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The Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Neriviolnfinity is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically. The device is composed of: A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, embedded in an electrodes pad set. The electrodes pad is disposable and replaceable. An electronic circuitry that includes microcontroller with firmware and for wireless connection to Android and iOS mobile platforms, LED indicator, a USB-C charging port, a power button for activating the device and a battery contained in a plastic enclosure. An armband that is wrapped over the device to secure the NerivioInfinity position on the user's arm is included. The device is operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, battery level, and user notifications.

The provided text is a 510(k) summary for the NerivioInfinity device. It details the device, its intended use, and a comparison to a predicate device (Nerivio). However, it does not contain the information requested regarding acceptance criteria, specific performance data (beyond "functioned as expected"), sample sizes for testing, ground truth establishment, or multi-reader multi-case studies.

The summary explicitly states: "No clinical trials were performed with the subject device, given that the therapeutic elements (electrodes, electrical waveform, location on the body, treatment instructions, treatment duration, etc.) are the same as in the predicate device." This means that the device's performance was not evaluated through a new clinical study. Instead, substantial equivalence was claimed based on its similarity to the predicate device, which presumably underwent clinical testing for its original clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document for the NerivioInfinity, nor details about its test set, ground truth establishment, or clinical study design, as these were not conducted for this specific device clearance.

The "Performance Data" section solely describes non-clinical bench tests and usability tests.

Here's what can be extracted based on the provided text, while also noting what cannot be provided:

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

• Cannot be provided for the NerivioInfinity from this document. The document states that "No clinical trials were performed with the subject device." The "Performance Data" section refers to non-clinical bench tests and usability tests, stating that "In all instances, the NerivioInfinity functioned and expected." No specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, or clinical efficacy outcomes like pain reduction percentages) are detailed for the non-clinical tests.

2. Sample sizes used for the test set and the data provenance:

• A "test set" in the context of clinical performance or AI evaluation (as implied by the question) was not used for this device's clearance according to the document.
• For non-clinical bench tests and usability tests: The specific sample sizes are not provided. The document mentions "internal bench tests and external lab testing" and "Human factor (Usability) tests were performed to validate that all critical tasks related to use-errors and knowledge errors were successfully performed by representative intended users." No details on the number of "representative intended users" or the number of units tested are given.
• Data provenance: N/A for clinical data directly from this device's testing. For the non-clinical tests, the provenance is "internal bench tests" and "external lab testing" without further geographical details. The company is based in Netanya, Israel.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. As no clinical "test set" for performance evaluation (in the sense of the original prompt's context, i.e., diagnostic accuracy or clinical efficacy) was used for this device's clearance, there was no need for experts to establish ground truth in that context. Usability tests involved "representative intended users" but not "experts" establishing "ground truth" on medical outcomes.

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

• N/A. No clinical test set.

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:

• N/A. This device is a direct neuromodulation device, not an AI-assisted diagnostic or therapeutic device that would typically involve human "readers" or an MRMC study.

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

• N/A. This device is a standalone therapeutic device, not an algorithm. Its performance is evaluated through its physical and electrical characteristics and clinical outcomes (established by the predicate device's studies).

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

• N/A for the NerivioInfinity's clearance under this 510(k). The basis for clearance is "substantial equivalence" to the predicate device, meaning its safety and effectiveness are inferred from the predicate's established performance. For the predicate device, it would have been clinical outcomes data (e.g., migraine reduction, pain relief).

8. The sample size for the training set:

• N/A. This device does not have a "training set" in the context of machine learning or AI.

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

• N/A. This device does not have a "training set."

Summary of Device Performance (from the document but not necessarily "acceptance criteria"):

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