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The Neurosign Avalanche Motor Nerve Monitor is a 2 or 4 channel nerve monitor for intraoperative use in general surgery, skull-base surgery and ENT. The Neurosign Avalanche Motor Nerve Monitor allows the user to detect motor nerves and to check their integrity by acquiring the compound muscle action potentials at the target muscles. The acquired signals are processed by the monitor and displayed as waveforms on the monitor screen and played back acoustically via the built in audio amplifier and loudspeaker.

The Neurosign Avalanche Motor Nerve Monitor provides additional information to the user, helping the surgeon to locate nerves by using an electrical stimulator. The sound is independent from the waveform display on the monitor's screen.

The displayed waveforms can be printed along with the patient information via the built in thermal array printer, or as a generated report in Word format.

AI/ML Overview

The provided document describes the Neurosign Avalanche Motor Nerve Monitor and establishes its substantial equivalence to a predicate device, the Neurosign 400. However, it does not contain a comprehensive study with acceptance criteria and detailed device performance results in the format requested. The document focuses on comparing the features and intended uses of the new device to the predicate device in a non-clinical setting.

Here's an analysis of the provided text with respect to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, it relies on a comparison of features and intended use to establish substantial equivalence. The "Non-Clinical Tests Undertaken" section (Section 5.4) lists features that were found to be "similar."

Feature	Predicate Device (Neurosign 400)	Subject Device (Neurosign Avalanche)	Reported Similarity/Performance
Intended use	Cranial motor nerve monitoring	Cranial motor nerve monitoring	Similar, Thyroid version restricted to simpler applications
Method of operation	EMG monitor and stimulator	EMG monitor and stimulator	Similar (detects EMG, amplifies, graphical display)
Stimulation frequency	3 or 30Hz	3 or 30Hz	All machines use the same frequencies, pulse width, and rectangular waveform
Method of display	Amplitude triggered response for continuous monitoring, stimulator triggered response	Screen divided into 2 sections (amplitude triggered, stimulator triggered)	Information displayed is the same, but presented differently
Audio	14W rms amplifier	10W rms amplifier	All machines amplify the EMG signal for audible response. Proportional to input.
Signal detection	Needle and Laryngeal electrode	Needle and Laryngeal electrode	The same electrodes and stimulating probes are used
Bandwidth	10Hz - 5kHz ±3dB	8Hz - 8kHz ±3dB	(Not directly stated as similar in the table, but the Subject Device has a broader range compared to the Predicate. This is a technical specification, not performance.)
Signal Gain	477	500	(A technical specification, Subject Device has slightly higher gain.)
Stimulation Range	0.05mA - 5mA	0.05mA - 10mA	(A technical specification, Subject Device has a wider range.)
Software/Screen	C++ proprietary code, 6" electroluminescent display	Windows XP Embedded, 15" color touchscreen	(Differences noted, but no performance impact assessed in the summary.)
Method of Control	Dedicated buttons or software via menus	Touchscreen (all controls via software except power ON/OFF)	(Differences noted, but no performance impact assessed in the summary.)

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that the assessment was conducted in a "non-clinical setting" (Section 5.4). This means there was no patient data, and therefore no "test set" in the traditional sense of a clinical study. The comparison was based on the functional and technical specifications of the devices.

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

Since no clinical study or test set with patient data was involved, there was no need for experts to establish ground truth or interpret results. The comparison was based on engineering and design specifications.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set or clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence, which primarily relies on technological comparison and intended use, not clinical efficacy studies demonstrating improvement for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device is a medical instrument (nerve monitor) used in real-time by a surgeon "with human-in-the-loop," meaning a standalone algorithmic performance isn't applicable in the context of this device. The information it provides is directly interpreted and used by the surgeon.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the manufacturer's own documentation of the technical specifications, design, and intended use of both the predicate device and the new device. There is no external "ground truth" such as pathology, expert consensus, or outcomes data mentioned for this substantial equivalence submission.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense.

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

Not applicable, as there was no training set.

In summary:

This 510(k) submission (K083242) for the Neurosign Avalanche Motor Nerve Monitor relies on a non-clinical comparison of technical specifications and intended use against a previously cleared predicate device (Neurosign 400). It establishes "substantial equivalence" based on these comparisons rather than presenting clinical study data with acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop performance metrics. The document explicitly states that both devices were "assessed in a non-clinical setting and were determined to be similar."

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