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Horizon 3.0 TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

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 depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Horizon® 3.0 TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.

The provided text is a 510(k) summary for the Magstim Horizon 3.0 TMS Therapy System. It states that the device is substantially equivalent to a predicate device and does not involve clinical data from a new study. Therefore, the information typically requested regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance for a new study validating the device's performance against acceptance criteria is not present. Instead, the submission relies on demonstrating equivalence to previously cleared devices based on technological characteristics and existing clinical evidence for those predicates.

However, I can extract and format information regarding the basis for this substantial equivalence claim, particularly focusing on the non-clinical testing performed to show equivalence of the magnetic and electric fields, which serves as a proxy for meeting performance criteria for the extended indication.

Here's a breakdown of the information that can be extracted, and where the requested details are not applicable or provided:

1. A table of acceptance criteria and the reported device performance

The submission does not present a formal "acceptance criteria table" with numerical thresholds directly met by the subject device's performance. Instead, the performance is demonstrated by showing "equivalence" to a predicate device. The key performance metrics discussed are related to magnetic and electrical field characteristics.

Table: Comparative Performance Criteria (demonstrated by equivalence to predicate)

2. Sample size used for the test set and the data provenance

• Non-clinical Testing:
  • Sample Size for Magnetic/Electric Field Comparative Testing: Not specified in terms of "samples." This involves physical measurements and computational modeling of the devices themselves rather than a dataset of patient outcomes.
  • Data Provenance: The testing was conducted by Magstim and involved direct comparison of their device (Horizon 3.0) with the predicate (NeuroStar Advanced Therapy System). No country of origin for a data set is specified as it's not a patient-based study. This was primary testing to support the submission (prospective, in a sense, as it was done for the 510(k)).
• Clinical Data (referenced for equivalence, not a new study): The submission explicitly states, "No new clinical data is being leveraged for this 510(k) submission." Instead, it relies on clinical data from previous clearances of the predicate devices (e.g., K220127 for anxiety indication of NeuroStar Advanced Therapy System) and the subject device itself for the MDD indication (K211389, K183376, etc.). A retrospective open-label study is mentioned (Oliveira-Maia, Garcia-Guarniz, et al.) comparing Magstim and NeuroStar treated patients, but details on its sample size or provenance are not provided within this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable for this type of 510(k) submission. Ground truth, in the direct sense of expert labels on clinical data, was not established for a new clinical test set. The submission relies on non-clinical comparative testing and the clinical validity established by the predicate device's existing clearances.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring expert adjudication was part of this 510(k) submission.

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 Transcranial Magnetic Stimulation system, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware/software medical device. While it contains software, its performance is evaluated as an integrated system for delivering TMS therapy, not as a standalone algorithm in the sense of AI for image analysis. The "standalone" performance here refers to the device's ability to generate the specified magnetic and electric fields, which was confirmed through non-clinical testing.

7. The type of ground truth used

For the non-clinical testing:

• The "ground truth" for the magnetic and electric field comparisons was established by direct physical measurements and finite element modeling (FEM) based on established scientific principles and FDA guidance.
• For the clinical indications, the "ground truth" (i.e., that the therapy is safe and effective for the stated indications) is based on the previously cleared clinical evidence for the predicate device (NeuroStar Advanced Therapy System K220127) and earlier clearances for the Magstim device for MDD. This is not "ground truth" generated by this submission directly, but rather relied upon from existing regulatory frameworks.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" in the context of machine learning or AI models within this 510(k) summary. The "training" for this device would refer to the engineering and design process, and the "data" would be the specifications and test results.

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

Not applicable. As per point 8, there's no mention of a training set in the context this question implies.

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The Brainsway Deep Transcranial Magnetic Stimulation System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.

The Brainsway DTMS System enables direct non-invasive activation of brain structures. TMS is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.

The Brainsway DTMS System is composed of the following five main components:

• Electromagnetic Coil (HAC-Coil)
• TMS Neurostimulator
• Cooling System
• Positioning Device
• Personal Head Cap

The provided text describes a clinical study to establish the safety and effectiveness of the Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System for the treatment of Obsessive-Compulsive Disorder (OCD).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for effectiveness appear to be based on the primary effectiveness endpoint: a statistically significant reduction in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores compared to sham treatment. Additionally, clinically meaningful reductions in OCD severity are highlighted.

The ITT analysis set (N=99) did not achieve statistical significance (p-value: 0.0988) due to a higher reduction in YBOCS in the Sham group (4.1 points) compared to the mITT Sham group (3.3 points), but a clinically meaningful reduction (6.0 points) was still observed in the DTMS group. |
| Secondary Endpoints:

• Response rate (≥30% YBOCS reduction from baseline) at 6 weeks.
• Partial Response rate (≥20% YBOCS reduction from baseline) at 6 weeks.
• Improvement in CGI-I ("Improved" category: moderately improved to very much improved) at 6 weeks.
• Improvement in CGI-S ("Improved" category) at 6 weeks.
• Sustained YBOCS reduction at 10 weeks. | Met (with qualifications):
• Response Rate: DTMS: 38.1% (16/42), Sham: 11.1% (5/45) in mITT.
• Partial Response Rate: DTMS: 54.8% (23/42), Sham: 26.7% (12/45) in mITT.
• CGI-I "Improved": DTMS: 49% (20/41), Sham: 21% (9/43) in mITT.
• CGI-S "Improved": DTMS: 61% (25/41), Sham: 33% (14/43) in mITT.
• YBOCS at 10 Weeks: Adjusted mean YBOCS reduction of 6.5 points (95% CI: [4.3;8.7]) in the DTMS group, indicating stability.

(Note: Formal statistical testing was stopped at the first secondary endpoint, so p-values for other secondary endpoints were unadjusted for multiplicity, but results show favorable trends for DTMS). |
| Safety: Device is safe and tolerable, with adverse events being minor, reversible, and typical for TMS devices, and no significant differences in vital signs, physical/neurological exams, or cognitive status between treatment groups. Absence of serious related adverse events. | Met:

• AEs reported by 73% (DTMS) vs. 69% (Sham).
• Most frequent AE was headache (37.5% DTMS, 35.3% Sham).
• Other pain/discomfort (administration site, jaw, facial, muscle, neck, dizziness) were mild/moderate and resolved.
• No reports of hypoacusis (hearing loss).
• No notable differences in vital signs, physical/neurological exams between groups.
• One SAE reported, assessed as not device-related (suicidal thoughts preceding study). |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Clinical Study Population):
  • Total enrolled: 100 subjects.
  • ITT Analysis Set (received at least one treatment): 99 subjects (48 DTMS, 51 Sham).
  • mITT Analysis Set (met eligibility criteria): 94 subjects (47 DTMS, 47 Sham). This was the principal data analysis set for efficacy.
  • Per-Protocol Analysis Set (without major protocol deviations): 93 subjects (46 DTMS, 47 Sham).
• Data Provenance: Prospective, randomized, double-blinded, multi-site, sham-controlled clinical trial. The study was conducted at 11 study sites in the United States (9 sites), Israel (1 site), and Canada (1 site).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The ground truth for the effectiveness of the treatment was established through clinical assessments using standardized scales like the YBOCS, Sheehan Disability Scale (SDS), and Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I).
• These assessments were performed by independent raters. While the exact number of independent raters or their specific qualifications (e.g., years of experience as psychiatrists or psychologists) is not explicitly stated, the study design mentions that "the independent rater" was blinded to the treatment administered. This implies that trained clinical professionals, likely psychiatrists or psychologists, administered these critical rating scales.

4. Adjudication Method for the Test Set

• The study design involved a double-blinded approach where both study personnel (including the operator and independent rater) and study subjects were blinded to whether active or sham treatment was administered.
• The primary and secondary outcome measures (YBOCS, SDS, CGI-S, CGI-I) are standardized clinical scales that are typically administered by trained personnel. There is no explicit mention of an "adjudication method" like 2+1 or 3+1 for discordance between multiple experts for individual case ground truth, as these scales are designed for direct clinical assessment. The "ground truth" here is the patient's symptom severity and improvement as measured by these scales.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study directly evaluated the effectiveness of a medical device (DTMS system) for treating OCD in patients, not an AI system assisting human readers. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable to this study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone (algorithm only) performance study was not done. The study evaluated a medical device that is administered to patients by trained operators, with outcomes assessed by independent clinical raters. This is a human-in-the-loop system in the context of patient treatment and assessment, not an AI algorithm acting autonomously.

7. The Type of Ground Truth Used

• The ground truth used for determining treatment effectiveness was based on expert clinical assessments and standardized patient-reported outcomes. Specifically:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS): A clinician-administered scale that measures the severity of OCD symptoms.
  • Sheehan Disability Scale (SDS): A patient-rated scale that assesses functional impairment.
  • Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I): Clinician-rated scales that measure global severity and improvement of illness.
  • Response/Remission Definitions: Pre-defined thresholds of YBOCS score reduction or absolute score for clinical response and remission.
• For safety, ground truth was assessed through adverse event reporting, vital signs, physical/neurological examinations, and cognitive tests.

8. The Sample Size for the Training Set

• This was a clinical trial evaluating a medical device, not a machine learning model. Therefore, there was no "training set" in the context of machine learning model development. The sample size used for the clinical study (94-99 subjects in the analysis sets) was for direct evaluation of the device's efficacy and safety.

9. How the Ground Truth for the Training Set Was Established

• As there was no machine learning "training set," this question is not applicable. The clinical trial directly provided the data (including outcome measures like YBOCS scores) used to assess the device's performance.

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Nexstim Navigated Brain Therapy (NBT®) System 2 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 Nexstim NBT® System 2 is a repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder (MDD) without inducing seizure in patients who have failed one antidepressant medication.

The Nexstim NBT System 2 is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.

The Nexstim NBT System 2 consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBT System 2 is provided by the software.

The Nexstim NBT System 2 combines magnetic resonance imaging-based (MRI-based), three-dimensional (3-D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy.

The Nexstim NBT System 2 software is used to import a patient's MR image slices through standard DICOM communication protocols, and generates an accurate 3-D model of the patient's head which can be "peeled back" to reveal the anatomical structures of the brain.

The provided text describes the Nexstim Navigated Brain Therapy (NBT) System 2, a repetitive transcranial magnetic stimulation (rTMS) system for treating Major Depressive Disorder. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or details of a study directly proving the device meets acceptance criteria in the format requested for AI/ML devices.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical trial results or performance metrics against pre-defined acceptance criteria typical for novel AI/ML device evaluations.

It primarily details:

• Device Description and Intended Use
• Technology Comparison with predicate devices (showing similar technical characteristics)
• Summary of Performance Testing related to general medical device standards (sterilization, biocompatibility, software verification, electrical safety, EMC, and usability).

There are two studies mentioned under "Performance Testing – Bench Verification," which relate to the device's methods for determining motor threshold (MT) and coil localization, comparing them to manually-determined methods. However, these are not presented as a "study that proves the device meets the acceptance criteria" in the context of clinical effectiveness or diagnostic accuracy, which is often what is implied by "acceptance criteria" and "reported device performance" for AI/ML enabled devices.

Given the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Study Details (Based on provided text)

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or device performance in the context of clinical efficacy or diagnostic accuracy in a table format. Instead, it refers to compliance with various medical device standards and internal specifications. The "Performance Testing - Bench Verification" section mentions two studies that compare specific aspects of the device's function (MT determination and coil localization) to other methods, suggesting "no significant statistical difference" or "substantially equivalent results" as outcomes for these functional aspects, which could be interpreted as meeting an implicit acceptance criterion of equivalence for these specific functions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "Study Comparing Nexstim's Electromyography-Determined Motor Threshold (MT) Method to the Manually-Determined MT Method (O'Reardon, 2007; Pridmore, 1998)" and "Study Comparing Nexstim's Navigated Coil Localization Method to Manually-Determined Method (Ahdab, 2010)".

• Sample Size: Not specified in the provided text for either study.
• Data Provenance: Not specified in the provided text for either study (e.g., country of origin, retrospective or prospective). The studies are referenced by author and year, suggesting they are published literature or internal studies referring to published methods.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the provided text. For the MT and coil localization comparison studies, "manually-determined methods" serve as a reference, implying human expertise, but details are not given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified in the provided text.

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 Nexstim NBT System 2 is not an AI-assisted diagnostic device where "human readers" would be involved in interpreting data with or without AI. It is a therapeutic device (rTMS system). The listed comparative studies focus on functional aspects of the device (MT determination and coil localization) rather than comparative effectiveness studies in the context of improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the typical sense of standalone AI performance. The device is a system operated by a trained medical professional. The functional comparisons (MT determination, coil localization) are aspects of the system's operation that are being compared to manual methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the Motor Threshold (MT) determination, the ground truth appears to be established by a "manually-determined MT method" (implied expert determination, likely involving visual and/or manual assessment of muscle twitch).
• For the Navigated Coil Localization, the ground truth is a "manually-determined method (moving the coil 5.5 cm anteriorly from the motor cortex)," which is a standard anatomical targeting approach.

8. The sample size for the training set

Not applicable/specified. The document does not describe the device as an AI/ML system that undergoes "training." The software development process is mentioned, but without details on a training set for model development.

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

Not applicable/specified, as there is no mention of an AI/ML "training set."

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