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The TMS Navigator TS helps users to plan, implement treatment involving TMS of the brain.

The system provides planning and navigation functions using anatomical MR data.

Regions of the brain to be stimulated can be determined on the basis of anatomy, functional areas or by entering previously calculated coordinates from brain atlases.

The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R20 and R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: C-100, C-B60, Cool-B70, Cool D-B80, MC-125, MC-B70, MCF-75, MCF-125, MCF-B65 and MMC-140-II.

The TMS Navigator TS is a navigation system specifically designed to support transcranial magnetic stimulation (TMS).

It uses position data of the patient's head and the TMS coil acquired by an optical tracking system for display and navigation. The realtime display of the position of the TMS coil in the displayed MR data set provides visual support for navigation. With the help of the software, one or more locations for the TMS treatment can be planned as well as stimulated locations can be recorded in the used data set and thus documented.

These functionalities support the following use case:

Planning, execution and documentation of a TMS stimulation in the human brain.

Transcranial magnetic stimulation (TMS) uses so-called TMS coils to generate alternating electromagnetic fields to target brain areas. The depth of penetration, extent and nature of this effect (inhibitory or exhibitory) is influenced by the strength and shape of the magnetic field and the repetition frequency used.

The provided text describes the Localite TMS Navigator TS device and its 510(k) submission for FDA clearance. The information focuses on non-clinical bench performance testing rather than human-in-the-loop or multi-reader multi-case studies using AI.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text.

The device in question, the Localite TMS Navigator TS, is a navigation system designed to support transcranial magnetic stimulation (TMS). Its primary function is to provide planning and navigation using anatomical MR data to determine and locate target areas in the brain for TMS treatment.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be related to its system accuracy in navigating to target locations. The study assessed this accuracy using a measurement phantom in a simulated use environment.

2. Sample Size and Data Provenance

• Sample Size Used for Test Set: "In total, 288 coordinate comparisons were deduced from eight test locations across 36 navigated TMS sessions."
• Data Provenance: The study was a "bench performance test" using a "measurement phantom and a TMS coil test probe in a simulated use environment." This indicates the data is retrospective and synthetic (from a phantom), not from human subjects. The location of the test environment is not explicitly stated, but the applicant's address is listed as Bonn, Germany.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth was established by the physical coordinates of the measurement phantom and the known positioning of the test probe, not by human expert consensus or clinical assessment.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was the objective, precisely defined physical locations on the measurement phantom. There was no need for human adjudication of image interpretations or clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The study described is a bench performance test assessing the device's accuracy in a simulated environment, not a multi-reader, multi-case clinical study involving human readers and AI assistance.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, in essence. The described study evaluates the "system accuracy" of the TMS Navigator TS in performing its navigation function. While it's a device that guides human users, the performance metrics (mm accuracy) are for the system's ability to locate and track precisely, independent of a specific human operator's skill in interpreting the display. It's a measure of the device's inherent precision.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was physical measurement or phantom-derived coordinates. The study states "based on eight test locations on the phantom, to which the test probe was navigated." This implies the physical, known coordinates of these test locations on the phantom served as the ground truth against which the device's navigated positions were compared.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated. The provided text describes the non-clinical bench performance testing for the test set. Information about the training set size for any underlying algorithms used in the device (if applicable, though the device description focuses on optical tracking and real-time display rather than a self-learning AI algorithm) is not included in this document.

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

• How Ground Truth for Training Set Was Established: Not explicitly stated. As with the training set size, this information is not provided in the document, likely because the performance study described is the validation of the final device, not a description of its development process or training data. Given the device's description, which emphasizes navigation and tracking rather than an AI model learning from medical images, it's possible that a "training set" in the AI sense isn't a primary component of its development, or at least not relevant to the described premarket bench testing.

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HORIZON® 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 HORIZON® TMS Therapy System with Navigation (HORIZON®) 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.

HORIZON® is an integrated system consisting of a combination of hardware, software, and accessories.

The provided document focuses on the 510(k) summary for the Magstim HORIZON® TMS Therapy System with Navigation (K183376). This submission is for a medical device (Transcranial Magnetic Stimulation System) for the treatment of Major Depressive Disorder. The document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm's performance, as the device is not described as an AI/ML product.

The document details the device's substantial equivalence to predicate devices based on technological characteristics, intended use, and non-clinical testing (electrical safety, EMC, biocompatibility, and software verification/validation). It does not describe performance metrics related to diagnostic accuracy, sensitivity, specificity, or other typical AI/ML acceptance criteria.

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and performance study details for an AI/ML device from the provided text. The device described is a hardware-based system with associated software, not an AI/ML algorithm.

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