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The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device-HeadaTerm enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort.

The device could adhere to patients forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses.

The provided document is a 510(k) premarket notification for the TENS device-HeadaTerm, indicating it is substantially equivalent to a legally marketed predicate device (Cefaly). This submission focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics, rather than presenting a performance study with acceptance criteria often seen for AI/ML-driven medical devices that require a clinical effectiveness study.

Therefore, many of the requested details, such as acceptance criteria based on clinical performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets in clinical studies, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and details on training sets for an AI/ML model, are not applicable or not provided in this type of 510(k) submission.

This device, a Transcutaneous Electrical Nerve Stimulator (TENS), is cleared based on its equivalence to an existing TENS device for prophylactic treatment of episodic migraine, demonstrated through non-clinical testing (electrical safety, electromagnetic safety, performance of nerve and muscle stimulators, performance for home use, biocompatibility).

Here's an attempt to address the points based on the provided document, highlighting what is available and what is not:

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

The document does not present "acceptance criteria" in terms of clinical performance metrics like sensitivity or specificity, nor does it report device performance against such metrics. Instead, it focuses on demonstrating equivalence to a predicate device through non-clinical testing and comparison of physical and electrical specifications.

The "acceptance criteria" can be inferred as successful completion of the listed non-clinical tests and demonstrating comparable technical specifications to the predicate device.

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

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (bench testing for electrical safety, biocompatibility, etc.) and a comparison of technical specifications to the predicate device, not on a clinical performance test set with patient data.
• Data Provenance: Not applicable for a clinical test set. The non-clinical testing results would originate from the testing laboratories.

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

• Not applicable. There is no clinical test set requiring expert ground truth for diagnosis/classification in this 510(k) submission as it is not an AI/ML diagnostic device. The ground truth for electrical and biocompatibility testing is based on established engineering and safety standards.

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

• Not applicable. There is no clinical test set requiring adjudication in this submission.

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 TENS device, not an AI-assisted diagnostic or treatment planning tool. Therefore, no MRMC study or AI assistance evaluation was conducted or required for this type of submission.

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

• Not applicable. This device is a TENS device, not an AI algorithm.

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

• The "ground truth" for this type of device is based on engineering standards (e.g., IEC standards for electrical safety, performance, and home use) and biocompatibility standards. It's about meeting specified physical, electrical, and material safety parameters, not diagnostic accuracy.

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device (TENS) that does not employ machine learning or AI models, and thus does not have a "training set" in the context of AI/ML development.

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

• Not applicable for the same reason as above (no AI/ML training set). The device is tested against established performance and safety standards, not trained on data with established ground truth.

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