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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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TECA™ ELITE Disposable Concentric Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

CareFusion 209, Inc. TECATM ELITE Disposable Concentric Needles (TECATM ELITE Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM ELITE Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user.

TECATM ELITE Needles consist of a stainless steel tube with a conductive core. A polyesterimide isolative coating resides between the core and the stainless steel tube. The exterior surface of the needle is dipped in a low-friction lubricant. TECATM ELITE Needles are passive devices, and do not contain electrical hardware components or software.

The following device modifications were made to the TECATM ELITE Needles: Modification of the core material; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the packaging materials.

The provided document is a Special 510(k) Premarket Notification for TECA™ ELITE Disposable Concentric Needles. This document details device modifications and performance testing for demonstrating substantial equivalence to a predicate device, rather than a study proving new acceptance criteria for a novel device or AI. As such, information regarding AI-specific criteria, human reader studies, or training set details will not be available.

Here's an analysis based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" as one might expect for a new device establishing clinical efficacy. Instead, it details verification and validation activities conducted to demonstrate that the modified device continues to meet its predetermined specifications and applicable standards. The acceptance criteria are implicitly derived from these standards and internal requirements.

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 does not specify sample sizes for any of the performance tests. The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are described as "Performance testing was performed on device characteristics... in accordance with internal requirements and the applicable portions of the following Standards." This implies the testing was conducted internally, likely prospective, to evaluate the specific modifications.

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 type of information is not relevant or included in the provided document. The device is a medical needle for electromyography, not an AI or diagnostic imaging device that requires expert interpretation for "ground truth" establishment in a clinical study context. The performance assessments are based on engineering standards and physical/electrical measurements.

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

Not applicable. This device's performance evaluation does not involve clinical interpretation or a "ground truth" to be adjudicated by multiple experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a passive, single-use needle electrode, not an AI system or an imaging modality that would involve a multi-reader multi-case study.

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

Not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering and biocompatibility standards (e.g., ISO 10993-1, ASTM F88, ASTM F1929, ISO 7864) and the predetermined specifications of the device itself and its predicate. There is no clinical or pathological "ground truth" in the traditional sense for these types of manufacturing and design verification tests.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable. As there is no training set for this device, a method for establishing its "ground truth" is irrelevant.

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TECA™ elite Disposable Monopolar Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

CareFusion TECAT™ elite Disposable Monopolar Needles (TECATM elite Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM elite Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user. TECAT™ elite Needles are stainless steel, platinum alloy, and/or gold plated stainless steel, and coated with a polytetrafluoroethylene (PTFE) insulator. A low-friction lubricant is applied to the exterior surface of the needle. TECAT™ elite Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECAT™ elite Needles: Reformulation of the PTFE exterior needle coating; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the needle tip geometry.

The provided text describes the 510(k) Premarket Notification for CareFusion's TECA™ elite Disposable Monopolar Needles. This document focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing the performance of a novel AI/ML device against specific acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, sample sizes, expert ground truthing, MRMC studies, or training sets is not applicable here.

However, I can extract information related to the device's characteristics and the testing performed to show its compliance.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on verifying that the modified TECA™ elite Needles comply with predetermined specifications and applicable standards, specifically referencing ISO 10993-1 for biocompatibility and ISO 7864 for performance. The "acceptance criteria" here are implied by these standards and the internal requirements, and the "reported device performance" is a general statement of compliance.

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

This is not applicable as the study described is a device modification verification, not a clinical study with a specific test set of patient data. The testing involved bench performance and biocompatibility assessments of the physical device and its materials.

3. Number of Experts Used to Establish the Ground Truth and Qualifications of Those Experts

This information is not provided and is not applicable to the type of device verification described. Ground truth for clinical outcomes or diagnostic accuracy by experts is not relevant here.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves bench tests and biocompatibility assessments, not clinical data requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a passive, disposable electromyograph needle, not an AI-powered diagnostic tool that would typically undergo such a study to evaluate human reader improvement with AI assistance.

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

No, this is not an AI/ML algorithm. It's a physical medical device.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" was established by compliance with the ISO 10993-1 standard and comparison of direct patient contact materials. For performance testing, the "ground truth" was established by compliance with internal requirements and the ISO 7864 standard for sterile hypodermic needles.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

Not applicable. There is no training set.

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The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

The Nicolet Wireless Amplifiers are used in a wide variety of EEG applications including: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep and ICU. The proposed amplifiers are small portable devices that can run on main electrical A/C power or use a portable battery pack. The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier. These units can acquire from up to 32 or 64 channels, they can be grouped or "cascaded" together for more channels. The amplifiers are capable of acquiring a variety of electrophysiological signals at variable sampling frequencies. These signals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, and other signals standard to neurological and sleep testing. The amplifiers have wireless capability and a battery pack for mobile data acquisition. Wireless access points collect the wireless data transmissions. The amplifiers can be connected to the Ethernet by a cable and also to AC power. The amplifiers are IP addressable and can be connected directly to a network device. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.

The provided document [K103140](https://510k.innolitics.com/search/K103140) describes the Nicolet Wireless EEG Amplifier, an electroencephalograph device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Clinical testing was not performed with this device." Instead, the submission relies on non-clinical performance tests conforming to various international standards. Therefore, an explicit "test set" in the context of clinical data (like patient cases) is not applicable here. The "sample" for these non-clinical tests would refer to the physical device units tested, but this detail is not provided.

• Data Provenance: The tests are non-clinical, meaning they are bench tests conducted in a laboratory setting against engineering standards. The country of origin for the data is not specified beyond the company's address in Middleton, WI, USA, implying testing was likely conducted in the USA or by facilities adhering to these international standards.

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

Since no clinical testing was performed and the evaluation was based on non-clinical performance data against established standards, the concept of "ground truth" derived from expert consensus on medical cases does not directly apply in this submission. The "ground truth" for these tests is defined by the requirements of the referenced international standards (e.g., IEC 60601-1, ISO 14971, etc.). Compliance with these standards is determined by trained engineers and technicians, not medical experts.

4. Adjudication Method for the Test Set

As the evaluation was based on non-clinical performance against engineering standards, an "adjudication method" involving multiple expert interpretations of medical data is not relevant. The pass/fail criteria for each test are typically defined by the specific standard, and results are objectively measured.

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

No. The document explicitly states: "Clinical testing was not performed with this device." Therefore, an MRMC comparative effectiveness study was not conducted.

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

This device is an Electroencephalograph (EEG) amplifier, which is hardware for acquiring physiological signals. It does not contain an "algorithm only" component in the sense of AI software. The performance tests are for the physical device's electrical, safety, and functional characteristics. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on engineering standards and normative references. The device's performance was measured against the specified requirements within standards such as:

• IEC 60601-1 (Basic safety)
• IEC 60601-4 (Programmable Electrical Medical Systems)
• IEC 60601-6 (Usability)
• IEC 60601-1-2 (EMC Compatibility)
• IEC 60601-1-1 (Collateral Safety)
• IEC 60601-2-26 (Electroencephalographs)
• ISO 14971 (Risk Management)
• ISO 10993-1 (Biocompatibility)
• FCC Part 15C, FCC OET Bulletin 65, Supplement C (FCC Specific Absorption Ratio)
• UN/DOT 38.3 (Battery safety)

These standards define the acceptable performance parameters.

8. The Sample Size for the Training Set

No training set is mentioned as this is not an AI/machine learning device. The "training" for such a device involves engineering design, development, and adherence to established specifications.

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

Not applicable, as no training set was used for an AI/machine learning algorithm. The "ground truth" for the device's design and manufacturing is established by the detailed requirements of the relevant safety and performance standards.

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