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visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:

• · Mag & More: PMD70-aCool Double coil Figure-8 (510575)
• MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
• MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
• · Neuronetics Inc .: NeuroStar coil
  The visor2 system must be operated by a trained physician and must not be used during surgical operations.

The visor2 system is a 3D navigation system, supporting external/surface positioning of labeling identified commercially available Transcranial Magnetic Stimulation (TMS) coils based on the anatomical and functional areas for which use of the coil has been FDA cleared and as identified in cleared labeling for the coil. The visor2 system optionally records and processes electrophysiological signals to guide the user in the TMS coil placement. The visor2 system is compatible with TMS stimulators identified in the labeling that meet IEC 60601-1 and IEC 60601-1-2 electrical safety and EMC standards, a compatible optical tracking system, and further compatible accessories. Optionally, a compatible amplifier identified in the labeling may be applied for measuring electrophysiological signals. The visor2 system must be operated by a trained physician, and must not be used during surgical operations.
The visor2 system consists of a cart, an All-in-One medical computer with touch interface, a mounting plate for an optional amplifier applied for EMG recording and a Tracking camera with mounting arm. There are two fundamental visor2 system variants: single or dual display. the second configuration is available with an additional touch display added next to the All-in-One computer. Both variants are identical with regard to hardware features.

The acceptance criteria for the visor2 system and the study results are detailed in the provided text. The device is a 3D navigation system that aids in the positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on MRI measurements or scalp landmarks, with optional EMG recording.

Here's a breakdown of the requested information:

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

The provided text combines the acceptance criteria (defined as "Main PASS criteria:" or implicitly as "Pass" alongside the test method and results) and the reported device performance within the "Bench testing demonstrated that the performance parameters of the visor2 system meets pre-specified requirements and are substantially equivalent to those of the predicate device" section.

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The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.

The Neural Navigator combines MRI-based, 3-D localization of cortical motor areas of the brain with non-invasive TMS and simultaneous 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 Neural Navigator software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.

The provided text describes the 510(k) premarket notification for the Neural Navigator device. While it asserts substantial equivalence based on performance testing, it does not explicitly define "acceptance criteria" in a quantitative table with specific thresholds as would be typical for a detailed study report. However, it implicitly presents performance metrics and their comparison to predicate devices, which serve as the basis for acceptance.

Here's an attempt to extract and rephrase the information to fit the requested format, acknowledging the limitations of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria with defined pass/fail thresholds. Instead, it compares the Neural Navigator's performance to its predicate devices, implying that performance comparable to or better than the predicate is considered acceptable.

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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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