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510(k) Data Aggregation
(289 days)
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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