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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 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 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 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.

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

The provided document is a 510(k) Premarket Notification from the FDA for the Magstim®Horizon® 3.0 TMS Therapy System. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The device discussed is the Magstim®Horizon® 3.0 TMS Therapy System, and the submission is a 510(k) to demonstrate substantial equivalence to a previously cleared version (K222171). The testing described is primarily non-clinical bench testing focused on changes made to the device's camera tracking system and EMG amplifier, ensuring these changes do not raise new questions of safety or effectiveness and that the performance is equivalent or better than the predicate device. No clinical studies or human reader studies (MRMC) were conducted or mentioned as a requirement for this particular submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on demonstrating performance equivalent to or better than the predicate device, especially for the modified components (camera tracking and EMG). The performance metrics are largely quantitative measurements from bench testing.

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The Magstim D702 coil is a stimulating coil intended for use with the Magstim® 2002 Stimulating Unit or the Magstim® Rapid2 Stimulating Unit for the purpose of peripheral nerve stimulation for diagnostic purposes. The coil is an accessory to the Magstim ® 2002 Stimulating Unit, and the coil is an accessory to the Magstim® Rapid2 Stimulating Unit.

The Magstim D702 coil is designed for use with the Magstim 2002 stimulator or the Magstim Rapid2 stimulator. The Magstim D70 coil provides a method of non-invasively delivering its output to a target such as the peripheral nerves. Discharge current through the coil generates a brief, high intensity magnetic pulse. When the coil is applied to a conductive medium such as the human body, eddy currents are produced in the medium by electromagnetic induction. This stimulation method enables deep and otherwise inaccessible nerves to be stimulated easily and relatively painlessly. In addition, no skin preparation is required and stimulation can be achieved through clothing. The coil is a non-sterile reusable device intended for multipatient use. The coil is transportable and is intended to be used in a laboratory, consulting room or equivalent environment. The coil is intended for short-term patient contact where single or cumulative contact does not exceed 24 hours.

The provided text is a 510(k) Summary for the Magstim D702 Coil, a medical device for peripheral nerve stimulation. It details how the device is considered substantially equivalent to predicate devices, primarily through engineering and performance testing, rather than studies involving human readers or extensive clinical trials.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Interpretation of "Acceptance Criteria": In this context, the "acceptance criteria" are not explicitly stated as numerical thresholds for success (e.g., "must achieve X% accuracy"). Instead, the acceptance criteria are implicitly defined by demonstrating that the modified device (Magstim D702 Coil) is substantially equivalent to the predicate devices. This means that:

• Its intended use and indications for use are the same.
• Its technological characteristics are similar, and any differences do not raise new questions of safety or effectiveness.
• Testing shows performance is comparable or improved and meets applicable safety standards.

The specific performance metrics for inductance, peak magnetic field, and number of pulses before overheating are compared directly to the predicate device's characteristics, and the device is deemed acceptable if these differences are understood and do not negatively impact safety or effectiveness, or in some cases, show improvement (e.g., higher pulse count due to better heat dissipation).

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

The document does not describe "test sets" in the context of patient data or clinical imaging. The "testing activities" mentioned involved:

• Safety testing from risk analysis.
• Laboratory studies for electrical safety testing.
• EMC testing.
• Usability testing for consumer accuracy (this might involve human interaction but isn't elaborated as a clinical study).
• Magnetic field measurement testing.

Therefore, there is no stated sample size for a patient test set or data provenance because the evaluation was primarily engineering and performance-based, comparing device specifications to a predicate. It was not a study involving patient data.

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

Not Applicable. The evaluation was engineering-focused. There was no "ground truth" derived from expert consensus on medical images or clinical outcomes from a patient test set.

4. Adjudication Method for the Test Set

Not Applicable. As there was no patient test set requiring expert interpretation or consensus, there was no adjudication method used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. The document does not describe an MRMC study. The comparison is between the new device and predicate devices based on engineering specifications and laboratory testing, not human reader performance with or without AI assistance.

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

Not Applicable. This device is a hardware component (a stimulating coil) for a medical stimulator, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The device's 'performance' is its ability to generate magnetic fields and deliver pulses according to its specifications.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance characteristics and safety profiles of the legally marketed predicate devices, along with relevant international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1). The new device's performance was measured against these benchmarks through laboratory testing.

8. The Sample Size for the Training Set

Not Applicable. As this is a hardware device and not an AI/ML algorithm that requires training data, there is no "training set."

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

Not Applicable. See point 8.

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The Neurosign Avalanche nerve monitor is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery.

The intended uses of the Neurosign Avalanche Motor Nerve Monitor is:

2 channel thyroidectomy and parathyroidectomy, mastoidectomy

parotidectomy, mastoidectomy, skull-base 4 channel

The Neurosign Avalanche Motor Nerve Monitor is a 2 or 4 channel nerve monitor for intraoperative use in general surgery, skull-base surgery and ENT. The Neurosign Avalanche Motor Nerve Monitor allows the user to detect motor nerves and to check their integrity by acquiring the compound muscle action potentials at the target muscles. The acquired signals are processed by the monitor and displayed as waveforms on the monitor screen and played back acoustically via the built in audio amplifier and loudspeaker.

The Neurosign Avalanche Motor Nerve Monitor provides additional information to the user, helping the surgeon to locate nerves by using an electrical stimulator. The sound is independent from the waveform display on the monitor's screen.

The displayed waveforms can be printed along with the patient information via the built in thermal array printer, or as a generated report in Word format.

The provided document describes the Neurosign Avalanche Motor Nerve Monitor and establishes its substantial equivalence to a predicate device, the Neurosign 400. However, it does not contain a comprehensive study with acceptance criteria and detailed device performance results in the format requested. The document focuses on comparing the features and intended uses of the new device to the predicate device in a non-clinical setting.

Here's an analysis of the provided text with respect to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, it relies on a comparison of features and intended use to establish substantial equivalence. The "Non-Clinical Tests Undertaken" section (Section 5.4) lists features that were found to be "similar."

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

The document explicitly states that the assessment was conducted in a "non-clinical setting" (Section 5.4). This means there was no patient data, and therefore no "test set" in the traditional sense of a clinical study. The comparison was based on the functional and technical specifications of the devices.

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

Since no clinical study or test set with patient data was involved, there was no need for experts to establish ground truth or interpret results. The comparison was based on engineering and design specifications.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set or clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence, which primarily relies on technological comparison and intended use, not clinical efficacy studies demonstrating improvement for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device is a medical instrument (nerve monitor) used in real-time by a surgeon "with human-in-the-loop," meaning a standalone algorithmic performance isn't applicable in the context of this device. The information it provides is directly interpreted and used by the surgeon.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the manufacturer's own documentation of the technical specifications, design, and intended use of both the predicate device and the new device. There is no external "ground truth" such as pathology, expert consensus, or outcomes data mentioned for this substantial equivalence submission.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense.

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

Not applicable, as there was no training set.

In summary:

This 510(k) submission (K083242) for the Neurosign Avalanche Motor Nerve Monitor relies on a non-clinical comparison of technical specifications and intended use against a previously cleared predicate device (Neurosign 400). It establishes "substantial equivalence" based on these comparisons rather than presenting clinical study data with acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop performance metrics. The document explicitly states that both devices were "assessed in a non-clinical setting and were determined to be similar."

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The Magstim® Double 70mm Air Film™ Coil is a stimulating coil solely intended for use with the Magstim® Rapid2 Stimulating Unit for the purposes of peripheral nerve stimulation. The coil is an accessory of the Magstim® Rapid2 Unit.

The Magstim Double 70mm Air Film Coil is an air-cooled coil intended for peripheral stimulation of the nerves. This coil enables deep, and otherwise inaccessible, nerves to be stimulated easily and relatively painlessly. Additionally, no skin preparation is required and stimulation can be achieved through clothing. The Magstim Double 70mm Air Film Coil is for use by, or under the supervision of, a medical practitioner only.

The provided text is a 510(k) submission for the Magstim® Double 70mm Air Film™ Coil. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested items (e.g., acceptance criteria for reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) because the submission's purpose is not to evaluate the diagnostic or treatment effectiveness of an AI/ML model.

This submission is for a physical medical device (a stimulating coil) that is an accessory to another device. Its clearance is based on demonstrating that it is as safe and effective as existing legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text:

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

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

• N/A. This submission does not involve a "test set" in the context of evaluating an AI/ML model's performance on clinical data. The comparison is based on device specifications and intended use.

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)

• N/A. No ground truth established by experts for a test set in this context.

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

• N/A. Not applicable, as there is no test set for clinical performance evaluation.

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

• N/A. No MRMC study was conducted. This is a physical device, not an AI/ML diagnostic or assistive tool.

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

• N/A. Not applicable, as this is not an algorithm.

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

• N/A. Not applicable, as there is no ground truth generation in the context of clinical performance evaluation for this device. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• N/A. Not applicable, as this is not an AI/ML device requiring a training set.

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

• N/A. Not applicable.

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Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.

The Neurosign® Laryngeal Electrode, which was specially developed for use with the Neurosign® 100, 400 and 800 models, consists of: a single-use electrode constructed from medical-grade inks suspended in a polyester substrate; a connector made of polypropylene; and a cable assembly. The electrode is available in two sizes to suit different sexes and age groups. The 6/7mm electrode should be used with a 6 or 7mm endotracheal tube; the 8/9mm electrode should be used with an 8 or 9mm tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately.

Using the laryngeal electrode lowers the risk of damage to the laryngeal or Xth cranial nerve (the Vagus nerve) during thyroidectomy or parathyroidectomy and, since it is noninvasive, it also lessens the risk of infection during the monitoring procedure.

The Neurosign® Laryngeal Electrode is a device intended for intraoperative monitoring of laryngeal nerves during thyroid surgery and the Xth cranial nerve (Vagus nerve) during skull-base surgery. The device consists of a single-use electrode attached to an endotracheal tube, which then connects to a Neurosign® machine for EMG readout.

The submission does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) of the device. Instead, the FDA's clearance is based on a determination of substantial equivalence to predicate devices. This means that the Neurosign® Laryngeal Electrode is considered as safe and effective as existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission based on substantial equivalence, there are no predefined numerical acceptance criteria or reported performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy) as would be found in a clinical study evaluating diagnostic performance. The "acceptance" is based on the device having similar characteristics, intended use, and safety/effectiveness profiles to the predicate devices.

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

This document does not describe a clinical study with a "test set" for performance evaluation in the typical sense of diagnostic or AI device studies. The clearance is based on substantial equivalence to existing devices. Therefore, there is no sample size for an independent test set or information on data provenance.

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

Not applicable, as no clinical study with a "test set" requiring expert-established ground truth is described in this submission.

4. Adjudication method for the test set:

Not applicable, as no clinical study with a "test set" and adjudication is described.

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 laryngeal electrode for nerve monitoring, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

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

Not applicable. This device is a physical electrode used in conjunction with a nerve monitor, not an algorithm.

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

Not applicable. The basis for clearance is substantial equivalence based on technical characteristics and intended use, not a clinical trial with a ground truth established by expert consensus or other clinical endpoints.

8. The sample size for the training set:

Not applicable. This device is a physical electrode, not a machine learning algorithm.

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

Not applicable. This device is a physical electrode, not a machine learning algorithm.

Summary of the "Study" (Basis for Acceptance):

The "study" or basis for acceptance in this 510(k) submission is a comparison to predicate devices to demonstrate substantial equivalence. The manufacturer, The Magstim Company Ltd., compared the Neurosign® Laryngeal Electrode to two predicate devices:

• Neurovision LSE500 Laryngeal Surface Electrodes (K003745)
• Medtronic NIM™ EMG Endotracheal Tube (K925640)

The comparison focused on technical characteristics, intended use, and safety features. The conclusion drawn by the manufacturer (and accepted by the FDA for clearance) is that the Neurosign® Laryngeal Electrode is "both safe and is similar in its risks and benefits, as well as its manner of performance, to the predicate devices." This substantial equivalence determination means the new device is considered as safe and effective as the predicate devices that are already legally marketed. No new clinical trials demonstrating specific performance metrics for the Neurosign® Laryngeal Electrode were necessary for this type of submission.

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Stimulation of Peripheral Nerves.

This submission is being made because the Magstim Company, referred to as Magsimil, has mounted the device marked under K992911 to replace the external laptop interfaced with the main system via a computer with an embedded interest. Previously, a laptop interfaced with the main bespoke touch-screen display moduler. The new system architecture means that unnt via the I CNCD I V or of also ove controlling the system, resulting in it no longer there is dedicated, in-nouse, so Microsoft Windows operating environment. The requiring all external laptop of Interesses wo and four booster modules, which has been replaced with single and dual module power supplies in the Rapid'. 2001 has been replaced with single are of coils are also introduced with this 510(k), generation contral Magstim Rapid coil family in K992911 can be used with the Rapid2, and the differenced between the 2nd generation and the original coils do not Rapid , and the unrelemed between ss. The intended use of the Magstim Rapid2 and Talse Issues of Salery and Chrostrents in K992911, and the frequency output has been Magstin Super Rapid '15 the Same as also as a power levels, which is consistent with the Changed High Speed Magnetic Stimulator in K905059.

The provided document is a 510(k) summary for the Magstim Rapid2 and Magstim Super Rapid2 devices. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study designed to establish new acceptance criteria or device performance through a standalone clinical trial with statistically significant outcomes against predefined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are not available in this document.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study. Instead, it compares the technical specifications and performance characteristics of the new devices (Magstim Rapid2 & Magstim Super Rapid2) against predicate devices (Magstim Rapid K992911 and Cadwell High Speed Magnetic Stimulator K905059) to demonstrate "substantial equivalence." The "performance" reported is essentially the device's technical specifications.

The "acceptance criteria" here is implicitly demonstrating that the new devices' specifications meet or exceed the performance of legally marketed predicate devices, thus ensuring they are equally safe and effective for their intended use.

Specific Study Information:

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

   • Not applicable / Not provided. This document does not describe a clinical study with a "test set" of patients or data in the context of a diagnostic or treatment effectiveness study where such metrics are typical. The evaluation is based on technical specifications and engineering tests. Data provenance for such engineering tests is not specified, but it would have been conducted by the manufacturer, Magstim Company Limited (UK).

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

   • Not applicable / Not provided. No "ground truth" in the clinical sense (e.g., disease diagnosis) was established by experts for a test set in this 510(k) summary. The "ground truth" for the device's technical performance would be objective measurements and engineering standards.

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

   • Not applicable / Not provided. No adjudication of clinical data was performed as no clinical "test set" was described.

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 / Not provided. This is not an AI-assisted diagnostic device, and no MRMC study was conducted or described.

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

   • Not applicable / Not provided. This is an electromagnetic stimulator, not an algorithm, and no standalone performance study in this context was described. The "standalone" performance here relates to the technical specifications of the device itself.

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

   • Not applicable / Not provided for clinical ground truth. The "ground truth" for this submission are the technical specifications and performance characteristics of the predicate devices and the new devices, as measured and verified through engineering and bench testing. These include parameters like field strength, frequency, train duration, etc., as shown in the tables.

7. The sample size for the training set:

   • Not applicable / Not provided. As this is not an AI/machine learning device, there is no "training set."

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

   • Not applicable / Not provided. No training set exists for this type of device.

Overall Conclusion from the document:

The submission focuses entirely on substantial equivalence to predicate devices through technical comparisons and engineering performance data. The FDA agreed that "Software documentation and testing, environmental and EMC testing, as well as on measurements where provided to demonstrate safety and performance" were sufficient to establish this. No clinical studies are mentioned.

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To locate and identify cranial motor nerves during ENT and intra-cranial procedures.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Neurosign Nerve Monitor." This document focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain information about acceptance criteria, detailed study results, sample sizes, expert qualifications, or ground truth establishment that would allow me to answer your request.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the approval is based on comparison to existing devices, not necessarily a new, detailed performance study with the specific metrics you requested.

Therefore, I cannot provide the information you asked for based on the input text.

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The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.

The Neurosign 400 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular, or surface, electrodes are attached for EMG recordings. Additionally, connected to the main unit is a stimulator pod to which a stimulating probe, which delivers current to nerve tissue, may be connected. The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.

Here's an analysis of the provided text regarding the Neurosign 400 Motor Nerve Monitor, focusing on acceptance criteria and the study proving its effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document extensively describes the Neurosign 400 as being "similar" to previously cleared devices (Neurosign 800 and Neurosign 100), and relies heavily on the safety and effectiveness history of these predicate devices. The acceptance criteria aren't explicitly quantified with specific performance metrics (e.g., minimum accuracy percentages, sensitivity, specificity). Instead, the criteria are qualitative and based on equivalence and lack of adverse events from predicate devices.

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

The document does not specify a test set sample size or describe any specific clinical study involving a "test set" in the traditional sense of a new, independent dataset for evaluation.

Instead, the safety and effectiveness are established through:

• Historical data of predicate devices: Review of complaints and adverse events for the Neurosign 800 and Neurosign 100. The provenance is implied to be historical market data from the U.S. and potentially other regions where these devices were distributed. This is retrospective data.
• In-house and on-site clinical evaluation: Performed by The Magstim Company for "all its products, both prior to, and after product release for distribution." The data provenance for these internal evaluations is not detailed (e.g., country of origin, retrospective/prospective).

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

No specific "test set" with ground truth established by external experts is described. The acceptance relies on:

• Market feedback on predicate devices: The absence of reported adverse events or complaints is implicitly the "ground truth" for proving safety and effectiveness of the existing technology.
• Internal "team participation" for evaluations: "Team members include, but are not limited to Marketing, Manufacturing, Engineering and Quality Assurance." While these individuals are experts in their respective fields, they are internal to the company and not independent clinical experts establishing ground truth for a defined test set. Their qualifications are not specified beyond their departmental roles.

4. Adjudication Method for the Test Set:

No specific test set or adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as there was no formal independent clinical study with a predefined test set and expert review for this 510(k) submission. Acceptance is based on the lack of complaints for predicate devices and internal company evaluations.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is presented or referenced. The submission does not involve comparing human reader performance with or without AI assistance, as the device is a nerve monitor/stimulator and not an AI-driven image analysis tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This detail is not applicable in the context of the Neurosign 400. The device is an EMG machine and nerve stimulator designed for direct use by a clinician during surgical procedures. Its functionality is not based on a standalone algorithm or AI performance that would be evaluated without human interaction. The "performance" is its ability to accurately detect EMG activity and stimulate nerves, which is inherently part of a human-in-the-loop diagnostic/monitoring process.

7. The Type of Ground Truth Used:

The ground truth mainly relies on:

• Historical safety and effectiveness data of predicate devices: Absence of adverse events and complaints for Neurosign 800 and Neurosign 100. This is essentially "outcomes data" in a broad sense, demonstrating safe and effective use in real-world clinical practice over time.
• Internal company specifications and expectations: The device passed internal evaluations against established product specifications.

8. The Sample Size for the Training Set:

The document does not describe a "training set" in the context of machine learning or algorithm development. The device's functionality is based on established electrophysiological principles and hardware design, not on a data-driven learning model. Therefore, sample sizes for training sets are not applicable or mentioned.

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

As there is no described training set for an algorithm, the concept of establishing ground truth for a training set is not relevant to this 510(k) submission. The safety and effectiveness are established through substantial equivalence based on the history of predicate devices and internal validation processes.

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To locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots.

Neurosign 800. 8 Channel Motor Nerve Monitor

This document is an FDA 510(k) clearance letter for the Neurosign 800, 8 Channel Motor Nerve Monitor, dated August 5, 1998. The letter states that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory correspondence does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving device performance.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Details on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Description of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is primarily for regulatory clearance and focuses on the substantial equivalence determination. To find the information you're looking for, you would typically need to refer to the 510(k) premarket notification submission itself or potentially peer-reviewed publications related to the device, which are not provided here.

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The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

The Neurosign 800 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular or surface electrodes are attached for EMG recordings. Additionally connected to the main unit is a stimulator pod to which a stimulating probe which delivers current to nerve tissue may be connected.

This 510(k) submission for the Neurosign 800 Motor Nerve Monitor does not contain the kind of detailed information about acceptance criteria and a specific study proving it meets those criteria that is typically found in submissions for AI/ML-driven medical devices.

The provided text focuses on:

• Device Description: What the Neurosign 800 is and how it works.
• Intended Use: Monitoring and stimulating cranial motor nerves.
• Substantial Equivalence: Listing similar predicate devices (Neurosign 100, Brackmann II, NIM-2XL).
• Safety and Effectiveness Justification (General):
  • Lack of complaints/adverse effects for predicate devices.
  • "Extensive in-house and on-site clinical evaluation" of all products by The Magstim Company.
  • Statement that the Neurosign 800 "has met all specifications and expectations for its intended use based on the evaluations conducted thus far."
  • Consistency in manufacturing methods with a predicate device.
  • Conclusion that it is "safe and effective for its intended use."

It explicitly states: "The Magstim Company performs extensive in-house and on-site clinical evaluation of all its products both prior to and after product release for distribution. Our methods and procedures for acceptance of products as well as our techniques for clinical evaluation are performed using team participation. ... The Neurosign 800 has met all specifications and expectations for its intended use based on the evaluations conducted thus far."

This is a very general statement and does not provide the specific details requested in your prompt, which are more geared towards validating the performance of an algorithm or an AI model against quantifiable metrics.

Therefore, for your specific questions, based only on the provided text, the answer is that this information is not available or not described in the given 510(k) summary.

Here's a breakdown of how the information you requested maps (or doesn't map) to the provided text:

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

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The evaluations are described as "in-house and on-site clinical evaluation." Whether these were formal studies with defined test sets, controlled environments, or specific data collection methodologies (prospective/retrospective) is not detailed.

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)

• Not specified. The "team participation" mentioned includes Marketing, Manufacturing, Engineering, Clinical Engineering, Manufacturing Engineering, and Quality Assurance, which are involved in "methods and procedures for acceptance of products" and "techniques for clinical evaluation." This is a product development team, not necessarily a panel of independent clinical experts establishing ground truth for a test set.

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

• Not specified.

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/Not specified. This device is a nerve monitor and stimulator, not an AI-driven diagnostic tool that assists human readers in interpreting images or data in the way an AI algorithm might. The summary does not mention any AI component or human-in-the-loop assistance for interpretation.

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

• Not applicable/Not specified. This is a hardware device with associated software for signal acquisition and display, not an algorithm performing a diagnostic or predictive function independently.

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

• Not specified. Given the nature of an EMG and stimulator, typical "ground truth" might relate to direct observation of nerve stimulation response, correlation with surgical findings, or clinical neurological assessment, but this is not detailed in the summary.

8. The sample size for the training set

• Not applicable/Not specified. This device does not describe an AI/ML component that uses a "training set."

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

• Not applicable/Not specified.

In summary: The provided 510(k) refers to general internal company evaluations and clinical assessments that led to the conclusion of safety and effectiveness, drawing heavily on substantial equivalence to predicate devices and their unblemished safety record. It does not contain the detailed, quantitative study data or acceptance criteria typically provided for AI/ML device submissions, or even for non-AI devices where specific performance claims (e.g., accuracy, precision) need to be validated in a formal study.

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