(241 days)
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)
| Characteristic | Implied Acceptance Criterion (e.g., matching or exceeding predicate, meeting standard) | CareFusion Nicolet EDX System (this submission) Performance |
|---|---|---|
| I. Safety & Regulatory | ||
| Biocompatibility | Compliance with ISO 10993-1: 2009 | Complies with ISO 10993-1: 2009 |
| Software Level of Concern | Software designed & developed according to robust process, vigorously verified & validated, consistent with FDA guidelines. | MODERATE level of concern software; designed and developed according to robust SDLC; rigorously verified and validated consistent with FDA guidelines. |
| Electrical Safety (IEC) | Compliance with IEC 60601-1: 1988, Am1: 1991, Am2: 1995 | Complies with IEC 60601-1: 1988, Am1: 1991, Am2: 1995 |
| Electrical Safety (UL) | Compliance with UL 60601-1: 2006 | Complies with UL 60601-1: 2006 |
| EMC Testing | Compliance with IEC 60601-1-2: 2001, Am1: 2004 | Complies with IEC 60601-1-2: 2001, Am1: 2004 |
| Performance (Electromyographs & EP) | Compliance with IEC 60601-2-40: 1998 | Complies with IEC 60601-2-40: 1998 |
| II. Technical Specifications (Acquisition) | ||
| Number of channels | Equal to or greater than many predicate devices (e.g., 2-8 of Viking II) | 2 to 8 |
| CMMR | > 105 dB (from predicate Viking II) | > 110 dB |
| Noise | 1000 MΩ (from predicate Viking II) | > 1000 MΩ |
| Low Filter | Comparable to predicate devices (e.g., 0.2 Hz to 5 kHz) | 0.05 Hz to 5 kHz |
| High Filter | Comparable to predicate devices (e.g., 30 Hz to 20 kHz) | 30 Hz to 20 kHz |
| Notch Filter | 50 / 60 selectable (common to all predicates) | 50 / 60 selectable |
| A/D Conversion | 16 bit (from predicate Viking II) | 24 bit |
| Sampling Rate (cumulative) | 100 kHz (from predicate Viking II) | 384 kHz |
| Time Base Range | 0.01 to 5000 ms (common to all comparable predicates) | 0.01 to 5000 ms |
| Number of Time Bases | Multiple (common to all comparable predicates) | Multiple |
| Trigger Mode | Free run, internal, external (common to all comparable predicates) | Free run, internal, external |
| Signal Delay (pre/post) | -3000 to +500 ms (common to all comparable predicates) | -3000 to +500 ms |
| III. Technical Specifications (Electrical Stimulator) | ||
| Type | Constant Current or Constant Voltage (common to comparable predicates) | Constant Current or Constant Voltage |
| Number | 1 or 2 (common to comparable predicates) | 1 or 2 |
| Maximum Output | 100mA or 400V (matching predicate Viking II) | 100mA or 400V |
| Duration | 0.01 to 1 ms (matching predicate Viking II) | 0.01 to 1 ms |
| Mode | Single or Train (common to all predicates) | Single or Train |
| Biphasic | Yes (exceeding predicate Viking II, matching some others) | Yes |
| IV. Technical Specifications (Auditory Stimulator) | ||
| Type | Click, Pip, Burst (common to all comparable predicates) | Click, Pip, Burst |
| Intensity | 0 to 139 dB pSPL (matching predicate Viking II) | 0 to 139 dB pSPL |
| Polarity | Condensation, Rarefaction, Alternating (common to all comparable predicates) | Condensation, Rarefaction, Alternating |
| Tone Frequency | 250 to 8000 Hz (matching predicate Viking II, within range of others) | 250 to 8000 Hz |
| Click Duration | 0.05 to 1 ms (matching predicate Viking II, within range of others) | 0.05 to 1 ms |
| Side | Left, Right, Both (common to all comparable predicates) | Left, Right, Both |
| V. Application Modules | ||
| NCS, EMG, EP, Autonomic Responses, IOM | Availability comparable to or exceeding combined functionalities of predicate devices | Offers all these as described in Indications for Use. |
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.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).