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Horizon 3.0 TMS 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 have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Horizon® 3.0 TMS 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").

The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons 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 have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.

The provided text is a 510(k) summary for the Magstim Horizon 3.0 TMS Therapy System. It states that the device is substantially equivalent to a predicate device and does not involve clinical data from a new study. Therefore, the information typically requested regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance for a new study validating the device's performance against acceptance criteria is not present. Instead, the submission relies on demonstrating equivalence to previously cleared devices based on technological characteristics and existing clinical evidence for those predicates.

However, I can extract and format information regarding the basis for this substantial equivalence claim, particularly focusing on the non-clinical testing performed to show equivalence of the magnetic and electric fields, which serves as a proxy for meeting performance criteria for the extended indication.

Here's a breakdown of the information that can be extracted, and where the requested details are not applicable or provided:

1. A table of acceptance criteria and the reported device performance

The submission does not present a formal "acceptance criteria table" with numerical thresholds directly met by the subject device's performance. Instead, the performance is demonstrated by showing "equivalence" to a predicate device. The key performance metrics discussed are related to magnetic and electrical field characteristics.

Table: Comparative Performance Criteria (demonstrated by equivalence to predicate)

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

• Non-clinical Testing:
  • Sample Size for Magnetic/Electric Field Comparative Testing: Not specified in terms of "samples." This involves physical measurements and computational modeling of the devices themselves rather than a dataset of patient outcomes.
  • Data Provenance: The testing was conducted by Magstim and involved direct comparison of their device (Horizon 3.0) with the predicate (NeuroStar Advanced Therapy System). No country of origin for a data set is specified as it's not a patient-based study. This was primary testing to support the submission (prospective, in a sense, as it was done for the 510(k)).
• Clinical Data (referenced for equivalence, not a new study): The submission explicitly states, "No new clinical data is being leveraged for this 510(k) submission." Instead, it relies on clinical data from previous clearances of the predicate devices (e.g., K220127 for anxiety indication of NeuroStar Advanced Therapy System) and the subject device itself for the MDD indication (K211389, K183376, etc.). A retrospective open-label study is mentioned (Oliveira-Maia, Garcia-Guarniz, et al.) comparing Magstim and NeuroStar treated patients, but details on its sample size or provenance are not provided within this document.

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

This is not applicable for this type of 510(k) submission. Ground truth, in the direct sense of expert labels on clinical data, was not established for a new clinical test set. The submission relies on non-clinical comparative testing and the clinical validity established by the predicate device's existing clearances.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring expert adjudication was part of this 510(k) submission.

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 system, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable. This is a hardware/software medical device. While it contains software, its performance is evaluated as an integrated system for delivering TMS therapy, not as a standalone algorithm in the sense of AI for image analysis. The "standalone" performance here refers to the device's ability to generate the specified magnetic and electric fields, which was confirmed through non-clinical testing.

7. The type of ground truth used

For the non-clinical testing:

• The "ground truth" for the magnetic and electric field comparisons was established by direct physical measurements and finite element modeling (FEM) based on established scientific principles and FDA guidance.
• For the clinical indications, the "ground truth" (i.e., that the therapy is safe and effective for the stated indications) is based on the previously cleared clinical evidence for the predicate device (NeuroStar Advanced Therapy System K220127) and earlier clearances for the Magstim device for MDD. This is not "ground truth" generated by this submission directly, but rather relied upon from existing regulatory frameworks.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" in the context of machine learning or AI models within this 510(k) summary. The "training" for this device would refer to the engineering and design process, and the "data" would be the specifications and test results.

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

Not applicable. As per point 8, there's no mention of a training set in the context this question implies.

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visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:

• · Mag & More: PMD70-aCool Double coil Figure-8 (510575)
• MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
• MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
• · Neuronetics Inc .: NeuroStar coil
  The visor2 system must be operated by a trained physician and must not be used during surgical operations.

The visor2 system is a 3D navigation system, supporting external/surface positioning of labeling identified commercially available Transcranial Magnetic Stimulation (TMS) coils based on the anatomical and functional areas for which use of the coil has been FDA cleared and as identified in cleared labeling for the coil. The visor2 system optionally records and processes electrophysiological signals to guide the user in the TMS coil placement. The visor2 system is compatible with TMS stimulators identified in the labeling that meet IEC 60601-1 and IEC 60601-1-2 electrical safety and EMC standards, a compatible optical tracking system, and further compatible accessories. Optionally, a compatible amplifier identified in the labeling may be applied for measuring electrophysiological signals. The visor2 system must be operated by a trained physician, and must not be used during surgical operations.
The visor2 system consists of a cart, an All-in-One medical computer with touch interface, a mounting plate for an optional amplifier applied for EMG recording and a Tracking camera with mounting arm. There are two fundamental visor2 system variants: single or dual display. the second configuration is available with an additional touch display added next to the All-in-One computer. Both variants are identical with regard to hardware features.

The acceptance criteria for the visor2 system and the study results are detailed in the provided text. The device is a 3D navigation system that aids in the positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on MRI measurements or scalp landmarks, with optional EMG recording.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The provided text combines the acceptance criteria (defined as "Main PASS criteria:" or implicitly as "Pass" alongside the test method and results) and the reported device performance within the "Bench testing demonstrated that the performance parameters of the visor2 system meets pre-specified requirements and are substantially equivalent to those of the predicate device" section.

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