(119 days)
The HORIZON™ 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.
The HORIZON® 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. The HORIZON® 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 antidepressant medication in the current episode. The HORIZON® 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.
This document is a 510(k) premarket notification from the FDA, approving the Magstim HORIZON™ TMS Therapy System. It states that the device is substantially equivalent to a predicate device and therefore does not contain all the detailed information typically found in a full clinical study report. Specifically, it focuses on non-clinical testing for substantial equivalence rather than a comparative clinical effectiveness study (MRMC) or standalone algorithm performance.
However, based on the provided text, we can extract details about the acceptance criteria (implicitly defined by the substantial equivalence argument), the study proving it meets these, and some related information:
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Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present explicit quantitative acceptance criteria as one might find for a novel device, but rather frames "acceptance" as demonstration of substantial equivalence to a previously cleared predicate device. The performance is assessed by comparing technical characteristics.
Criteria HORIZON® TMS Therapy System (Subject Device) HORIZON® Therapy System (K171051) (Primary Predicate) NeuroStar TMS Therapy System (K160703) (Secondary Predicate) Neurosoft TMS (K173441) (Secondary Predicate) Intended Use/Indications for Use Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Identical Identical Identical Sessions/week 5 5 5 5 Treatment Schedule 5 daily sessions for 6 weeks 5 daily sessions for 6 weeks 5 daily sessions for 6 weeks 5 daily sessions for 6 weeks Area of brain to be stimulated Left Dorsolateral Prefrontal Cortex Left Dorsolateral Prefrontal Cortex Left Dorsolateral Prefrontal Cortex Left Dorsolateral Prefrontal Cortex Waveform Biphasic Biphasic Biphasic Biphasic Core Material Air Air Ferromagnetic core Air Pulse Width 330μs (range given as 0.28-1.9) 340μs (range given as 0.28-1.9) 300μs 185μs Magnetic Field Intensity 120% of the MT 120% of the MT 120% of the MT 120% of the MT Stimulus Frequency 10 Hz 10 Hz 10 Hz 10 Hz Stimulus Train duration 4 sec 4 sec 4 sec 4 sec Inter-train interval 11-26 sec 26 sec 11-26 sec 11-26 sec Number of trains 75 75 75 75 Magnetic Pulses per Session 3000 3000 3000 3000 Treatment Session Duration 18.8 min-37.5 min 37.5 min 18.8 min – 37.5 min 18.8 min-37.5 min Maximum # of pulses per session (cumulative exposure) 60,000 6,000 5,000 72,000 (stand-alone), 240,000 (with PC) Maximum output amplitude (V/m) at 2cm 150 V/m 150 V/m 135V/m nominal Not disclosed by Manufacturer Electrical Safety Standards IEC 60601-1 (Ed. 3.1.) IEC 60601-1 Not explicitly stated for predicate in table, but general statement of meeting standards applies. Not explicitly stated for predicate in table, but general statement of meeting standards applies. EMC Standards EN 60601-1-2 (2007) EN 60601-1-2 Not explicitly stated for predicate in table. Not explicitly stated for predicate in table. Note: Bolded values highlight the parameters where the subject device differs from its primary predicate but aligns with secondary predicates, demonstrating substantial equivalence through a combination of existing cleared devices.
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Sample size used for the test set and the data provenance:
The document does not describe a test set in the context of a clinical trial with human subjects for performance evaluation like an AI/algorithm-based diagnostic device would. This is a premarket notification for a medical device (TMS system) based on substantial equivalence to predicates.
The "testing" mentioned is primarily non-clinical:
- Electrical safety and electromagnetic compatibility (EMC) testing: Done on the system itself to demonstrate compliance with standards (IEC 60601-1, EN 60601-1-2).
- Biocompatibility evaluation: Demonstrated adherence to ISO 10993-1.
- Acoustic output measurements: Conducted during IEC 60601-1 testing.
- Software verification and validation testing: To ensure software performs as intended.
- Magnetic field characteristics testing: To show substantial equivalence to the primary predicate.
There's no mention of a "test set" of patient data or clinical retrospective/prospective studies demonstrating diagnostic or treatment efficacy in the context of an algorithm's performance on patient data. This is a physical therapy device, not a diagnostic AI.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical "test set" with ground truth established by experts is described in this 510(k) summary for a TMS therapy system.
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Adjudication method for the test set:
Not applicable. See point 3.
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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. The device is a Transcranial Magnetic Stimulation (TMS) system for treating Major Depressive Disorder. It is not an AI diagnostic tool designed to assist human readers (e.g., radiologists) in interpreting data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of diagnostic AI. This is a therapeutic device. The "standalone" mention in the table under Neurosoft TMS refers to its ability to deliver pulses independent of a PC connection, not an algorithm's diagnostic performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for a clinical test set. The "ground truth" for the non-clinical testing relates to engineering and safety standards (e.g., whether the device output is within specified ranges, whether it meets electrical safety requirements).
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The sample size for the training set:
Not applicable. No machine learning training set is mentioned or relevant for this type of device submission.
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How the ground truth for the training set was established:
Not applicable. No machine learning training set is mentioned.
§ 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.