(84 days)
The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.
The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.
EMG Family devices (NEXT Station and NEXT Station Advanced) are capable of detecting electrical signals produced by the central and peripheral nervous systems and by striated muscles. In connection with a PC, where the Galileo NT Line software is installed, they allow to perform both spontaneous and evoked electromyographic activity easily and in all their phases. Their fields of application are Electromyography (EMG) and Evoked Potentials (EP).
EB Neuro EMG Family devices include all the elements necessary for the acquisition of neurographic signals, for their analog-digital conversion and pre-processing, for audio monitoring, for the delivery of electrical, acoustic and visual stimulation. The functions of user interface, presentation, post-processing, storage, signals archiving and printing and data extracted from them are managed by a PC installed with the Galileo NT Line software.
Two versions are available depending on the support where the Medical Device is placed:
- “Mobile” is a mobile device placed on a cart, powered at 115V by Isolation Transformer and connected with a PC with Galileo NT Line medical device software running on the PC.
- “Portable” is a portable device placed on a desk, powered at 115V by medical power supply and connected with a PC with Galileo NT Line medical device software running on a Laptop PC.
This FDA 510(k) summary (K242832) for the EB Neuro S.p.A. NExT Station and NExT Station Advanced devices focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against predefined acceptance criteria for a new clinical claim. The summary explicitly states that:
"The subject devices are essentially a bundled together package of our own previously cleared predicate devices. The first predicate device Nemus 2 is an EMG amplifier hardware and the second predicate device Galileo NT is an EMG analysis software. They were previously 510(k) cleared on their own and are now being bundled together as a full EMG system.
No new features are added to the subject devices compared to the predicate devices. The subject devices essentially have the same design as the predicate devices."
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication, and MRMC studies is not applicable in the context of this 510(k) submission. The submission's primary purpose is to show that the new combined device performs substantially similarly to its already-cleared components and does not introduce new safety or effectiveness concerns.
However, I can extract information related to the device's technical specifications and the testing performed to ensure it meets general safety and performance standards relevant to medical devices:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a bundled device with "no new features" in terms of clinical performance, there isn't a table of clinical acceptance criteria vs. device performance in the traditional sense of a de novo device. Instead, the acceptance criteria are met by demonstrating compliance with recognized standards and equivalence in technical specifications to the predicate devices. The performance is assessed against these standards and predicate device specifications.
| Feature/Standard | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (NExT Station / NExT Station Advanced) | Comments on Performance |
|---|---|---|---|
| Intended Use | Same as combined predicate devices. | "The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles. The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis." | Declared identical or combined from predicates. |
| Intended Usage Site | Hospitals, laboratory, institutions, or other test environments. Intensive Care Unit or Operating Room for continuous recording. | Hospital environments. | Same as predicate. |
| Intended User | Qualified medical practitioners (Neurology physicians, Neurophysiopathology technicians under physician's supervision, other physicians, nursing staff). | Neurology physicians, Neurophysiopathology technicians under physician's supervision, other physicians such as anesthesiologists, neonatologists and nursing staff of intensive care unit. | Same as predicate. |
| System Configuration | Signal acquisition device connected to a PC with Galileo NT software, placed on trolley or desk. | Signal acquisition device connected to a PC with Galileo NT software running on the PC. It can be placed on a trolley (mobile version) or on a desk (portable version). | Similar; combined from predicates. |
| Power Supply | 115 V medical power supply. | 115 V medical power supply. | Same as predicate. |
| Computer | Desktop PC or Laptop PC. | Desktop PC, Laptop PC. | Same as predicate. |
| Operating System | Windows. | Windows. | Same as predicate. |
| Software | Resident and runtime downloadable. | Resident and runtime downloadable. | Same as predicate. |
| Communication Protocol | TCP/IP link on "wired LAN" ETHERNET/IEEE 802.3. | TCP/IP link on "wired LAN" ETHERNET/IEEE 802.3. | Same as predicate. |
| Signal Acquisition | Analog to digital conversion at variable sampling rate. | Analog to digital conversion at variable sampling rate. | Same as predicate. |
| Trigger Input | TTL LEVEL – negative slope. | TTL LEVEL – negative slope. | Same as predicate. |
| Trigger Output | TTL signal - active high, 20us duration. | TTL signal - active high, 20us duration. | Same as predicate. |
| Patient Circuitry Isolation | Patient isolation BF type. | Patient isolation BF type. | Same as predicate. |
| Measurement Principle | Acquisition of physiological signal elaborated on Host PC software. | Acquisition of the physiological signal that is subsequently elaborated on the software on Host PC. | Same as predicate. |
| Number of Channels (EMG) | Nemus 2: 2 EMG channels | NExT Station: 4 EMG channels | |
| NExT Station Advanced: 4 EMG channels | Increased. "Difference in the number and type of channels address different market needs and preferences, they do not raise any additional questions of safety or effectiveness." | ||
| Number of Channels (EP) | Nemus 2: 20 EP channels | NExT Station: N/A | |
| NExT Station Advanced: 8 EP channels | Different. "Difference in the number and type of channels address different market needs and preferences, they do not raise any additional questions of safety or effectiveness." | ||
| CMRR | > 100 dB (Predicate Nemus 2) | > 110 dB | Improved (higher is better). Meets or exceeds predicate. |
| Noise | 100 MΩ. | > 100 MΩ. | Same as predicate. |
| Low Pass Filter | 20 KHz (Predicate Nemus 2) | 10 KHz | Lower. "Subject devices remove high frequency components for effective removal of noise and artifacts." This is presented as an enhancement. |
| High Pass Filter | Selectable 0.1 Hz or 10 Hz (Predicate Nemus 2) | 0.1 Hz | Different options. "Subject devices remove high frequency components for effective removal of noise and artifacts." |
| A/D Conversion (EMG) | 24 bit (Predicate Nemus 2) | 24 bit | Same as predicate. |
| A/D Conversion (EP) | 16 bit (Predicate Nemus 2) | 24 bit (NExT Station Advanced) | Improved (higher resolution). |
| Sampling Rate | 32768 Hz (EMG ch); 16384 Hz (EP ch) (Predicate Nemus 2) | Adjustable: 2048, 4096, 8192, 16384, 32768, 65536 Hz | Higher maximum sampling frequency. "Subject devices have maximum sampling frequency higher than predicate devices, ensuring a higher fidelity digitization." |
| Electrical Stimulation - No. of Outputs | 1 (Predicate Nemus 2) | 2 | Increased. "Additional stimulation output on the subject devices has no impact on safety or effectiveness." |
| Electrical, Mechanical and Thermal Safety | Compliance with ANSI AAMI 60601-1. | Complies with ANSI AAMI 60601-1. | Compliance demonstrated. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2. | Complies with IEC 60601-1-2. | Compliance demonstrated. |
| EMG and EP Requirements | Compliance with IEC 60601-2-40. | Complies with IEC 60601-2-40. | Compliance demonstrated. |
| Light Hazard Protection | Compliance with EN ISO 15004-2. | Complies with EN ISO 15004-2. | Compliance demonstrated for new visual stimulators. |
| Photobiological Safety of Lamps and Lamp Systems | Compliance with EN 62471. | Complies with EN 62471. | Compliance demonstrated for new visual stimulators. |
| Medical Device Software | Compliance with IEC 62304. | Complies with IEC 62304. | Compliance demonstrated. |
| Medical Device Risk Management | Compliance with ISO 14971. | Complies with ISO 14971. | Compliance demonstrated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not discuss a clinical test set or data provenance in the context of diagnostic performance. The "testing" mentioned refers to engineering verification and validation (V&V) to ensure compliance with standards and the predicate device's technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as there was no clinical study comparing device findings to a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 physiological signal amplifier and software system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a measurement and display system for physiological signals, intended for use by qualified medical professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance is assessed against technical standards and the specifications of predicate devices, not against a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device requiring a training set for algorithm development.
9. How the ground truth for the training set was established
Not applicable.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).