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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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

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

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

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

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

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

• Sample Size:

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a treatment system (Transcranial Magnetic Stimulator) and not an AI-powered diagnostic device that involves human "readers" interpreting medical cases. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. The NeuroStar TMS Therapy System is a physical medical device for treatment, not an algorithm, and it operates with human supervision ("under the supervision of a licensed physician").

7. The Type of Ground Truth Used

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

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

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
   Not applicable. No ground truth establishment was needed for a labeling change.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. No test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
   Not applicable. This device is a transcranial magnetic stimulator for treatment, not an AI-assisted diagnostic tool.

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

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

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

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

Summary of the K130233 Submission:

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

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The Venus Freeze (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

The Venus Freeze (MP)2 is a noninvasive, non-ablative device consisting of:

• Main Unit (console)
• Touch Screen user interface
• RF Power module
• Controller unit
• Two treatment applicators:
  (1) Octipolar™ applicator - for large area treatments, composed of 8 RF electrodes, 8 electrode coils assembled over electrodes and 1 central coil (the RF is emitted through the electrodes. The PMF is generated by the coils).
  (2) Diamondpolar™ applicator - for small area treatments, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).
  Touch screen user interface provides:
• Applicator selection (Octipolar™ / Diamondpolar™)
• RF Power Output and Treatment Time parameter adjustments to fit individual patient's skin condition and anatomical site treated.
• Current treatment parameters display.
  The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

The provided text describes the Venus Freeze (MP)2 System, a non-invasive device for treating moderate to severe facial wrinkles and rhytides. While it mentions regulatory compliance and a clinical study, it does not provide detailed acceptance criteria or the comprehensive study breakdown as requested.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for this table:

• Specific, quantitative acceptance criteria for effectiveness. For example, a percentage reduction in wrinkle severity as measured by a specific scale, or a certain percentage of patients achieving a predefined improvement. The document only states "clearly indicate" effectiveness without defining measurable criteria.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not explicitly stated. The document refers to "Patients were treated with the Venus Freeze (MP)2 System for face wrinkle reduction" but does not give a number for the study population.
• Data provenance: Not explicitly stated. It's a clinical study conducted to support a 510(k) submission, suggesting it's prospective, but the geographical origin of the data (country) is not mentioned.

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

• This information is not provided. The document makes no mention of expert evaluation, subjective grading, or the qualifications of any such experts.

4. Adjudication method for the test set

• This information is not provided. Given the lack of expert involvement details, adjudication methods are not discussed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is an aesthetic medical device, not an AI-powered diagnostic tool, so such a study would not be applicable. The text describes a system that uses RF and PMF technology directly on patients, not an AI that assists human readers.

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

• Not applicable. This is a medical device for direct patient treatment, not an algorithm, so "standalone performance" in the context of an algorithm is irrelevant.

7. The type of ground truth used

• The "ground truth" for the device's effectiveness appears to be based on clinical observation of wrinkle reduction and the absence of unexpected adverse side effects. However, the specific method of measuring wrinkle reduction (e.g., a standardized scale, physician assessment, patient satisfaction) is not detailed.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that undergoes training. It's a hardware device with specific energy delivery mechanisms.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

In summary:

The provided 510(k) summary focuses on the device description, intended use, predicate devices, and general safety and regulatory compliance. While it mentions a clinical study to demonstrate effectiveness ("face wrinkle reduction") and safety, it lacks the granular detail requested for acceptance criteria, study design (especially sample sizes and expert involvement for ground truth), and performance metrics typically found in efficacy studies for AI or diagnostic devices. The closest the document comes to performance is the statement that "No unexpected adverse side effects were detected or reported" and that the data "clearly indicate" effectiveness, but without quantitative measures or specific acceptance thresholds for that effectiveness.

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