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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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THE ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) in patients 18 years of age or older

The ELEXIR device 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 verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.

The provided text does not contain specific acceptance criteria or performance data for the ELEXIR device itself. Instead, it states that the device's safety and effectiveness are supported by non-clinical (biocompatibility, electrical safety, performance, usability, software) tests and a clinical evaluation report based on data from the predicate device, CEFALY® Dual. The document claims that the ELEXIR device is "not applied with clause b.6) of 21CFR882.5981," which likely refers to a requirement for clinical performance data for devices to treat headache. However, it then states that a clinical evaluation report was prepared using collected clinical data of the predicate device, concluding that the subject device is safe and effective.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions 2, 3, 4, 5, 6, 7, 8, and 9 for the subject device (ELEXIR). The document explicitly mentions that clinical performance data for the subject device are not available and that its safety and effectiveness are inferred from the predicate device's data.

Here's a summary of what can be extracted:

• Acceptance Criteria for Non-Clinical Tests: The acceptance criteria for the non-clinical tests are implicitly the successful fulfillment of the listed international and FDA guidance standards.
• Study Proving Device Meets Acceptance Criteria (Non-Clinical): Various non-clinical tests were performed.

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

The document does not provide specific numerical acceptance criteria or performance results for the ELEXIR device in a table format. It states that non-clinical tests were performed in accordance with various standards, implying that meeting these standards constitutes the acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided for ELEXIR. For the clinical evaluation, data was collected from the predicate device. No details on its sample size or provenance are given for the predicate device's clinical data, other than it was "collected clinical data."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no direct clinical study data for the subject device (ELEXIR) is presented. The clinical evaluation relies on data from the predicate device.

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

Not applicable, as no direct clinical study data for the subject device (ELEXIR) is presented.

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

Not applicable. This device is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a transcutaneous electrical nerve stimulator.

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

For the clinical evaluation, the safety and effectiveness for headache treatment were established using "collected clinical data" of the predicate device. The specific type of "ground truth" (e.g., patient-reported outcomes, physician diagnosis, etc.) for the predicate device's data is not detailed in this document.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set. If referring to the predicate device's clinical data used for evaluation, no sample size is provided.

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

Not applicable, as this is not an AI/ML device. If referring to the predicate device's clinical data, the method for establishing ground truth is not specified.

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