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The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

The Nicolet Wireless Amplifiers are used in a wide variety of EEG applications including: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep and ICU. The proposed amplifiers are small portable devices that can run on main electrical A/C power or use a portable battery pack. The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier. These units can acquire from up to 32 or 64 channels, they can be grouped or "cascaded" together for more channels. The amplifiers are capable of acquiring a variety of electrophysiological signals at variable sampling frequencies. These signals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, and other signals standard to neurological and sleep testing. The amplifiers have wireless capability and a battery pack for mobile data acquisition. Wireless access points collect the wireless data transmissions. The amplifiers can be connected to the Ethernet by a cable and also to AC power. The amplifiers are IP addressable and can be connected directly to a network device. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.

The provided document [K103140](https://510k.innolitics.com/search/K103140) describes the Nicolet Wireless EEG Amplifier, an electroencephalograph device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Clinical testing was not performed with this device." Instead, the submission relies on non-clinical performance tests conforming to various international standards. Therefore, an explicit "test set" in the context of clinical data (like patient cases) is not applicable here. The "sample" for these non-clinical tests would refer to the physical device units tested, but this detail is not provided.

• Data Provenance: The tests are non-clinical, meaning they are bench tests conducted in a laboratory setting against engineering standards. The country of origin for the data is not specified beyond the company's address in Middleton, WI, USA, implying testing was likely conducted in the USA or by facilities adhering to these international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical testing was performed and the evaluation was based on non-clinical performance data against established standards, the concept of "ground truth" derived from expert consensus on medical cases does not directly apply in this submission. The "ground truth" for these tests is defined by the requirements of the referenced international standards (e.g., IEC 60601-1, ISO 14971, etc.). Compliance with these standards is determined by trained engineers and technicians, not medical experts.

4. Adjudication Method for the Test Set

As the evaluation was based on non-clinical performance against engineering standards, an "adjudication method" involving multiple expert interpretations of medical data is not relevant. The pass/fail criteria for each test are typically defined by the specific standard, and results are objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical testing was not performed with this device." Therefore, an MRMC comparative effectiveness study was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This device is an Electroencephalograph (EEG) amplifier, which is hardware for acquiring physiological signals. It does not contain an "algorithm only" component in the sense of AI software. The performance tests are for the physical device's electrical, safety, and functional characteristics. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on engineering standards and normative references. The device's performance was measured against the specified requirements within standards such as:

• IEC 60601-1 (Basic safety)
• IEC 60601-4 (Programmable Electrical Medical Systems)
• IEC 60601-6 (Usability)
• IEC 60601-1-2 (EMC Compatibility)
• IEC 60601-1-1 (Collateral Safety)
• IEC 60601-2-26 (Electroencephalographs)
• ISO 14971 (Risk Management)
• ISO 10993-1 (Biocompatibility)
• FCC Part 15C, FCC OET Bulletin 65, Supplement C (FCC Specific Absorption Ratio)
• UN/DOT 38.3 (Battery safety)

These standards define the acceptable performance parameters.

8. The Sample Size for the Training Set

No training set is mentioned as this is not an AI/machine learning device. The "training" for such a device involves engineering design, development, and adherence to established specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used for an AI/machine learning algorithm. The "ground truth" for the device's design and manufacturing is established by the detailed requirements of the relevant safety and performance standards.

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