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The Milieve is indicated for

• 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.

The Milieve device is a transcutaneous electrical nerve stimulator (TENS) developed for the acute treatment of migraine and the prophylactic treatment of episodic migraine. The device is placed on the patient's forehead to stimulate the upper branch of the trigeminal nerve. It is harmless to the human body. The Milieve device is indicated for OTC use.
There are two treatment programs: ACUTE and PREVENT. The ACUTE treatment program is intended for treatment during migraine attack at the onset of a migraine. The PREVENT treatment program is meant for daily preventative treatment.
The Mileve device comprises a plastic external casing and electrical components. It is operated by an internal rechargeable battery.

The provided text is a 510(k) summary for the Milieve (YPS-301BD) device, a transcutaneous electrical nerve stimulator for migraine treatment. The summary demonstrates substantial equivalence to a predicate device (Cefaly Dual).

The document does not describe a study involving an AI/algorithm where acceptance criteria are set for the performance of the AI model itself. Instead, it focuses on demonstrating the Milieve device's substantial equivalence to a predicate device through bench testing and comparison of technical specifications. The acceptance criteria and "device performance" in this context refer to the physical and electrical characteristics of the Milieve device and how they compare to those of the predicate device.

Therefore, many of the requested points from your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of submission, as the Milieve device is a hardware medical device, not an AI/algorithm-based diagnostic or therapeutic system.

However, I can extract and present the relevant information regarding the device's "performance" and how its "acceptance criteria" (understood as equivalency to the predicate) are met based on the provided text.

Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)

The acceptance criteria for the Milieve device are implicitly based on demonstrating substantial equivalence to the predicate device, Cefaly Dual. This is achieved by showing that the technological characteristics and performance parameters are either identical or substantially equivalent, and that any differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided table directly compares the Milieve device to the Cefaly Dual (Predicate Device). The "Comparison" column indicates whether the parameters are "Identical" or "Substantially Equivalent (SE)" with notes explaining the implications of the differences.

Notes on Substantial Equivalence:

• Note 1 (Ramp down Time): "The subject device has a slightly longer ramp down time. This longer ramp time helps with subject comfort. This difference will not raise new questions of efficacy as the therapeutic session times (20 min and 60 min) are identical."
• Note 2 (Dimensions): "The dimension of the subject device is slightly different from the predicate device. This minor difference will however not raise any new safety and effectiveness issues."
• Note 3 (Weight): "The weight of the subject device is slightly more than the predicate device. This minor weight increase has not impacted the ability to hold device and electrode reliably on the forehead in the in-house tests conducted and the human factors validation study. It is therefore expected to not raise any new safety and effectiveness issues."

Regarding the AI/Algorithm-specific questions (which are not applicable to this submission):

• 2. Sample size used for the test set and the data provenance: Not applicable. The study was bench testing of a hardware device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by direct measurement against engineering specifications and comparison to the predicate device.
• 4. Adjudication method for the test set: Not applicable. Performance was assessed via bench testing.
• 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 is a hardware medical device, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a TENS unit, not an algorithm, and its use is intended for direct patient application (OTC).
• 7. The type of ground truth used: For the technical specifications, the ground truth is the performance parameters of the predicate device and established engineering standards. For the human factors validation (mentioned for weight), the ground truth is likely defined by user feedback and ability to use the device as intended.
• 8. The sample size for the training set: Not applicable. No AI model was trained.
• 9. How the ground truth for the training set was established: Not applicable. No AI model was trained.

Summary of the Study Proving Acceptance Criteria:

The study involved bench testing to demonstrate that the Milieve device's performance parameters are "substantially equivalent" to those of the predicate device (Cefaly Dual). Additionally, software verification and validation and risk management were conducted to support this equivalence. A human factors validation study was also mentioned regarding the device's weight, indicating that the slightly increased weight did not negatively impact usability.

The overarching "acceptance criteria" here is the demonstration of substantial equivalence to a legally marketed predicate device, as per 510(k) requirements. The study successfully met these criteria by showing identical or non-concerning, explained differences in all critical parameters.

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