(29 days)
The SD20 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 Sandman SD20 Amplifer is a fully programmable system which provides a total of 22 analog input channels cach of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Sandman SD20 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transducer on the surface of the human body. It captures the data, converts it into a digital form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Sandman SD20 Amplifier contains a Pulse Oximeter module. The data measured from this module is passed to the host computer together with the other channels' data. The MP100 Pulse Oximeter module, developed by Nellcor Puritan Bennett, is substantially equivalent to Nellcor Puritan Bennett's MP400 Pulse Oximeter module cleared with EB Neuro's Mizar Amplifier via K003154.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Sandman SD20 Amplifier system consists of four interconnected units: the headbox, the amplifier box, the PC interface (BE Net/Sandman eLink) and the AC/DC adapter.
The provided text is a 510(k) premarket notification for the Sandman SD20 Amplifier. This document focuses on demonstrating substantial equivalence to a predicate device (EB Neuro Mizar Amplifier K003154) rather than presenting a standalone study with acceptance criteria and performance data in the traditional sense of a clinical trial or performance study for a diagnostic algorithm.
Therefore, the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is largely not present in this type of regulatory submission.
The acceptance criteria in this context are implicitly that the new device (Sandman SD20 Amplifier) performs at least as well as, or is substantially equivalent to, the predicate device (EB Neuro Mizar Amplifier K003154) based on technological characteristics and intended use.
Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state "acceptance criteria" as performance metrics with thresholds like sensitivity, specificity, accuracy, or a specific signal quality benchmark. Instead, it presents a comparison of technological characteristics between the proposed device and its predicate, implying that performance is acceptable if these characteristics are substantially equivalent and meet established industry standards for physiological signal amplifiers.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Sandman SD20 Amplifier) |
|---|---|---|
| Intended Use | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations (Same as predicate) | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations |
| 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) |
| CMMR | >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).