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510(k) Data Aggregation
(294 days)
The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.
The MagVenture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.
The provided text describes the acceptance criteria and supporting studies for the MagVenture TMS Atlas Neuro Navigation System.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Tracking System Accuracy | Static accuracy better than or equal to 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool) | 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool) | Tracking System Accuracy Test (from NDI reports) |
| System Accuracy (Navigation) | Navigation accuracy < 5 mm (using TMS coil) | Monte Carlo Simulations: 4.55 mm mean (with 4 markers), 3.5 mm (with 6 markers) | Monte Carlo Simulations |
| Navigation accuracy < 5 mm (when navigating with hand-held probe) | 3 mm +/- 2.1 mm (when navigating with hand-held probe) | (Derived from comparison table, not directly from study results in the text) | |
| Navigation algorithm can navigate accurately with an accuracy of < 5mm in a real-world setting | Phantom Testing: Target A (left temporal) mean 3.5 mm; Target B (vertex) mean 2.0 mm (Anatomical marker set), 4.6 mm, 2.6 mm (Carved "X" marker set) | Phantom Study | |
| Complete system achieves navigation accuracy for TMS coil placement within 5mm | User is able to navigate the TMS coil to a defined brain target within 5mm | Human Volunteer Study (complete navigation session) | |
| Coil Compatibility | Absence of significant spatial distortion in position measurements. Successful coil calibration. Effective temporal filtering during TMS discharge. Achieve positioning accuracy necessary for each TMS coil to function as per their cleared Indications and Intended Use. | All tested TMS coil and stimulator combinations do not distort the magnetic field. Coil calibration performed successfully for all. Compatible with tested TMS discharge protocols. Achieved navigation accuracy of the system is < 4mm for compatible coils. Specific coil accuracy: CB60 (<3mm), CB70 (2mm), CoolB65 (2mm), CoolB70 (3mm), CoolDB80 (2mm), MCFB65 (4mm), MCFB70 (2mm). | Compatibility Testing |
| Product Safety Standards | Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 80002-1, IEC 62366, IEC 62304, ISO 14971 | Compliant Test Reports | Product Safety Standards Testing |
| Software Verification & Validation | Software complies with predetermined specifications and relevant standards/guidance documents. | Test results indicate compliance. | Software V&V reports |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several tests:
- Monte Carlo Simulations:
- Sample Size: 10,000 runs using realistic position measurement noise conditions.
- Data Provenance: Simulated data based on literature for realistic noise conditions. This is a computational study, not directly using patient data.
- Tracking System Accuracy:
- Sample Size: Not explicitly stated, but mentioned as "for every shipment (100% incoming inspection)." This suggests continuous testing of components.
- Data Provenance: Test report provided by NDI (tracking system manufacturer).
- Coil Compatibility:
- Sample Size: All claimed MagVenture TMS coils (C-B60, Cool-B65, Cool-B70, Cool D-B80, MCF-B65, MCF-B70, and C-B70) were tested.
- Data Provenance: Bench testing performed on physical coils and stimulators.
- Phantom Navigation Testing:
- Sample Size: 30 iterations for each of the four tests (Target A with anatomical markers, Target A with carved "X" markers, Target B with anatomical markers, Target B with carved "X" markers).
- Data Provenance: Phantom head (real-world setting simulation).
- Human Volunteer Navigation Session:
- Sample Size: "a human volunteer" (singular).
- Data Provenance: Prospective data from a human volunteer. The volunteer had a pre-existing anatomical (T1 weighted) MRI scan and a segmented gray matter map.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for any of the described test sets.
- For Monte Carlo simulations, the "ground-truth" was likely defined computationally within the simulation model.
- For the phantom study, the "ground truth" measurement was obtained independently on the phantom head, but the method for establishing this ground truth and whether it involved experts is not detailed.
- For the human volunteer study, predefined brain targets were used, but the method for defining these targets (e.g., if experts identified them) is not specified.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test sets. The results appear to be based on direct measurements or computational outputs rather than expert agreement on ambiguous cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies focus on the standalone performance of the device and its components, or its accuracy in comparison to a ground truth, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance was assessed:
- Monte Carlo simulations assessed the mapping algorithm and navigation accuracy computationally without human interaction beyond setting up the simulation parameters.
- Coil compatibility testing evaluated the physical and electromagnetic properties related to the navigation system's function for various coils.
- The reported "Tracking system accuracy" (1.4 mm RMS, 0.5 degrees RMS) refers to the accuracy of the BrainTRAK position tracker itself, a component of the system.
While the "System Accuracy" involves a complete system which implies integration, the foundational "Navigation Principle" itself is also verified algorithmically.
7. The Type of Ground Truth Used
- Monte Carlo Simulations: Computational "ground-truth" defined within the simulation model for comparison with the targeted site.
- Tracking System Accuracy: Intrinsic accuracy of the NDI tracking system, likely measured against known physical standards.
- Coil Compatibility: Intrinsic physical properties and measurements related to magnetic field distortion and successful calibration.
- Phantom Navigation Testing: "ground-truth' measurement on a phantom head obtained independently of the complete TMS Atlas system. The nature of this ground truth (e.g., precise physical markings, pre-defined coordinates) is not further elaborated.
- Human Volunteer Navigation Session: "defined brain target" based on the volunteer's anatomical (T1 weighted) MRI scan and a segmented gray matter map.
8. The Sample Size for the Training Set
The document describes the MagVenture TMS Atlas Neuro Navigation System as a neuronavigation system that performs automatic tissue segmentation from MRI data. However, it does not explicitly mention a training set sample size for any machine learning models that might be used within this automatic segmentation routine or any other part of the system. The focus is on verification and validation of the integrated system and its components.
9. How the Ground Truth for the Training Set was Established
Given that a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. The focus of the provided text is on demonstrating the performance and safety of the final device, rather than detailing the development process of its internal algorithms.
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