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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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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 and outpatient settings, including physicians' offices, clinics, and hospitals.

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

This document describes the Magstim HORIZON® TMS Therapy System, specifically focusing on K182853, which adds a new treatment protocol (iTBS) to a previously cleared device (K180907). The document demonstrates substantial equivalence to predicate devices, rather than presenting a de novo study with acceptance criteria and performance data for a novel device. Therefore, many of the requested sections (sample size, expert ground truth, adjudication, MRMC) are not applicable as they relate to clinical studies proving efficacy or diagnostic performance, which were not performed for this submission.

However, I can extract information related to the device's technical specifications and the basis for its safety and effectiveness claims.

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission for adding a treatment protocol, there aren't traditional "acceptance criteria" for performance that a new device would need to meet in a clinical trial. Instead, the acceptance criteria here are demonstrating that the addition of the iTBS protocol poses no new issues of safety or effectiveness, and that the device remains substantially equivalent to already cleared devices.

Table of "Acceptance Criteria" (demonstrated equivalency) and Reported Device "Performance" (characteristics for comparison):

Study Details (Not Applicable for this Submission Type):

As this is a 510(k) submission based on substantial equivalence for a minor modification (adding a treatment protocol) to an already cleared device, detailed clinical studies with the specific elements requested (sample sizes, expert ground truth, adjudication methods, MRMC studies) were not performed or required for this particular submission. The "study" here is primarily a comparative analysis to existing cleared devices and verification of the technical aspects of the new protocol addition.

1. Sample size used for the test set and the data provenance: Not applicable. No new clinical test set was used for this 510(k) submission. The data provenance is implied by the predicate devices being legally marketed in the US.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical efficacy was established by the predicate devices' historical data or studies, not new data for this submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 is not an AI/diagnostic imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the original clearance of the predicate devices, clinical efficacy would have been established through clinical trials and outcomes data. For this specific submission, the ground truth for safety and effectiveness of the iTBS protocol is implicitly based on its successful clearance and clinical use in the primary predicate device (Mag Vita TMS Therapy System w/Theta Burst Stimulation, K173620) and the physical and electrical equivalence of the HORIZON system to its prior clearance (K180907).
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense.
8. How the ground truth for the training set was established: Not applicable.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method for the test set:

   Not applicable. See point 3.

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. 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.

6. 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.

7. 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).

8. The sample size for the training set:

   Not applicable. No machine learning training set is mentioned or relevant for this type of device submission.

9. How the ground truth for the training set was established:

   Not applicable. No machine learning training set is mentioned.

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