(103 days)
The Nemus 2 System is intended to acquire the bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The Nemus 2 System consists of a physiological signal amplifier, an evoked response auditory stimulator, an evoked response electrical stimulator, and an evoked response photic stimulator. The user needs to assure compatibility of the Nemus 2 System to the other components of the user's own system.
The Nemus 2 System is made up of the Nemus 2 Amplifier/Stimulator, an AC/DC converter to power the amplifier, a "junction box" to connect the system to the Host PC, and (optionally) by a dedicate keyboard and a Flash LED stimulator.
The Nemus 2 System is intended to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The device may use electrical stimulus, sound stimulus, or visual stimulus for use in evoked response analysis.
The Nemus 2 System is an amplifier/stimulator device especially developed to amplify biological signals. The amplifier captures the biological signal from the human body through specialized sensors or electrodes, amplifies the very low electrical signal, and filters it to accomplish an antialiasing in order to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are "passed" to a host computer, which at this point is free to elaborate the data following the logic of the application software running on the host. The Nemus 2 System is not involved in the data management performed by the host.
Here's an analysis of the provided text regarding the Nemus 2 System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K133517) is a 510(k) summary for a medical device. In these summaries, acceptance criteria are typically presented as technical specifications that the new device must meet to demonstrate substantial equivalence to predicate devices. The study proving these criteria are met is usually a series of non-clinical bench tests.
| Acceptance Criteria (Technical Specification) | Reported Device Performance (Nemus 2) |
|---|---|
| Safety Standards Conformity | Conforms to: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-26, IEC 60601-2-40 |
| Saturation | Verified to meet technical specifications |
| Polarization | Verified to meet technical specifications |
| Offset & Gain | Verified to meet technical specifications |
| Noise (EMG Channels) | 100 dB |
| IMRR (Input Mode Rejection Ratio) | >100 dB |
| Input Impedance (EMG) | Same as Nemus 1 (>100 MΩ) |
| Input Impedance (EEG/EP) | Same as BE Plus LTM (Comm. Mode: 3.3 MΩ, Differential: 6.6 MΩ) |
| Number of Channels (EMG) | 2 EMG |
| Number of Channels (EEG/EP) | 20 EEG/EP |
| A/D Conversion (EMG) | 24 bit |
| A/D Conversion (EEG/EP) | 16 bit |
| Sampling Rate (EEG/EP) | 16384 Hz |
| Sampling Rate (EMG) | 32768 Hz |
| Antialiasing Low Pass Filter (EMG) | 20 KHz |
| Antialiasing Low Pass Filter (EEG/EP) | 2 KHz |
| High-pass Filter (EMG) | 1.6s (0.1 Hz) or 16ms (10Hz) |
| High-pass Filter (EEG/EP) | 1.6/160 ms (0.1/1 Hz) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) summary for engineering verification. The "test set" here refers to the device itself and its components undergoing bench testing, not a dataset of patient cases.
- Data Provenance: Not applicable. The "study" described is verification testing against technical specifications, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth as typically defined for medical AI (e.g., expert labels on images) is not relevant for this type of device and study. The "ground truth" for the verification testing is adherence to established engineering specifications and medical device safety standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing involves objective measurements against predefined technical specifications and safety standards, not a subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance
- MRMC Study: No. This device is a physiological signal amplifier and stimulator, not an AI-powered diagnostic tool that would typically undergo MRMC studies to evaluate reader performance.
- Effect Size of Human Readers: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a hardware device for acquiring and stimulating bioelectric signals, not an algorithm. Its performance is evaluated based on its ability to accurately amplify, filter, and stimulate according to its specifications.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Conformity to international electrical and medical device safety standards (e.g., IEC 60601 series).
- Demonstration through verification testing that the device meets its own established technical specifications for parameters such as noise, CMRR, IMRR, input impedance, and channel characteristics.
- Substantial equivalence to predicate devices (Nemus 1 and BE Plus LTM) based on technological characteristics and intended use.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/machine learning device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. There is no training set or associated ground truth in this context.
§ 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).