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The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.

The ELEXIR 2.0 is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal nerve bilaterally. It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attack. The ELEXIR 2.0 is indicated for the acute treatment of migraine and the prophylactic treatment of episodic migraine by applying 100 Hz (Acute mode) and 60 Hz (Prevention mode), low-frequency stimulation to the forehead area percutaneously to the trigeminal nerve.

The provided text is a 510(k) summary for the ELEXIR 2.0 (ALLIVE3) device, a transcranial electrical nerve stimulator for headache treatment. The document focuses on demonstrating substantial equivalence to a predicate device (ALLIVE2 (ELEXIR)) rather than presenting a study of the device's clinical performance against specific acceptance criteria.

Therefore, the requested information regarding "acceptance criteria" for device performance, a "study that proves the device meets the acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details" cannot be extracted from this document, as it describes non-clinical testing for safety and electrical performance, and equivalence to a predicate, not clinical efficacy or diagnostic accuracy.

The document lists various non-clinical tests performed, such as:

• Biocompatibility tests: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), and Intracutaneous Reactivity Test (ISO 10993-10:2010).
• Electrical Safety and EMC tests: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015, and IEC 60601-2-10:2012/A1:2016.
• Performance Tests: IEC 60601-2-10:2012/A1:2016, Technical Test (IEC 60601-2-10:2012/A1:2016), Performance Test under wireless communication (Manufacturer's own standards), and Lifetime study (Manufacturer's own standards).
• Usability V&V: IEC 60601-1-6:2010/A1:2013 and IEC 62366-1:2015.
• Software Test: IEC 62304:2006/A1:2015.

These tests are primarily aimed at establishing the safety and fundamental performance characteristics to claim substantial equivalence, rather than demonstrating specific clinical effectiveness against quantified criteria. The document states, "the safety and performance test reports support the safety and effectiveness of the subject device," which is a general conclusion based on these non-clinical evaluations and comparison to the predicate.

Without a clinical study section, the specific details for clinical performance criteria and their evaluation are not available in this 510(k) summary.

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