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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.

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. This submission is a 510(k) for a physiological signal amplifier, comparing its technical specifications to a predicate device. It does not involve a "test set" of patient data in the way an AI/software device would. The evaluation is based on engineering specifications and adherence to safety standards.

2. 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. No ground truth in the context of expert medical interpretation for patient data is established or required for this type of device submission. The device's performance is measured against technical specifications and regulatory standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. See above.

4. 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:

   • No. This is not an AI/software device designed to assist human readers, so an MRMC study is not relevant or included.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. The Nic36 Amplifier is a hardware device for signal acquisition and amplification; it is not an algorithm, and thus standalone performance for an algorithm is not relevant.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not Applicable. For this submission, the "ground truth" or standard for comparison is the technical specifications and regulatory compliance of the predicate device (Mizar Amplifier K003154) and relevant international safety standards (IEC 601-1, IEC 601-1-2, IEC 601-2-26, IEC 601-1-4). The device's own performance is measured against these technical benchmarks, not clinical outcomes or expert consensus on patient data.

7. The sample size for the training set:

   • Not Applicable. This is a hardware device, not a machine learning algorithm, so there is no training set.

8. How the ground truth for the training set was established:

   • Not Applicable. This is a hardware device, not a machine learning algorithm, so there is no training set or ground truth for one.

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