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The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

The UltraPro S100 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities.

The UltraPro S100 system consists of the following major components:

• Main unit (also known as base unit or main base unit) with integrated control panel; ●
• Amplifier (3- or 4-channel);
• . Computer- laptop or desktop (with keyboard and mouse)
• Display Monitor (for desktop system)
• . Application Software (Natus Elite)

The UltraPro S100 has the following optional accessories/ components:

• Audio stimulators (Headphones or other auditory transducers)
• Visual stimulators (LED goggles or stimulus monitor)
• . Electrical stimulators (RS10 probes, stimulus probe with controls)
• Cart and associated accessories when using cart such as isolation transformer
• Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc.

The electrodiagnostics system is powered by a connection to mains.

The entire user interface of UltraPro S100 system consists of two major elements:

• The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite.
• The second means of interaction is the user interface elements on the hardware.

The UltraPro S100 is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The provided text is a 510(k) Summary for the Natus Ultrapro S100 device. While it describes the device's indications for use and compares its technological characteristics to predicate devices, it does not contain information about the acceptance criteria or the specific study that proves the device meets those criteria, such as a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. This document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and intended use.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used for test/training sets, data provenance, number or qualifications of experts, adjudication methods, or details about MRMC or standalone studies based on the provided text. The document is primarily a comparison of features and intended use.

The "Conclusion" section on page 14 states: "Verification and validation activities were conducted to establish the performance and safety characteristics of the UltraPro S100. The results of these activities demonstrate that the UltraPro S100 is safe, effective, and performance is substantially equivalent to the predicate devices." However, it does not elaborate on what these activities entailed or the specific criteria and results.

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The EyeStat is intended to measure and display the mechanically induced blink reflex. The device is intended to be used by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under the direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children.

The operating principle of the EyeStat device is that the application of a light puff of air (sterile food grade CO2) to the outer canthus of the eye acts as a stimulus that elicits a blink reflex. The puff of air is delivered while the patient's eyes are positioned within an eyepiece that allows the movement of the eye lid to be tracked using two high-speed cameras. The device uses software to evaluate the video frames containing the movement of the eyelid of the eye to which the puff of air was applied (ipsilateral) and detect the frame containing the initiation of a blink using image/video processing algorithms. The time associated with the video frame containing the initiation of the ipsilateral blink is then compared to the time associated with the application of the puff of air, and the difference represents the latency.

Here's an analysis of the acceptance criteria and study detailed in the provided text.

Based on the provided text, the device in question is the EyeStat, an "Evoked Response Mechanical Stimulator" intended to measure and display the mechanically induced blink reflex.

The available information describes the general performance testing and does not provide typical acceptance criteria in specific numerical thresholds (e.g., Sensitivity > X%, Specificity > Y%) for blink reflex measurements. Instead, the performance evaluations focus on the functionality and accuracy of the device's components and measurements.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Accuracy (Eye Lid Tracking): Not explicitly stated. The text only mentions "an expert reviewer" and does not provide the number of cases or data provenance.
• Precision: Not explicitly stated. The text reports "test-retest reliability of all measurements," but the sample size for patients or measurements is not given, nor is the data provenance.
• Pressure of Stimulus: The text mentions comparing the EyeStat's air pressures against a non-contact tonometer (reference device). It does not specify the sample size of these comparisons or their provenance.

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

• Accuracy (Eye Lid Tracking): "an expert reviewer" was used. No specific qualifications (e.g., years of experience, specialty) for this expert are provided.

4. Adjudication Method for the Test Set

• The text does not describe any specific adjudication method (e.g., 2+1, 3+1). For eye-lid tracking accuracy, it appears to be a direct comparison against a single expert's contouring, rather than a consensus approach.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study was not described. The provided text focuses on the device's intrinsic performance characteristics and comparison to elements of a predicate device but does not mention a study evaluating human readers' improvement with or without AI assistance.

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

• Yes, a standalone study was implicitly done for "Accuracy (Eye Lid Tracking)." The algorithm's eye-lid tracking performance was compared against an expert's contouring, which assesses the algorithm's capability independently of a human operator, at least for that specific function. The "Precision" testing also appears to be standalone, evaluating the device's inherent measurement consistency.

7. The Type of Ground Truth Used

• Accuracy (Eye Lid Tracking): Expert contouring/review served as the ground truth.
• Precision: The "ground truth" for precision is implicitly the device's own repeat measurements, aiming for high consistency.
• Pressure of Stimulus: A "non-contact tonometer device" (a reference device, K802419) was used for comparison, implying its measurements served as a benchmark for the stimulus pressure.

8. The Sample Size for the Training Set

• Not specified. The document does not provide any information about a training set or its sample size. This is common if the algorithm development process is not detailed, or if a specific "training set" in the machine learning sense was not explicitly defined or reported in the regulatory submission.

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

• Not applicable / Not specified. Since no information regarding a training set is provided, how its ground truth was established is also not detailed.

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The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general. Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Natus VikingQuest is intended to be used by a qualified healthcare provider.

The Natus VikingQuest is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.

The provided text describes the 510(k) premarket notification for the Natus VikingQuest, a diagnostic electromyograph. The information focuses on its substantial equivalence to predicate devices and adherence to various medical device standards. However, it does not contain specific details about acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test sets, data provenance, ground truth establishment, or clinical study designs (like MRMC or standalone performance).

The document primarily outlines the regulatory compliance, technological characteristics, and intended use of the device, rather than detailed clinical performance evaluations against specific acceptance criteria.

Therefore, for aspects related to acceptance criteria and a study proving device performance, the information is largely absent in the provided text.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified. The document describes engineering and regulatory compliance testing rather than clinical study data.

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 test set or ground truth establishment by experts for performance against a diagnosis is described. The "ground truth" mentioned pertains to compliance with engineering and safety standards.

4. Adjudication method for the test set:

• Not applicable as no human adjudication of clinical results 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:

• No mention of an MRMC study or AI assistance. The Natus VikingQuest is a diagnostic electromyograph for acquiring, displaying, analyzing, and reporting electrophysiological information, not an AI-driven interpretation system.

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

• The document describes a medical device (electromyograph) for use by a qualified healthcare provider. It does not describe a standalone algorithm or AI performance. The performance verified is for the entire device as a system.

7. The type of ground truth used:

• For the regulatory and engineering tests (biocompatibility, software, electrical safety, EMC, usability), the "ground truth" is compliance with established international standards (ISO, IEC, AAMI/ANSI) and FDA guidance documents. There is no mention of pathology, expert consensus on clinical findings, or outcomes data in the context of the device's diagnostic accuracy proving.

8. The sample size for the training set:

• Not applicable. The document describes a medical device, not an AI/machine learning algorithm with distinct training and test sets in the typical sense. Software development was "rigorously verified and validated consistent with FDA guidance documents and standards," implying traditional software testing, not machine learning model training.

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

• Not applicable, for the same reasons as point 8.

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Cadwell Sierra Summit:

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Cadwell Sierra Ascent:

Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.

The Sierra Summit provides a variety of test protocols spanning the various test modalities above.

The Cadwell Sierra Summit consists of the following major components:

• Sierra Summit console base unit with integrated control panel ●
• Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
• Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
• Display monitor ●
• Summit software

The Sierra Summit has the following optional accessories/components:

• Remote Head Box (for 3-12 channel amplifier) ●
• StimTroller (Hand Held Electrical Stimulator)
• Electrical Stimulator Switch Box ●
• Footswitch (single) ●
• Visual Stimulators (LED Goggles, LCD Checks)
• VEP Calibration Sensor
• Headphones or other auditory transducers
• Reflex Hammer
• Temperature Probe ●
• Cart
• Isolation Transformer or Medical Grade Power Strip
• Printer

The provided text is a 510(k) Summary for the Cadwell Sierra Summit and Cadwell Sierra Ascent devices. It details the device descriptions, indications for use, and a summary of technical characteristics compared to predicate devices, along with performance testing. However, it does not include specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) or detailed results from studies designed to prove the device meets such criteria.

The "Performance Testing - Bench" section mentions conformance to various standards and internal requirements, concluding that "Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards." This is a general statement of compliance, not a presentation of performance data against specific acceptance criteria.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

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

This information is not provided in the document. The document states compliance with "predetermined specifications and applicable standards" for various tests (biocompatibility, software, electrical safety, EMC, and bench performance), but it does not list specific numerical acceptance criteria or quantitative performance results for the device.

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

This information is not provided in the document. The document describes "Performance Testing - Bench" and "Verification and validation activities," but it does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective).

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):

This information is not provided in the document. The document refers to the device being used by "qualified medical practitioners" for diagnosis but clarifies that the device "does not provide any diagnostic conclusion about the patient's condition to the user." There is no mention of experts establishing ground truth for any test sets related to diagnostic performance.

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

This information is not provided in the document. There is no mention of an adjudication method.

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:

This information is not provided in the document. The device is a diagnostic electromyograph for measuring electrophysiological data and supporting the diagnosis of neuromuscular diseases. It is not described as an AI-assisted device for interpretation or diagnosis to be used "with AI vs without AI assistance" by human readers in the context of improving effectiveness. The document states, "This device does not provide any diagnostic conclusion about the patient's condition to the user."

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

This information is not provided in the document. Given the nature of the device (electromyograph for data acquisition and analysis, not providing diagnostic conclusions), it typically functions as a tool for a human practitioner, rather than as a standalone diagnostic algorithm.

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

This information is not provided in the document. As no specific performance studies against a diagnostic "ground truth" are detailed, the type of ground truth is not mentioned.

8. The sample size for the training set:

This information is not provided in the document. No training data or training set sample size is mentioned, as the device is not an AI/machine learning model in the sense of requiring a training set for diagnostic outcome prediction.

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

This information is not provided in the document. As no training set is mentioned, the method for establishing its ground truth is also not.

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The Synergy Focus is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Synergy Focus may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Synergy Focus is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Synergy Focus is intended to be used by a qualified healthcare provider.

The Natus Synergy Focus (Synergy Focus) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy Focus provides a variety of tests spanning the various modalities.

The Synergy Focus consists of the following major components:

• Console base unit with integrated control panel;
• Amplifier (with three non-switched amplifier channels);
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Synergy Software.

The Synergy Focus optional accessories/components consists of the following:

• Stimulator probes (RS 10 probe, Stimulus Probe with controls)
• Footswitches (triple)
• LED goggles
• Headphones or other auditory transducers
• Patient response button
• Cart
• Isolation transformer
• Printer.

The Natus Synergy Focus is an electromyograph (EMG) device intended for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance relies heavily on demonstrating substantial equivalence to predicate devices (K112052 CareFusion Nicolet EDX with Viking Software and K120979 CareFusion Nicolet EDX with Synergy Software). Therefore, the "acceptance criteria" are primarily defined by the performance characteristics of these predicate devices, and the "reported device performance" demonstrates that the Synergy Focus either matches or improves upon these characteristics, or where there are differences, they do not raise new questions of safety or effectiveness.

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

The provided 510(k) summary does not explicitly state a sample size for a test set or data provenance in the context of clinical performance or AI/algorithm performance.

Instead, the submission relies on demonstrating substantial equivalence to its predicate devices (K112052 and K120979) through:

• Comparison of technical characteristics.
• Non-clinical performance testing (biocompatibility, software validation, electrical safety, EMC, and bench testing to applicable standards like IEC 60601-2-40).
• The explicitly stated conclusion that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness."

This indicates that there was no separate "test set" of patient data used for evaluating the performance of the Synergy Focus in a clinical or AI context, as its performance is considered equivalent due to identical or functionally equivalent hardware and software to already cleared devices.

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

Since no clinical or AI-specific test set was used requiring ground truth establishment by experts, this information is not applicable to this 510(k) submission.

4. Adjudication Method for the Test Set

As no test set involving human interpretation requiring adjudication was used, this information is not applicable.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness," and the device is a diagnostic electromyograph, not an AI-assisted diagnostic tool in the sense of image interpretation. Therefore, there is no AI assistance improvement effect size to report.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on an algorithm's performance without human-in-the-loop was not done. The Synergy Focus is a hardware and software system for acquiring and displaying physiological signals, not a standalone algorithm providing diagnostic outputs. The software component, categorized as "MODERATE level of concern," underwent rigorous verification and validation during development, as noted in the "Software testing" section, but this is distinct from an AI algorithm's standalone performance study.

7. Type of Ground Truth Used

Given the nature of the device and the submission's focus on substantial equivalence through technical characteristics and non-clinical testing, there was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of evaluating the diagnostic accuracy of a new algorithm or clinical performance. The ground truth (or reference standard) in this submission relates to:

• Engineering specifications and standards: The device's performance was compared against the technical specifications of the predicate devices and national/international standards (e.g., IEC 60601-2-40 for safety and performance of electromyographs).
• Predicate device characteristics: The primary "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the Nicolet EDX with Viking and Synergy software systems.

8. Sample Size for the Training Set

Since there is no mention of an AI algorithm or machine learning component in this submission that would require training data, information regarding the sample size for a training set is not applicable. The software validation focused on standard software development lifecycle testing (verification and validation of pre-determined specifications), not on training a model.

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

As there was no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

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The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Synergy Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Synergy Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcare provider.

The CareFusion Nicolet EDX system with Synergy Software (Synergy EDX) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy EDX provides a variety of tests spanning the various modalities.

The Synergy EDX consists of the following major components:

• Nicolet EDX console base unit;
• Synergy control panel:
• Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels;
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Synergy Software

The Synergy EDX optional accessories/components consists of the following:

• Nicolet HB6 or HB7 Head Box
• Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe)
• SP1/SP2 electrical stimulator switching units
• Footswitches (single and triple)
• LED goggles
• Patient response button
• Photic strobe
• Headphones or other auditory transducers
• Cart
• Isolation transformer
• Printer

This document is a 510(k) Summary for the CareFusion Nicolet EDX with Synergy Software. It primarily serves to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with detailed acceptance criteria and results from a clinical trial or a structured validation study as one might expect for a novel AI/ML device.

Here's an analysis based on the provided text, addressing your points:

The Device: The CareFusion Nicolet EDX with Synergy Software is a diagnostic electromyograph system designed for acquiring, displaying, analyzing, reporting, and managing electrophysiological information from human nervous and muscular systems. It performs nerve conduction studies (NCS), needle electromyography (EMG), evoked potential (EP) testing, and intra-operative monitoring (IOM).

Overview of Acceptance Criteria and Performance (Based on Substantial Equivalence):

This submission is a 510(k) for substantial equivalence, not a new de novo device with specific clinical performance acceptance criteria against a ground truth. The acceptance criteria essentially revolve around demonstrating that the new device has the same technological characteristics, indications for use, and safety/effectiveness as its predicate devices, or that any differences do not raise new questions of safety or effectiveness.

The document primarily shows that the CareFusion Nicolet EDX with Synergy Software is "Identical" or "Similar" to its predicate device, the CareFusion Nicolet EDX with Viking software (K112052), with one minor addition (CNV test to EP modality) and one minor difference in auditory tone frequency that doesn't change indications for use or safety/effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission relying on comparison to a predicate, the "acceptance criteria" are implied by the similarity to the predicate, and "performance" is demonstrated by showing these similarities through technical specifications, rather than new quantitative performance metrics.

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The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP). The Nicolet EDX with Viking Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Viking Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Nicolet EDX with Viking Software is intended to be used by a qualified healthcare provider.

The CareFusion Nicolet EDX system with Viking Software (Viking EDX) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). The system can also perform multi-modality recording through Multi-mode programs (MMP). Viking EDX provides a variety of tests spanning the various modalities.

The Viking EDX consists of the following major components:

• Nicolet EDX console base unit;
• Viking control panel;
• Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels;
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Viking Software.

The Viking EDX optional accessories/components consists of the following:

• Nicolet HB6 or HB7 Head Box
• Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe)
• SP1/SP2 electrical stimulator switching units
• Footswitches (single and triple)
• LED goggles
• Patient response button
• Photic strobe
• Headphones or other auditory transducers
• Cart
• Isolation transformer
• Printer

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not contain a discrete list of "acceptance criteria" for the device's overall performance. Instead, it details the device's technical characteristics and claims substantial equivalence to predicate devices based on these characteristics and compliance with various recognized standards. The "reported device performance" is primarily indicated by successful completion of these compliance tests.

However, based on the comparative tables (pages 11, 12, 13) and the performance testing section (page 17), we can infer performance characteristics that are likely considered "met standards" or "acceptable." I will present the new device's (CareFusion Nicolet EDX System) performance characteristics in a table, as these are the "reported performance" that met the criteria for substantial equivalence, which implicitly means they met acceptance criteria (i.e., met or exceeded predicate device performance and regulatory standards).

CareFusion Nicolet EDX with Viking Software - Reported Device Performance against Implied Acceptance Criteria (via Predicate Comparison and Standards Compliance)

The study that proves the device meets (or exceeds) these acceptance criteria is detailed in the "Summary of Non-Clinical Performance Testing Conducted for the Determination of Substantial Equivalence" section on page 17.

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

• Sample Size: The document does not specify a "sample size" in terms of patient data for the performance testing. The performance testing section (page 17) refers to "bench testing" and compliance with standards.
• Data Provenance: The document explicitly states: "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness." (page 17). Therefore, there is no patient data provenance (country of origin, retrospective/prospective). The evidence relies on bench testing and comparisons to predicate devices, which are presumably based on established performance specifications and regulatory standards.

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

• Not applicable. As stated, animal and clinical testing were not performed. The "ground truth" for the device's technical performance was established by compliance with recognized engineering and safety standards (e.g., IEC, UL, ISO) and by demonstrating substantial equivalence to predicate devices. This implies that the technical specifications of the device met the established benchmarks of these standards and predicate devices, which were themselves cleared based on clinical utility and safety, likely informed by expert consensus in the field of electrophysiology. However, no specific "experts" were used to establish ground truth for a test set in this submission's performance evaluation.

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

• Not applicable. There was no clinical test set or human-in-the-loop experiment that would require an adjudication method by experts. The assessment was based on non-clinical performance (bench testing) and comparison to predicate devices against established standards.

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 diagnostic electromyograph and evoked potential system, not an AI-powered diagnostic tool requiring human-reader interpretation improvement studies. It is a hardware and software system for acquiring, displaying, and analyzing electrophysiological signals. The term "AI assistance" is not relevant to this device's stated functionality or evaluation.

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

• Yes, in a way. The performance testing described (biocompatibility, software testing, electrical safety, EMC, and bench performance testing) is essentially "standalone" testing of the device's components and system against predetermined specifications and international standards, without human interaction as part of the evaluation process, other than operators performing the tests. This confirms the inherent functional capabilities of the device itself.

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

• The ground truth used was primarily established technical specifications and international regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, UL 60601-1, ISO 10993-1) as well as the technical characteristics of legally marketed predicate devices. The device was deemed substantially equivalent because its performance met or exceeded these established benchmarks.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning product that requires a "training set" of data in the conventional sense. The "training" of the device refers to its design and development to meet functional requirements and standards, not a data-driven learning process.

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

• Not applicable, as there is no training set. The "ground truth" for the device's fundamental design and functionality was established by recognized engineering principles and adherence to medical device safety and performance standards.

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The B SMART Sensory Response Timer is indicated for use in evaluating neurological status during surgery under regional anesthesia by monitoring the capability of the patient to detect and to respond to a timed series of mechanical and auditory stimuli.

The B SMART Sensory Response Timer system consists of two components connected by an electrical cable. These components are a Control Unit and a Finger Attachment. The Control Unit contains a power supply, a cycle timer, an audio tone generator and speaker, and necessary controls, indicators, and connectors. The Finger Attachment contains a vibratory tactile stimulus mechanism and an impedance-pad-type cycle reset button housed in a small case which is attached to the patient's finger using a Velcro band. When the patient feels the vibratory stimulus (or hears the speaker tone), he or she presses the cycle reset button to terminate the stimuli. Cessation of the audio tone informs the attending physician or nurse that the patient is awake and able to respond. If the audio tone does not cease, the anesthesiologist is alerted that intervention may be needed due to impairment of neuromuscular responsiveness.

Here's a breakdown of the acceptance criteria and study information for the B SMART system, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the performance of the device rather than explicit, pre-defined acceptance criteria in a quantifiable table format. However, the study results implicitly define the device's acceptable performance. For clarity, I will interpret the reported outcomes as the de facto acceptance criteria demonstrated by the study.

Study Details:

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

   • Sample Size: 47 patients.
   • Data Provenance: The study was conducted by Buchbinder and Melick over a period of three years. The information does not explicitly state the country of origin, but the 81st Clinical Congress of the American College of Surgeons was held in New Orleans, LA, suggesting a U.S.-based study. The study appears to be prospective in nature, as it describes monitoring patients during actual surgical procedures.

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

   • The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
   • However, the study involved monitoring patients during carotid endarterectomy under regional anesthesia, where anesthesiologists and surgeons would be the primary clinicians overseeing patient neurological status and making decisions based on the device's feedback and their clinical judgment. "Neurological dysfunction was detected in three patients (6.4%) and was treated successfully by immediate insertion of a temporary shunt," suggesting clinical expert judgment was involved in confirming and acting on detected issues.

3. Adjudication method for the test set:

   • The document does not specify a formal adjudication method (e.g., 2+1, 3+1). The nature of the study seems to be direct clinical observation and intervention based on the device's output and the operating team's assessment.

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:

   • No, an MRMC comparative effectiveness study was not done. The B SMART system is a "patient-activated stimulus/response system" that monitors neurological status, not an AI-assisted diagnostic imaging tool with "human readers." The study focuses on the device's ability to monitor patient responsiveness during surgery.

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

   • The B SMART system is inherently a human-in-the-loop device. It relies on a patient's volitional response (pressing a button) to a stimulus. Therefore, a standalone "algorithm only" performance would not be applicable or clinically meaningful for this device's intended use. The device's function is to assess patient response, which requires the patient's active participation.

6. The type of ground truth used:

   • The ground truth appears to be clinical outcome/patient responsiveness during surgery, as assessed by the medical team. The detection of "neurological dysfunction" and subsequent "successful treatment by immediate insertion of a temporary shunt" indicates that actual clinical events and interventions served as the reference for the device's effectiveness in identifying issues.

7. The sample size for the training set:

   • The document does not mention a separate training set. The study cited (Buchbinder and Melick) describes the performance of a "prototype version" of the B SMART system, which suggests this was an evaluation of the device in its near-final or tested form, rather than a separate training phase. As a relatively simple mechanical/electrical device assessing a physiological response, it's unlikely to have relied on a "training set" in the way an AI/ML algorithm would.

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

   • Since no separate training set is described for an AI/ML algorithm, this question is not applicable.

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