(25 days)
The Nic36 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.
The Nic36 Amplifer is a fully programmable system which provides a total of 36 analog input channels each of which can be configured as monopolar or bipolar. The bioelectric signals are amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Nic36 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transdaor on the surface of the human body. It captures the data, converts it into a digital format and transmits it on to a host computer running appropriate software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Nic36 Amplifier does not contain a Pulse Oximeter module.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Nic36 Amplifier system consists of three interconnected units: the amplifier box, the PCMCIA or BE Net interface and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the EB Neuro Nic36 Amplifier:
This 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (EB Neuro Mizar Amplifier K003154) rather than presenting a detailed independent study with specific acceptance criteria as you might find for a novel AI/software device. The information provided is characteristic of a Class II medical device where performance is compared against an already cleared predicate.
Therefore, many of your requested sections related to traditional study design, ground truth, and reader studies are not explicitly present or applicable in the provided text. I will fill in what can be inferred or explicitly stated.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on establishing substantial equivalence to the predicate device, the EB Neuro Mizar Amplifier (K003154). The Nic36 Amplifier's performance is considered acceptable if its technological characteristics and intended use are similar enough to the predicate such that it raises no new questions of safety and effectiveness.
| Item | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Nic36 Amplifier) |
|---|---|---|
| Intended Use | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations |
| EEG/Polygraphic Channel | 32/40 (64/96/128 with expansion boards) | 36 monopolar fixed - (no expansion boards) |
| DC Channel | 32/40 | 4 |
| A/D Conversion | 16 bit Sigma-Delta A/D effectively transferred to host | 16 bit SAR effectively transferred to host |
| Sampling Rate | User selectable (128, 256, 512...up to 32 KHz/Channel) | User selectable (128, 256, 512...up to 8192 Hz/Channel) |
| CMRR | >100dB | >100dB |
| Noise |
§ 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).