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NicoletOne System V32 Amplifier is a stand alone electroencephalography (EEG) amplifier for the recording of electrical signals from the brain. An optional feature of pulse oximetery (SpO2) is available.

The NicoletOne System V32 Amplifier is a stand alone EEG amplifier embodiment. The V32 Amplifier supports 32 channels of patient input. The EEG electrode interface (headbox) is integral to the amplifier. The NicoletOne System V32 Amplifier provides an electrophysiological amplifier variation for use with the NicoletOne System. An optional external passive headbox, the HB3, is available for use with the V32 Amplifier. An optional Original Equipment Manufacturer (OEM) supplied pulse oximeter can be provided as a signal input from the patient. The optional OEM pulse oximeter feature is supported by a NONIN XPOD pulse oximeter module and NONIN Pure light 8000X Series Pulse Oximeter Sensor. The V32 Amplifier has a system evaluation signal (calibration signal) to verify system signal pathways, electrode impedance display on the amplifier and uses an Ethernet connection to communicate to the NicoletOne System computer. No physiologic alarms are supported by the V32 Amplifier.

This document describes the NicoletOne System V32 Amplifier with Oximetery, an electroencephalograph (EEG) amplifier. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel acceptance criteria.

Therefore, the specific information requested about acceptance criteria, study design for proving device meets criteria, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly provided in this 510(k) summary.

The document details the technical characteristics and intended use of the device, and states that safety and effectiveness were demonstrated through compliance with the VIASYS NeuroCare Design Control process, including software verification and validation, and hardware and system verification to specifications.

Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging where information is not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" in the way one might expect from a clinical trial or algorithm validation study. Instead, it compares the technical specifications of the V32 Amplifier to a predicate U32 Amplifier to demonstrate substantial equivalence.

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

• Not explicitly stated. The document mentions "Hardware and system verification of conformance to specifications." This typically refers to engineering bench testing of the device hardware and software, not clinical testing with patient data or a "test set" in the context of an algorithm.

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 / Not stated. This device is an EEG amplifier; its performance is typically evaluated against engineering specifications and regulatory standards, not against "ground truth" derived from expert interpretation of images or signals in a clinical study. The device provides raw data for human interpretation.

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

• Not applicable / Not stated. As described above, there is no mention of a "test set" in the context of expert review or adjudication.

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

• No. This is not an AI-assisted device. It is a medical device for acquiring physiological signals.

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

• Not applicable for this type of device. The NicoletOne System V32 Amplifier is a hardware device for signal acquisition, not an algorithm that performs interpretations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not stated. The "ground truth" for this device's performance would be the accurate measurement and transmission of electrical signals according to its engineering specifications and relevant industry standards.

8. The sample size for the training set

• Not applicable / Not stated. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable / Not stated. No training set is mentioned for this device.

Study Proving Device Meets Acceptance Criteria:

The document states: "Testing of the NicoletOne System V32 Amplifier with Oximetery was performed in compliance with the VIASYS NeuroCare, Inc. design control process. Testing included: 1. Software verification and validation, 2. Hardware and system verification of conformance to specifications, and 3. Declaration of safety standard compliance prior to commercial distribution."

This "study" (or rather, set of tests) refers to the internal verification and validation activities conducted by the manufacturer, VIASYS NeuroCare, Inc., as part of their design control process to ensure the device met its design specifications and complied with relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, and ISO 9919). This is the standard procedure for demonstrating substantial equivalence for hardware medical devices in a 510(k) submission. No specific details about the methodology, results, or "acceptance criteria" for these internal tests are provided in this summary, as they are typically kept by the manufacturer and are not required to be detailed in the 510(k) summary itself.

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