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As a TENS unit, the Body Clock Duo is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:

• Relaxation of muscle spasms; ●
• Prevention or retardation of disuse atrophy; ●
• Increasing local blood circulation; ●
• Muscle re-education; ●
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
• Maintaining or increasing range of motion. ●

The Body Clock Duo has two facilities, enabling it to function as both a TENS unit and as a Powered Muscle Stimulator. As a TENS unit, the Body Clock Duo transmits electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain. As a Powered Muscle Stimulator, the Body Clock Duo can be used to relax muscle spasms, prevent or retard disuse atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

The Body Clock Duo is a Transcutaneous Electric Nerve Stimulator (TENS) and Powered Muscle Stimulator. The submission states that no clinical testing was performed to establish acceptance criteria or demonstrate device performance because "there are no new or innovative aspects that have been introduced." Instead, the device's substantial equivalence to predicate devices (FUJI TENS 804SIII (K893874) and Altoona EMS 400 (K913272)) and compliance with relevant non-clinical standards are relied upon.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

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The Body Clock EMS 400 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:

• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy;
• Increasing local blood circulation;
• Muscle re-education;
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
• Maintaining or increasing range of motion.

The EMS 400 a dual channel EMS (Powered Muscle Stimulator) unit. It is identical to the Altoona EMS 400 (K913272). It has two intensity (amplitude) dials for each channel, placed on the front of the unit. Directly below the left-hand-side intensity dial is a pulse rate dial, which sets the pulse rate for both channels. Below the right-hand dial is a timer dial, which controls the time of each cycle when cycle or reciprocal mode is used. If the dial is set to 0, the unit provides a constant mode.

The provided text describes a 510(k) summary for the Body Clock EMS 400, a powered muscle stimulator. It states that clinical testing was "Not Applicable as there are no new or innovative aspects that have been introduced." The device's substantial equivalence is based on its similarity to a predicate device (EMS 400, K913272) and adherence to non-clinical standards (CE marking, ISO, EN standards).

Therefore, the specific information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert involvement, adjudication, MRMC, standalone performance, training set) is not available in the provided document. The submission relies on the concept of substantial equivalence rather than a new clinical study demonstrating performance against specific acceptance criteria.

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