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510(k) Data Aggregation
(90 days)
Horizon 3.0 TMS Therapy System 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation 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 Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals.
Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
The provided document is a 510(k) Premarket Notification from the FDA for the Magstim®Horizon® 3.0 TMS Therapy System. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The device discussed is the Magstim®Horizon® 3.0 TMS Therapy System, and the submission is a 510(k) to demonstrate substantial equivalence to a previously cleared version (K222171). The testing described is primarily non-clinical bench testing focused on changes made to the device's camera tracking system and EMG amplifier, ensuring these changes do not raise new questions of safety or effectiveness and that the performance is equivalent or better than the predicate device. No clinical studies or human reader studies (MRMC) were conducted or mentioned as a requirement for this particular submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on demonstrating performance equivalent to or better than the predicate device, especially for the modified components (camera tracking and EMG). The performance metrics are largely quantitative measurements from bench testing.
| Acceptance Criteria (Expected Result) | Reported Device Performance (Actual Results) |
|---|---|
| Stress Testing - Sample Rate: Tracking remains stable under load to support sampling rates of 20Hz and 50Hz. (These rates are the highest for FDA cleared protocols - OCD Protocol and iTBS Protocol). | Actual Results: Maintains a constant sample rate above 50Hz. 50Hz chosen as that is the fastest rate of delivery out of cleared protocols. Under Abnormal PC Load: 52Hz min recorded. Average Capture Rate in Normal Conditions: 120Hz. Equivalent to Predicate Device. |
| Stress Testing - Data Storage: 1000 rMT positions can be stored and 10,000 stimuli positions can be stored. | Actual Results: Supports recording of 1000 Simultaneous MT Locations for Motor Hotspot procedures and recording of up to 12,000 Stimuli which is sufficient for treatment (Maximum stimuli from FDA protocol is 3000) – Equivalent to Predicate Device. |
| Positional and Volumetric Accuracy - Camera Accuracy: <= 0.25mm Root Mean Squared (RMS) Positional Accuracy. | Actual Results: 0.16mm RMS Positional Accuracy – Equivalent to Predicate Device. |
| Landmark Registration Accuracy (Rigid Body Testing): <= 1mm RMS Rigid-body Positional Accuracy. | Actual Results: 0.45mm RMS Rigid-body Positional Accuracy - Equivalent to Predicate Device. |
| Orientational Accuracy: <= 5.5 degrees RMS Orientational Accuracy. | Actual Results: 1.8 degrees RMS Orientational Accuracy. Equivalent to Predicate Device, provides an equivalent level of rotational accuracy. |
| Treatment Delivery Performance on Phantom Head: Pickup coil should detect a reading of the same voltage induced at the MT hotspot and Treatment Target (+/- 5%). | Actual Results: Over 20 samples (repeat of 10 tests for MDD and 10 tests for OCD) there was an average difference of 1.02% for MDD and 1.92% for OCD of the induced voltage when measured at the expected treatment target following the principles of operation. Resulting in a combined average difference of 1.47% from the voltage induced in a search coil at the MT location compared to when it is placed at the treatment location following the Navigation software. The treatment location was determined to be the location presented by Navigation software and when the software indicated it was in the position (green). Equivalent to Predicate Device. When following the same principles of operation as the predicate device – the new tracking system results in equivalent output. |
| Direct Accuracy Comparison to Manual Method and Predicate Device - Overall System Accuracy: The mean difference between the manual method and the subject device navigation method is equivalent or better than the predicate device navigation method compared to the same manual method (< 4.0mm). | Actual Results: MDD Mean Difference to Manual Method (5.5cm forward from MT Hotspot): 1.51mm (Std. Dev 1.14mm)OCD Mean Difference to Manual Method (4cm forward from MT Hotspot): 1.66mm (Std. Dev 0.76mm)Compared to the results of the predicate device:Predicate – 3.0mm Mean Delta (Std. Dev 1.8mm)Subject – 1.5mm (Std. Dev 1.1mm)Equivalent to Predicate Device – subject device offers better approximation/guidance to the treatment target in accordance with the principles of operation. |
| EMG Performance - Timing Jitter: < 5ms Jitter (TMS Pulse to EMG Capture). | Actual Results: Timing Jitter Measured: Maximum of 3.25ms and mean of 1.68ms over samples. Equivalent to Predicate Device. All measured values of the system are within tolerance. |
| EMG Performance - Noise Level: < 5uV RMS. | Actual Results: Noise Level Measured: 3.03uV RMS. Equivalent to Predicate Device. All measured values of the system are within tolerance. |
| EMG Performance - Waveform Accuracy: error of < 10% in Amplitude and Time. | Actual Results: Waveform Accuracy Measured: Maximum Amplitude Error - 6.5%, Maximum Pulse Width Error - 3%, Maximum Frequency Error - 3.16%. Equivalent to Predicate Device. All measured values of the system are within tolerance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Positional and Volumetric Accuracy - Camera Accuracy: "A reflective marker is stepped through 1000 different positions (ground truths) with 30 samples taken at each position."
- Treatment Delivery Performance on Phantom Head: "Over 20 samples (repeat of 10 tests for MDD and 10 tests for OCD)."
- Other tests like "Stress Testing," "Landmark Registration Accuracy," "Orientational Accuracy," "Direct Accuracy Comparison," and "EMG Performance" indicate "samples" but do not specify a precise number for each measurement run, though the methods imply multiple measurements were taken (e.g., "moved along rotational axes by known amounts," "known waveforms are input," which suggests a range of conditions).
- Data Provenance: The tests are described as non-clinical testing using simulated settings and phantom heads. The data is thus synthetic/experimental, not from human patients. The company is based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the non-clinical bench tests appears to be established by the physical and measurable setup of the experiments themselves (e.g., "known positions," "known waveforms," "precisely positioned and secured pickup coil"). Expert consensus is not relevant for this type of engineering performance testing.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical, quantitative bench tests with direct measurements against pre-defined engineering specifications. There is no human interpretative element requiring adjudication.
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 MRMC comparative effectiveness study was done or required. The submission explicitly states: "There is no clinical testing required to support this submission." The device modifications are to the tracking camera, EMG, and associated software, and the testing focuses on ensuring their fundamental performance characteristics are equivalent or better than the predicate. This is not an AI diagnostic algorithm that assists human readers in interpreting medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "standalone" performance closest to what might be inferred is the performance of the camera tracking system and EMG amplifier in isolation, as tested in the bench assessments. The results detailed in the table (e.g., positional accuracy, orientational accuracy, EMG jitter, noise, waveform accuracy) are essentially "algorithm only" or component-level performance metrics, demonstrating the technical capabilities of the new components. However, this is not a diagnostic AI algorithm in the traditional sense that "stands alone" to provide a clinical output.
7. The type of Ground Truth Used
The ground truth used for these non-clinical tests is based on engineering measurements and pre-defined physical parameters.
- For positional accuracy tests: reflective markers are stepped through "1000 different positions (ground truths)".
- For treatment delivery performance: "known position on the phantom head" and "precisely positioned and secured pickup coil at the ideal location."
- For EMG performance: "known waveforms are input into the EMG interface using a function generator."
8. The Sample Size for the Training Set
This information is not applicable / not provided. This submission is for a medical device (TMS system) with updated hardware and software components, not for a deep learning or AI model trained on a large dataset of patient data. The "software" updates mentioned are related to integrating the new hardware and improving user interaction, not for training a predictive model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided for the same reasons as #8. No "training set" in the context of an AI/ML model for clinical tasks is mentioned or implied.
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