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Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

Mode 2 (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities

Electronic Pulse Stimulator is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes. It has two modes of different pulse frequencies, mode 1 uses Electrical Muscle Stimulation (EMS) technology for muscle training and mode 2 uses Transcutaneous Electrical Nerve Stimulation (TENS) technology to temporary relieve pain. The device includes operating elements of Power ON/OFF button, intensity increase"+" button, and intensity decrease"-" button and Mode selection button, and could be attached and detached to the electrode pad through the snap-on connector.

In additional, according to different simulation-needed bodies, users can choose the four types of electrode pad based on their own situation. Electronic Pulse Stimulator is suitable for the simulation-needed bodies including hips, arms and legs, abdomen, and feet.

The provided document is a 510(k) Premarket Notification summary for an Electronic Pulse Stimulator (Model S3). It does not contain information about acceptance criteria for a study proving the device meets the acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data related to existing safety and electrical standards. The "performance data" section primarily discusses compliance with various IEC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2) and biocompatibility testing (ISO 10993-1). There is no mention of a clinical study with specific acceptance criteria that would involve human subjects, expert readers, or a ground truth process as typically defined for performance evaluation of diagnostic or AI-driven medical devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain this type of information. It is a regulatory submission for a simple TENS/EMS device for pain relief and muscle stimulation, not a complex diagnostic system that would involve the kind of performance study you are asking about (e.g., MRMC studies, expert ground truth adjudication).

To directly answer your numbered points based on the absence of such information in this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document outlines technological characteristics and compliance with electrical safety and biocompatibility standards, not performance metrics from a study with defined acceptance criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The "testing" refers to bench testing against industry standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is described.
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 not an AI-driven or diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm with standalone performance in the sense of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for a performance study is not established or discussed.
8. The sample size for the training set: Not applicable. This device is not described as involving a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for it is described.

The document states that "The electronic pulse stimulator is substantially equivalent to the predicate devices based on intended use, design, specifications and performance." The "performance" here refers to meeting established electrical safety and biocompatibility standards, not a clinical performance validation against a pre-defined ground truth in a study with human subjects.

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