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The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

TENS device-HeadaTerm 2 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 2 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 patient's 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, the product provides the user with 9 gear options, and the user can control the stimulating intensity by selecting one of gear.

The provided text describes the regulatory clearance of a medical device (TENS device-HeadaTerm 2) and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document primarily focuses on:

• Regulatory Clearance: FDA 510(k) clearance for the TENS device-HeadaTerm 2 (K230782).
• Device Description: What the device is and how it works.
• Indication for Use: Prophylactic treatment of episodic migraine in patients 18 years or older, for Over-The-Counter (OTC) use.
• Predicate Devices: Comparison to TENS device-HeadaTerm (K172450) and Cefaly® Dual (K201895).
• Technological Characteristics Comparison: A table detailing similarities and differences with predicate devices.
• Performance Data (Non-clinical): Lists standards the device was tested against (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) for safety, EMC, and biocompatibility.
• Usability Verification: A brief mention of a usability study.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document confirms the device passed tests according to various standards but does not list specific numerical acceptance criteria (e.g., a minimum sensitivity or specificity) or the resulting performance values for these criteria.
2. Sample size used for the test set and the data provenance: Only a usability study is mentioned with a sample size of 24 participants. No test set for measuring specific performance metrics (like efficacy in migraine treatment) is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a performance test set with ground truth is not described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated. The document explicitly states "Clinical testing is not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical TENS device, not an AI algorithm.
7. The type of ground truth used: Not applicable as no such performance study is described.
8. The sample size for the training set: Not applicable as no AI/machine learning algorithm training is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The only "study" mentioned with concrete numbers is a usability study:

• Sample size: 24 participants.
• Goal: To prove the device is appropriate for OTC use.
• Outcome: All 24 subjects completed specified tasks correctly (equipment wearing, power-off, intensity adjustment, changing, storage). This implicitly serves as an "acceptance criterion" for usability in an OTC setting, and the reported performance (all 24 subjects successful) meets it.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location, likely China. It's a prospective study.
• Ground Truth: Established by observing correct completion of tasks by the participants and assessment by a "study team and the HCP" (Healthcare Professional), implying expert observation and judgment on task completion.

In summary, the provided document is a regulatory clearance letter and a 510(k) summary, not a detailed clinical or performance study report with specific acceptance criteria beyond adherence to recognized medical device standards and a basic usability verification.

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