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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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Migraine TENS Digital Pain Reliever LT1103

• The acute treatment of migraine with or without aura in patients 18 years of age or older.
• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Migraine TENS Digital Pain Reliever LT1103-P

• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area.

The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity.

The Migraine TENS Digital Pain Reliever consists of the following elements:

• Main Device
• Charging Station
• Electrode Pads
• USB cable

This document is a 510(k) summary for the Migraine TENS Digital Pain Reliever. It describes the device and compares it to a predicate device (Cefaly® Dual) to demonstrate substantial equivalence.

Based on the provided text, here's what can be extracted regarding acceptance criteria and the study proving the device meets them:

This device is a TENS unit for migraine relief, not an AI/imaging diagnostic device. Therefore, many of the requested criteria (like ground truth, expert consensus, MRMC studies, effect size of human improvement with AI, standalone AI performance, training set details) are not applicable to this type of medical device submission.

The acceptance criteria here pertain to safety and performance equivalence with a legally marketed predicate device, rather than diagnostic accuracy or human-AI reader performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table in the typical sense for AI/diagnostic devices. Instead, it demonstrates equivalence by comparing the technical specifications of the new device (Migraine TENS Digital Pain Reliever LT1103, LT1103-P) against the predicate device (Cefaly® Dual, K201895).

The "S.E. Discussion" column in the table below effectively serves as the "reported device performance" against the implicitly accepted predicate's performance.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as this is a TENS device, not an AI/imaging device that would use a test set of patient images or data in that context. The "testing" here refers to engineering and safety performance testing.

• Test Set Sample Size: Not applicable.
• Data Provenance: Not applicable. The "data" comes from engineering tests, not patient studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this device. Safety and performance are established through objective engineering tests against international standards and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of "adjudication" in the context of engineering and safety testing for a TENS device in this 510(k) summary.

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 treatment device, not a diagnostic AI device. Human "readers" are not involved in its primary function, nor is AI assistance relevant to its therapeutic mechanism.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its physical and electrical characteristics.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable in the AI/diagnostic sense. The reference standard or "ground truth" for this submission are:

• International safety and performance standards (e.g., ISO 10993-1, IEC 60601 series).
• The established safe and effective performance of the predicate device (K201895 Cefaly® Dual).

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or require a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

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