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The BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.

The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.

The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.

The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results.

The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change.

The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.

The BREVIO device is a hand-held nerve conduction velocity measurement device intended for use in the diagnosis and monitoring of peripheral neuropathies. The 510(k) summary provides limited details on formal acceptance criteria or detailed study results. Based on the provided text, the device's performance was evaluated through bench testing and comparative human testing against a predicate device.

Here's an attempt to organize the information based on your request, with significant limitations due to the brevity of the study description in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the "comparative human testing." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for this human testing. Given the context of a 510(k) submission in the US, it is implied the testing was likely conducted in the US, but this is not explicitly stated. The testing seems to be prospective in nature, given its description as "comparative human testing" conducted to demonstrate correlation.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth in the "comparative human testing." The testing was a comparison between the BREVIO device and a predicate device, implying the predicate device's readings served as a comparative reference.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance. The "comparative human testing" described seems to be a direct comparison of device measurements, not a study of human readers using the device with and without AI assistance. Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance

The device is implicitly standalone in its measurement capability, as it "automatically picks out the latency and amplitude of waveforms." The "comparative human testing" involved comparing the BREVIO device's measurements directly against a predicate device, which inherently implies standalone performance of the BREVIO in generating those measurements. However, no specific "standalone" study, separated from human involvement in interpretation or adjudication of those measurements, is explicitly detailed. The statement that "These automatically chosen values may be manually adjusted by the user" indicates that while the algorithm provides initial values, human-in-the-loop interaction is an expected part of its use.

7. Type of Ground Truth Used

For the "comparative human testing," the "ground truth" was established by the measurements obtained from a legally marketed predicate device. The document states, "Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for latency and amplitude comparison." This implies the predicate device acted as the reference standard.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This suggests that the device's automatic latency and amplitude detection capabilities might have been developed through internal engineering and testing, rather than a formal, disclosed machine learning training paradigm with a specific dataset.

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

Since no training set is mentioned, the method for establishing its ground truth is also not provided.

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