(30 days)
The 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 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 Nicolet EDX 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 Nicolet EDX 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 Nicolet EDX with Natus Elite Software is intended to be used by a qualified healthcare provider.
The Nicolet EDX 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), Electromyoaraphy (EMG), Evoked Potentials (EP), and Autonomic Responses. Nicolet EDX system provides a variety of tests spanning the various modalities.
The Nicolet EDX system consists of the following major components:
- Base unit
- Amplifier (2- or 8-channel)
- Control panels
- Computer- laptop or desktop (with display, keyboard and mouse)
- Display Monitor (for desktop system)
- Application Software (Natus Elite)
The Nicolet EDX optional accessories/ components consist of the following:
- Audio stimulators (Headphones or other auditory transducers)
- Visual stimulators (Natus Visual Stimulator, LED goggles or stimulus monitor)
- Electrical stimulators (RS10 comfort probe, WR50 comfort probe plus)
- Cart and associated accessories (such as arms, mounts and isolation transformer
- Miscellaneous options and accessories such as Patient Response button. Single/Triple footswitch, Tendon (Reflex) hammer, Natus photic stimulator, temperature probe, ultrasound device, bone conductor, printer, etc.
The electrodiagnostics system is powered by a connection to mains.
The entire user interface of Nicolet EDX 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 Nicolet EDX 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.
This FDA 510(k) summary for the Nicolet EDX device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study design.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the device's clinical performance with quantitative metrics. Instead, it compares the technological characteristics of the Nicolet EDX to predicate devices, implying that meeting or being substantially equivalent to these characteristics demonstrates acceptable performance.
Here's a table summarizing the technological characteristics described as identical or similar to predicate devices, which serve as an implicit benchmark for acceptance:
| Characteristic | Nicolet EDX (This Submission) | Primary Predicate (K120979) | Reference Predicate (K243495) | Discussion of differences (from document) |
|---|---|---|---|---|
| 1. General | ||||
| Product Code | GWF, IKN | GWF | GWF | Identical to predicate. |
| Indications for Use | Unchanged from primary predicate | Same as Nicolet EDX | Same as Nicolet EDX | Identical to predicate. |
| Warnings | Items related to off label use or misuse. | Same | Same | Identical to predicate |
| Contraindications | Not for use in flammable anesthetics or with defibrillation. | Same | Same | Identical to predicate |
| Target Population | Patients with neuromuscular diseases (pediatric and adult) | Same | Same | Identical to predicate |
| Environment of Use | Professional healthcare facility environment. | Same | Same | Identical to predicate |
| 2. General Design | ||||
| General Systems Approach | Computer based equipment with dedicated hardware peripherals/components. | Same | Same | Identical to predicate |
| User Input Device | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Same | Same | Identical to predicate |
| User Output Device | Digital color display and commercial printers. | Same | Same | Identical to predicate |
| Patient Inputs | 1 to 8 channel amplifier, isolated | 1 to 8 channel amplifier, isolated | 1 to 4 channel amplifier, isolated | Identical to primary predicate. Similar to reference predicate. |
| Signal Acquisition | Analog to digital conversion at 48 kHz per sample rate | Same | Same | Identical to primary predicate. |
| Trigger Input (synchronization to external events) | Yes | Yes | Yes | Identical to predicate |
| Trigger Output (synchronization for external devices) | Yes | Yes | Yes | Identical to predicate |
| Footswitch | Yes | Yes | Yes | Identical to predicate |
| Use of standard software platform (Operating System) | Yes, Microsoft Windows | Same | Same | Identical to predicate |
| Customization of protocols | Via storage / retrieval of user defined settings | Same | Same | Identical to predicate |
| Application flexibility / expandability | Via software update | Same | Same | Identical to predicate |
| Patient circuitry isolation | Optic/transformer | Same | Same | Identical to predicate |
| System Components | EDX base console, 2 electrical stimulators, auditory stimulator, trigger I/O, LED goggle interface; Control panel; Amplifier; Computer, monitor, keyboard, mouse, printer | Same | Base console, 1 electrical stimulator, auditory stimulators, trigger I/O, LED goggle interface; Control panel (integrated); Amplifier; Computer; Monitor; Keyboard; Mouse; Printer | Identical to predicate. Similar to the reference predicate. |
| System computer interface | USB | USB | USB | Identical to predicate |
| System power supply | Mains (100 -240VAC) thru an isolation transformer depending on system configuration | Same | Same | Identical to predicate |
| 3. Design - Acquisition | ||||
| Number of channels | 1 to 8 | 1 to 8 | 1 to 4 | Identical to primary predicate. Similar to reference predicate. |
| CMRR | >110 dB, 115 dB typical | >110 dB, 115 dB typical | >120 dB | Identical to primary predicate. Similar to reference predicate. |
| Noise | 1000 MΩ | >1000 MΩ | >1000 MΩ | Identical to primary predicate. |
| Low Filter | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | Identical to primary predicate. |
| High Filter | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 30 Hz to 20 kHz | Identical to predicate. |
| Notch Filter | 50/60 selectable | 50/60 selectable | 50/60 selectable | Identical to primary predicate. |
| A/D conversion | 24 bit | 24 bit | 24 bit | Identical to primary predicate. |
| Sampling rate (cumulative) | 384 kHz | 384 kHz | 192 kHz | Identical to primary predicate. Similar to reference predicate. |
| Trigger mode | Free-run, internal, external | Same | Same | Identical to primary predicate. Similar to reference predicate. |
| Signal delay (pre/post) | -90% to +90% of sweep, depending on time base | Same | Same | Identical to primary predicate. |
| Impedance meter | 500Ω to 480 kΩ | 500Ω to 480 kΩ | 1kΩ to 1,000 kΩ | Identical to primary predicate. Similar to reference predicate. |
| 4. Design - Stimulators | ||||
| 4.1 Electrical Stimulator | ||||
| Type | Constant Current or Constant Voltage | Same | Constant Current | Identical to primary predicate. Similar to reference predicate. |
| Number | 1 or 2 | 1 or 2 | 1 | Identical to primary predicate. Similar to reference predicate. |
| Maximum Output | 100mA or 400V | 100mA or 400V | 100mA | Identical to primary predicate. Similar to reference predicate. |
| Duration | 0.01 to 1 ms | 0.01 to 1 ms | 0.01 to 1 ms | Identical to primary predicate. |
| Mode | Single or Train | Single or Train | Single or Train | Identical to primary predicate. |
| Biphasic | Yes | Yes | Yes | Identical to primary predicate. |
| 4.2 Auditory Stimulator | ||||
| Type | Click, Pip, Burst | Same | Same | Identical to primary predicate. |
| Intensity | 0 to 139 dB pSPL | Same | Same | Identical to primary predicate. |
| Polarity | Condensation, Rarefaction, Alternating | Same | Same | Identical to primary predicate. |
| Tone Frequency | 125 to 8000 Hz | Same | Same | Identical to primary predicate. |
| Click Duration | 0.05 to 1 ms | Same | Same | Identical to primary predicate. |
| Side | Left, Right, Both | Same | Same | Identical to primary predicate. |
| Transducers | Ear Phones, Inserts, Bone Vibrator | Same | Same | Identical to predicate. |
| 4.3 Visual Stimulator | ||||
| LED Goggles | Yes | Yes | Yes | Identical to predicate |
| 5. EMG Application Modules | (All "Yes") | (All "Yes") | (All "Yes") | Identical to predicate |
| 6. Evoked Potential Application Modules | (All "Yes") | (All "Yes") | (All "Yes") | Identical to primary predicate |
| 7. Other Application Modules | (All "Yes") | (All "Yes") | (All "Yes") | Identical to primary predicate |
| 8. Additional Features | ||||
| Automatic Report Narrative Generation | Yes | Yes | Yes | Identical to primary predicate |
| Electrical Stimulus Automation | Yes | Yes | Yes | Identical to primary predicate |
| 9. Image Display and Control Interface | ||||
| Display and control of noninvasive third party imaging modality (e.g., Ultrasound) | Yes, Integrated (concurrent) ultrasound display and control using Sonoscanner Ultrasound System (K232285) with Natus Elite software. | No, Supports ultrasound by supplying a third-party device which operates in a nonintegrated mode. Using the Sonoscanner Ultrasound System (K232285) | Yes, Integrated (concurrent) ultrasound display and control using Sonoscanner Ultrasound System (K232285) with Natus Elite software. | Identical to reference predicate. |
The study proving the device meets the acceptance criteria is detailed by the statement: "Verification and validation activities were conducted to establish the performance and safety characteristics of the Nicolet EDX. The results of these activities demonstrate that the Nicolet EDX is safe, effective, and performance is substantially equivalent to the predicate devices."
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 510(k) summary focuses on "substantial equivalence" based on technological characteristics and general verification/validation, rather than a clinical study with a specific test set, patient data, and provenance.
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 as a detailed clinical study with ground truth established by experts is not described in this summary. The device is for electrophysiological information acquisition and analysis, where "ground truth" often refers to the actual physiological signals or clinical diagnoses, which would typically be assessed by qualified healthcare providers using established medical guidelines.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as a formal clinical study with adjudication of a test set is not detailed.
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
An MRMC study is not mentioned in this summary. The device description explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user." It is a diagnostic aid for acquiring and analyzing physiological information, not an AI-driven interpretive tool that would typically undergo MRMC studies to assess human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study is not mentioned. The device is an electrodiagnostic system with software, but the summary does not present it as an autonomous AI system requiring standalone performance evaluation in the classification sense. Rather, it emphasizes its role as a tool for a "qualified healthcare provider."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since a specific clinical study with a detailed test set is not described, the type of ground truth used is not specified. For a device like this, the "ground truth" for performance validation would likely involve:
- Technical Benchmarking: Verification that the electrical signals acquired and processed meet specified technical parameters by comparing them to known or simulated physiological signals, or against established high-fidelity measurement systems.
- Clinical Utility Confirmation: Ensuring that the output provides information that is consistent with expected physiological responses and is interpretable by healthcare professionals for supporting diagnosis.
8. The sample size for the training set
This information is not provided. This summary does not indicate that the device uses machine learning or AI models that require a "training set" in the conventional sense. The "Natus Elite Software" is application software for data acquisition, display, and analysis, not necessarily a predictive AI model requiring a distinct training dataset.
9. How the ground truth for the training set was established
As no training set is mentioned, the method for establishing its ground truth is not applicable/provided.
§ 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).