSITE" (stated for both MDD and OCD indications). |
| Clinical outcomes will be the same with new components. | "and clinical outcomes will be the same" (stated for both MDD and OCD indications, though this is a prediction based on location equivalence, not a direct clinical outcome measure from this specific submission's testing). |
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 mentions "verification and validation testing" and "Engineering and Human Factors testing." It does not specify the sample size (e.g., number of uses, number of subjects for human factors) used for these tests. It also does not provide details on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full test reports, which are summarized in the 510(k).
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)
The document does not provide information on the number or qualifications of experts used to establish "ground truth" for the engineering and human factors testing. Given the nature of the change (replacement of physical components for coil positioning), the ground truth for "treatment location equivalence" would likely be based on physical measurements and possibly user observations in human factors studies, rather than expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. This type of process is common in image interpretation studies or clinical trials where subjective assessments are made by multiple readers. For engineering and human factors testing of device mechanics and software functionality, adjudication in this sense is typically not applicable.
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 MRMC comparative effectiveness study was done or mentioned. This submission is for a modification to a Transcranial Magnetic Stimulation (TMS) system, specifically regarding mechanical components and software for coil positioning, not an AI-assisted diagnostic or interpretative device that would typically undergo an MRMC study. The device itself is a treatment device, not primarily an AI-driven interpretive one in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not detail separate standalone algorithm performance. The software change (version 3.8) is explicitly linked to the physical components (NeuroSITE and Headrest) for recording, saving, and displaying patient MT and treatment locations. The testing confirmed the system's ability (software with new hardware) to achieve equivalence, implying an integrated performance evaluation rather than a standalone algorithm assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document doesn't explicitly state the "type of ground truth." However, based on the context of the device modification (coil positioning), the ground truth for "treatment location equivalence" would most likely be established through:
- Engineering measurements: Precise physical measurements of coil placement relative to anatomical landmarks.
- Human factors evaluation: Observation and measurement of user interaction and accuracy in achieving desired coil positions by operators, potentially against a pre-defined target or the performance of the predicate system.
- Absence of new risks: The document emphasizes that the change "does not introduce any new risks" and that "clinical outcomes will be the same," implying that the ground truth for safety and effectiveness is tied to maintaining the established performance of the predicate device.
8. The sample size for the training set
The document does not mention a training set, as this submission is for a hardware and software update to an existing device, not the development or retraining of a new AI/ML algorithm where large training datasets are typically disclosed. The software updates are likely based on engineering design and software development best practices, rather than AI model training.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of AI/ML, this question is not applicable to the information provided. The "ground truth" for the software's functionality would have been established through software requirements, design specifications, and subsequent verification and validation testing against these pre-defined expectations.
Summary of what the document focuses on regarding "proof":
The core of the "proof" in this 510(k) submission, regarding the software and hardware changes, is the demonstration through non-clinical testing (engineering and human factors) that the new components perform equivalently to the existing ones in terms of their intended functions, specifically "recording, saving, and displaying the patient's MT and treatment locations" and achieving "treatment location equivalence." The conclusion is that these changes do not introduce new questions of safety or effectiveness. This is a common approach for minor device modifications where clinical performance has already been established by the predicate device.
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(90 days)
NeuroStar Advanced Therapy System (Version 3.7)
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 intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical 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 Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console
- System Software
- Treatment Chair
- Ferromagnetic Treatment Coil
- Head Support System
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- MT Cap
- TrakStar™ Patient Data Management System
- D-Tect™ MT Accessory
- Beam F3 Treatment Pack
There are two proposed changes to the NeuroStar Advanced Therapy System that are the subject of this 510(k). The first proposed change introduces the capability to use wireless communication to transfer data between the NeuroStar System software and the TrakStar Patient Data Management System, as an alternative to using an ethernet cable to facilitate this transfer. The second proposed change allows for the alternative use of the Beam F3 treatment location method (herein: "Beam F3 method"), in addition to the current method that utilizes a location 5 cm away from the motor threshold within the dorsolateral prefrontal cortex (DLPFC) reqion of the brain. The Beam F3 method requires measuring different skull dimensions and uses these values to calculate the F3 treatment location, which is also located within the DLPFC. This 510(k) introduces software embedded into the NeuroStar System that performs these calculations as well as single-use measuring accessories. Once the F3 treatment location is determined, the treatment parameters and protocols remain the same as those used in the currently marketed NeuroStar Advanced Therapy System.
This document does not contain an acceptance criteria table or a detailed study proving the device meets specific performance criteria through clinical testing. Instead, it is a 510(k) premarket notification summary from the FDA, asserting substantial equivalence to previously cleared predicate devices.
The key statement is on page 5: "Clinical Testing: There is no clinical testing required to support this submission."
Therefore, I cannot provide the full response as requested, as the necessary information regarding acceptance criteria, reported performance, test set details, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in the provided document.
The document focuses on demonstrating that the proposed changes (wireless communication and the Beam F3 treatment location method) to the NeuroStar Advanced Therapy System do not raise new questions of safety or effectiveness when compared to its predicate devices. The "Performance Standards" section lists recognized consensus standards (ISO 10993-1, ANSI AAMI ES60601-1 / IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6) and mentions non-clinical performance testing and usability testing were performed according to relevant guidance documents. However, this is related to safety and electrical performance, not clinical efficacy or device performance against specific metrics as would be found in a detailed clinical study report proving accuracy or effectiveness.
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(30 days)
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy
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 maqnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console .
- System Software .
- . Treatment Chair
- Ferromagnetic Treatment Coil
- . Head Support System
- SenStar® Connect Treatment Link & SenStar® Treatment Link ●
- . MT Cap
- TrakStar™ Patient Data Management System ●
- D-Tect™ MT Accessory ●
The proposed change to the NeuroStar Advanced Therapy System that is the subject of this 510(k) is the addition of the NeuroStar D-Tect™ MT Accessory, which is a non-sterile, multi-use device that provides an optional method to aid in the Motor Threshold (MT) hunt process. This device is used to provide indication and amplitude of hand movement during this process. The D-Tect™ MT Accessory includes a user display interface and a human hand interface with builtin sensors for measuring thumb and finger movements. The device is a standalone accessory that does not communicate or interact with the NeuroStar Advanced Therapy System, except for receiving pulse signals in order to sync data collection. Use of the device is optional, and provides an alternative, quantitative method to determine the MT compared to the standard of care, which includes a qualitative, visual assessment. The D-Tect™ MT Accessory is only used during the Motor Threshold (MT) determination process, which is only performed the first time a patient is seen by the doctor and is performed prior to the first treatment session.
This document describes a 510(k) premarket notification for the NeuroStar D-Tect™ MT Accessory, an addition to the NeuroStar Advanced Therapy System. The accessory is designed to aid in the Motor Threshold (MT) hunt process by providing an optional, quantitative method to determine the MT, as an alternative to the standard qualitative, visual assessment.
Acceptance Criteria and Device Performance:
The document does not specify quantified acceptance criteria or reported device performance metrics in the format of a table for the D-Tect™ MT Accessory itself. Instead, it relies on demonstrating that the D-Tect™ MT Accessory does not introduce new questions of safety or effectiveness and that the overall NeuroStar Advanced Therapy System, with the addition of this accessory, continues to conform to established performance standards.
The closest information related to performance is the statement that the device provides an "indication and amplitude of hand movement" during the MT hunt process.
Study Information:
The document explicitly states: "There is no clinical testing required to support this submission."
Therefore, the following points associated with clinical studies are not applicable or provided:
- Sample size used for the test set and the data provenance: Not applicable as no clinical testing was performed for this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical testing was performed for this submission.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical testing was performed for this submission.
- 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 device is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical testing was performed for this submission. The D-Tect™ MT Accessory is a physical device that provides quantitative data to aid a human operator, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical testing was performed for this submission.
- The sample size for the training set: Not applicable as no clinical testing was performed for this submission.
- How the ground truth for the training set was established: Not applicable as no clinical testing was performed for this submission.
Non-clinical Testing:
The device's acceptance is primarily based on non-clinical performance and usability testing. These tests conform to the following recognized consensus standards:
- ISO 10993-1
- ANSI AAMI ES60601-1
- IEC 60601-1-2
- IEC 60601-1-6
Additionally, usability testing was completed in accordance with IEC 60601-1-6 Edition 3.1 2013-10 and the FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices."
The overarching conclusion is that the addition of the D-Tect™ MT Accessory, while providing an optional quantitative method for MT determination, does not alter the fundamental safety or effectiveness of the NeuroStar Advanced Therapy System, which has existing regulatory clearances (predicate devices listed: K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127). The accessory's function is to aid in a process, not to independently make diagnostic or treatment decisions.
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(178 days)
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy
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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(289 days)
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar
TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure. The system consists of: 1. Mobile console 2. System software with GUI 3. Treatment chair 4. Head support system 5. Coil positioning system 6. Same Coil for both MT and treatment 7. Coil fixture 8. Data management system.
The provided text describes the regulatory clearance for the NeuroStar Advanced Therapy System for the
adjunctive treatment of Obsessive-Compulsive Disorder (OCD). The submission is a 510(k) premarket
notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, the study design focuses on proving equivalence rather than meeting pre-defined acceptance
criteria based on clinical efficacy outcomes or standalone algorithm performance.
Here's the breakdown of information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are
primarily focused on demonstrating that the device's technological characteristics, safety, and
performance are equivalent to a predicate device. There aren't traditional clinical efficacy
acceptance criteria (e.g., a specific percentage improvement in OCD symptoms) as would be seen in a
PMA or a clinical trial designed to establish de novo efficacy.
The "acceptance criteria" are therefore implicit in the comparison to the predicate device and the
adherence to recognized standards.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Magnetic and Electric Field Properties Substantially Equivalent to Predicate Device (MagVenture Cool D-B80 coil) (based on Section 4 of FDA's Class II Special Controls Guidance) | Magnetic Field Distribution: Measurements determined that the magnetic spatial distribution is substantially equivalent to the Cool D-B80 coil. Both coils are figure 8 designs, allowing for deep and broad stimulation of the cortex. Information about linearity of output level, magnetic field strength gradients, output waveform, and magnetic field spatial distribution was provided. |
| Electric Field Distribution: Measurements determined that the linearity of the electric field output and the electric field spatial distributions are substantially equivalent to the Cool D-B80 coil. | |
| Overall: Performance testing confirmed equivalence in safety and performance based on electric field distribution, stimulation volume, magnetic field distribution, and magnetic flux, pulse timing. No new safety or effectiveness issues introduced. | |
| Safety - Sound Pressure Levels (in accordance with IEC60601 Edition 3.1) | Complies with specified permissible sound pressure levels and permissible thresholds for exposure defined by OSHA. Provides evidence that the system does not pose any risk for potential hearing reduction or loss in either patients or operators. |
| Conformity to Performance Standards (ISO 13485:2016, IEC60601-1, IEC60601-1-2) | Successfully tested and conforms to ISO 13485:2016, IEC60601-1 Ed. 3.1, and IEC60601-1-2:2014. |
| Software Verification and Validation | Performed. Subject device functions as intended and meets the same acceptance as the primary predicate and predicate devices. |
| Non-Clinical Performance Testing for Special Controls (per 21 CFRH 882.5802) | Performed as required. |
| Intended Use and Stimulation Parameters Equivalent to Primary Predicate Device (MagVenture TMS Therapy System - K193006) for OCD treatment (specifically regarding intensity, repetition rate, train duration, inter-train-interval, number of trains, pulses, total duration, and treatment area). | The intended use for OCD is identical. The treatment parameters (intensity, repetition rate, train duration, inter-train-interval, number of trains, pulses, total duration, and treatment area - Dorsomedial Prefrontal Cortex) are reported as having "No Difference" compared to the primary predicate. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "This 510(k) does not contain any pivotal clinical trial data related
to the new device. The substantial equivalency is established based on similar technological
characteristics." Therefore, there is no clinical "test set" in the traditional sense of patient
data for efficacy. The "test set" here refers to bench testing data comparing the subject device's
physical characteristics to the predicate device. The provenance of this bench testing data is not
specified (e.g., where the tests were physically conducted), but it refers to well-established
scientific methods using standard scientific instrumentation. The specific sample sizes for these
bench tests (e.g., number of coils tested) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of
those experts
Not applicable. There was no clinical "test set" requiring expert ground truth in the context of this
510(k) submission, which relied on bench testing and comparison to a predicate.
4. Adjudication method for the test set
Not applicable, as there was no clinical "test set" or expert review process for patient outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the
effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Transcranial Magnetic Stimulation (TMS) system, not an AI or imaging
diagnostic device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for treatment, not an algorithm. The "device performance"
reported relates to its physical and functional characteristics (e.g., magnetic field, sound levels)
and adherence to safety standards, not an algorithm's standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" was established by measurements using well-established
scientific methods and standard scientific instrumentation, as referenced in Section 4 of the FDA's
Class II Special Controls Guidance document for rTMS systems. This involves physical measurements of
magnetic and electric fields.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML algorithm that undergoes
machine-learning training. The device's design and parameters are established through engineering and
medical principles, not statistical learning from data.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
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(32 days)
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility (for MT Cap) | MT Cap material compliant with ISO 10993-1:2018; uses standard materials commonly used in consumer products and medical device applications. |
| Usability (for MT Cap integration) | Usability testing completed in accordance with IEC 60601-1-6:2010, Edition 3.1 and FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices." The MT Cap enables physicians to easily move the coil incrementally without adjusting the A/P Bar. |
| Safety - Electrical/EMC (overall system) | IEC 60601-1 compliant; IEC 60601-1-2 compliant (inherited from predicate device, not re-evaluated for MT Cap specifically as it's a passive accessory). |
| No New Questions of Safety or Effectiveness | The use of the optional MT Cap accessory "does not raise any new questions of safety or effectiveness." This is the overarching acceptance. |
| Functional Aiding of MT Hunt | MT Cap provides symmetrical grid for incremental coil movement and includes intersecting lines for starting point; aids in facilitating the hunt for the MT location. |
| No change to core treatment parameters | All core treatment parameters (%MT Range, PPS Range, Induced Electric Field, Pulse Type, Pulse Width, Treatment Protocols, Treatment Level Range) remain identical to the predicate device. |
Study Information Specific to the MT Cap Accessory
-
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.
-
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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable as this is not an AI/ML device requiring a training set.
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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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(204 days)
NeuroStar Advanced Therapy
NeuroStar Advanced Therapy 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 Magnetic 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.
The proposed changes to the NeuroStar Advanced Therapy System described in this Traditional 510(k) Premarket Notification include the introduction of a new feature that allows the NeuroStar Advanced Therapy system to perform the TMS therapy known as intermittent theta burst stimulation (iTBS). NeuroBurst is the proprietary name for the iTBS treatment conducted by the NeuroStar Advanced Therapy System. The NeuroBurst treatment protocol consists of a burst of three (3) pulses at 50Hz with a 160ms interval between bursts. The protocol uses a train that consists of five (5) bursts per second for two (2) seconds with an eight (8) second interval between trains. A treatment session lasts for 20 trains or 3.3 minutes.
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.
- Multi-use consumable SenStar Treatment Link for contact sensing of the treatment coil with the patient's head and magnetic field quality control.
- TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software.
The provided text is a 510(k) summary for the NeuroStar Advanced Therapy System, primarily focusing on demonstrating substantial equivalence to a predicate device and introducing a new feature (iTBS treatment, or NeuroBurst). It lacks the specific details required to answer your questions about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.
The document describes a medical device (Transcranial Magnetic Stimulation System) for treating Major Depressive Disorder, not an AI/ML algorithm that predicts or diagnoses based on data. Therefore, the concepts of "test sets," "ground truth," "expert consensus," "MRMC studies," or "standalone algorithm performance" as typically applied to AI/ML device validation are not discussed.
The "performance data" mentioned here refers to:
- Physical performance of the device: magnetic field characteristics, output waveform, linear output level, electromagnetic compatibility (EMC), and electrical safety.
- Comparison to predicate/reference devices: demonstrating that the NeuroStar system's technological characteristics, indications for use, and principles of operation are substantially equivalent. The clinical effectiveness of iTBS itself is supported by the reference device's prior FDA clearance, not a new clinical study presented in this 510(k) summary for the NeuroStar device's NeuroBurst feature.
Therefore, I cannot extract the requested information as it is not present in the provided text.
To illustrate what kind of information would be needed to answer your questions, here's a hypothetical example relevant to an AI/ML device, assuming the NeuroStar was an AI/ML device (which it is not, based on this document):
Hypothetical Example (If NeuroStar were an AI/ML device):
Let's imagine the NeuroStar Advanced Therapy System had an AI component designed to predict patient response to TMS therapy based on patient characteristics and brain imaging data.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for AI component: Prediction of Treatment Response) | Reported Device Performance |
|---|---|
| Primary Endpoints: | |
| Area Under the Receiver Operating Characteristic Curve (AUC) ≥ 0.85 (for predicting "Responder" vs. "Non-Responder") | 0.88 |
| Sensitivity for "Responder" prediction ≥ 80% | 82% |
| Specificity for "Non-Responder" prediction ≥ 70% | 75% |
| Secondary Endpoints: | |
| Positive Predictive Value (PPV) ≥ 75% | 78% |
| Negative Predictive Value (NPV) ≥ 85% | 87% |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 500 patients
- Data Provenance:
- Country of Origin: Multi-center study including data from the United States (40%), United Kingdom (30%), and Canada (30%).
- Retrospective/Prospective: Data collected prospectively from an observational cohort study specifically designed for AI model validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 3 independent expert psychiatrists.
- Qualifications of Experts: Each psychiatrist had at least 15 years of clinical experience in treating Major Depressive Disorder and specialized in TMS therapy. They were board-certified in psychiatry in their respective countries.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: 3-reader consensus. If all three experts agreed on the patient's responder status (
responderornon-responder), that was taken as the ground truth. In cases of disagreement (e.g., 2 agree, 1 disagrees), a fourth, senior adjudicating psychiatrist (not involved in initial readings) reviewed the case and made the final determination.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Yes, an MRMC study was conducted.
- Effect Size:
- Without AI Assistance: Average AUC for human readers was 0.70 (95% CI: 0.68-0.72).
- With AI Assistance: Average AUC for human readers improved to 0.80 (95% CI: 0.78-0.82).
- Improvement (Effect Size): The AI assistance led to an average increase of 0.10 in AUC for human readers (p
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