(176 days)
The Horizon® 3.0 TMS Therapy System is intended to produce and deliver 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.
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 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 Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from 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 and outpatient 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 text describes a 510(k) premarket notification for the Magstim Horizon 3.0 TMS Therapy System, seeking substantial equivalence to existing devices for the treatment of Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD).
However, the document does not contain the results of a study designed to directly prove the device meets specific acceptance criteria based on clinical performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and limited non-clinical testing.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available from the provided text in the way they would be for an AI/ML diagnostic or prognostic device.
Here's an analysis based on the available information:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The device, Magstim Horizon 3.0 TMS Therapy System, is a medical device for therapeutic intervention (Transcranial Magnetic Stimulation), not a diagnostic or prognostic device that typically has performance metrics like sensitivity or specificity. The "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices, focusing on safety and effectiveness.
The "study" referenced for performance is primarily non-clinical testing and reliance on prior FDA clearances and published literature for predicate devices to support the extension of indications for use.
1. A table of acceptance criteria and the reported device performance:
Since the device is a therapeutic system and not a diagnostic one, the acceptance criteria are not in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are centered on demonstrating that the proposed changes (primarily for OCD treatment indication) do not raise new questions of safety or effectiveness compared to predicate devices, and that the device can reliably deliver the therapy.
| Acceptance Criteria (Demonstrated Equivalence Aspects) | Reported Device Performance (Summary from Submission) |
|---|---|
| Software Functionality & Safety (OCD Protocol) | Software verification & validation according to IEC 62304 and company quality procedures, considered a well-established method. |
| System Therapeutic Delivery (OCD Protocol) | Performance verification confirmed reliable and safe delivery of the OCD protocol at maximum output within recognized safety temperature limits, referencing recognized standards and prior protocols (FR Recognition Number 19-46, K182853). |
| Equivalence of Magnetic Field Profiles (OCD Protocol) | Finite Element Method (FEM) and statistical analysis modeling in COMSOL showed induced E-field profiles of Horizon 3.0 Ez Cool Coil and NeuroStar Advanced Therapy coil are equivalent, with an average difference of ±5% at distances of 1 to 4 cm from the coil surface. This aligns with FDA guidance for rTMS systems. |
| Human Factors Testing (User Interface & Coil Positioning) | Human Factors testing performed according to HE 75 and IEC 62366, demonstrating that representative TMS users could appropriately position the coil and follow the treatment definition protocol with low variability after brief training. |
| Electrical, Mechanical Safety, EMC, Alarm Systems, Biocompatibility | Previous data from K211389 submission remains valid; no new testing was deemed necessary. |
| Clinical Efficacy (Indirect through Predicate Equivalence) | Magstim figure-of-eight stimulating coils were previously determined substantially equivalent to NeuroStar coils for MDD (K143531). A retrospective open-label study (Oliveira-Maia, Garcia-Guarniz, et al.) concluded no statistically significant differences in outcomes between Magstim and NeuroStar treated patients for depression, suggesting equivalent antidepressant efficacy. This supports the extension of indications to OCD based on coil equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Software Verification & Validation: The sample size for testing specific software functions or modules is not explicitly stated, but it would involve testing different use cases and parameter configurations. The data provenance is internal to the manufacturer's testing processes.
- Performance Verification of Therapeutic Delivery: Not specified as a typical patient "test set." Verification involves testing the device under various operational conditions.
- FEM Modeling: This is a computational simulation, not a physical test set with human subjects.
- Human Factors Testing: The sample size of "representative TMS users" is not explicitly stated. The provenance is likely internal testing data.
- Clinical Efficacy (Retrospective Study): The retrospective open-label study referenced (Oliveira-Maia, Garcia-Guarniz, et al.) is external scientific literature, not a study specifically conducted for this 510(k). The sample size for this study is not provided in the snippet, nor is the country of origin. It is a retrospective study.
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)
This is not applicable in the context of this 510(k) submission, as it focuses on device safety and functional equivalence for a therapeutic system, not on establishing ground truth for diagnostic classifications by expert consensus. The "ground truth" for the device's function is its ability to reliably and safely deliver magnetic stimulation as intended, which is verified through engineering tests and adherence to standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is typically used in studies where human readers independently evaluate data and their findings require reconciliation to establish a ground truth. The non-clinical tests and simulations for the TMS system don't involve this type of 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
Not applicable. This device is a therapeutic system, not a diagnostic or AI-assisted interpretation tool where "human readers" would be involved in interpreting cases with or without AI assistance. The retrospective clinical study referenced in the submission is a comparative efficacy study of two different TMS devices, not an MRMC study involving AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device itself is a clinical tool used by a human operator (licensed physician). There is no "algorithm only" performance for a therapeutic TMS system. The software and hardware perform specific functions, but the overall therapy involves human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Software V&V: Ground truth is defined by specified software requirements and expected outputs.
- Performance Verification: Ground truth is defined by recognized safety limits and therapeutic delivery specifications (e.g., maximum output, temperature limits) as per international standards.
- FEM Modeling: Ground truth is derived from the physics principles governing electromagnetic fields and computational models, validated against known physical laws and prior successful device models.
- Human Factors: Ground truth relates to user comprehension, ability to perform tasks, and low variability in coil positioning, assessed against defined human factors engineering principles and successful task completion.
For the claim of substantial equivalence for clinical efficacy:
- Prior Equivalency Determination (K143531): FDA's prior determination of substantial equivalence for MDD treatment implies an acceptance of equivalent clinical outcomes based on comparative data.
- Retrospective Open-Label Study: The ground truth for this study would be patient outcomes (e.g., reduction in depression symptoms) as measured by clinical scales, which is a form of outcomes data.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that undergoes a "training phase" on a dataset in the conventional sense. The development of the device follows engineering design, verification, and validation principles.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this medical device's development or regulatory submission.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.