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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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Symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Basic Design Description of submission compares the specifications of the ENDOR 2000 with a legally marketed product, the model 804S III (K893874B) sold by Altoona Medical Supply and manufactured by the manufacturer of the ENDOR 2000. Because the electrical parameters mimic those of the 804S III, it is claimed that the ENDOR 2000 is substantially equivalent to an existing, legally marketed product.

Based on the provided 510K summary, the Endor 2000 TENS Device was not subjected to clinical testing or acceptance criteria. Instead, it relied on a claim of substantial equivalence to a legally marketed predicate device, the model 804S III (K893874B).

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable. No clinical tests or test sets were used.
• Data Provenance: Not applicable.

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 for a test set was established as no clinical tests were performed.

4. Adjudication method for the test set

• Not applicable. No test set or clinical study was conducted.

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 TENS device, not an AI-powered diagnostic tool, and no MRMC study was conducted.

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

• Not applicable. This device is a TENS device, not an algorithm, and no standalone performance study was done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No clinical ground truth was established for the Endor 2000. Its "ground truth" for regulatory purposes was based on its design and electrical parameters mirroring those of the predicate device.

8. The sample size for the training set

• Not applicable. There was no training set, as no machine learning algorithm was involved.

9. How the ground truth for the training set was established

• Not applicable. There was no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proved the Endor 2000 met its "acceptance criteria" (which were implicit in the substantial equivalence argument) was a comparison of the device's electrical parameters and design specifications with those of a legally marketed predicate device, the model 804S III.

The 510K summary explicitly states: "Non clinical data submitted (Basic Design Description of submission) compares the specifications of the ENDOR 2000 with a legally marketed product, the model 804S III (K893874B)... Because the electrical parameters mimic those of the 804S III, it is claimed that the ENDOR 2000 is substantially equivalent to an existing, legally marketed product."

The conclusion further reinforces this: "It is concluded that because the ENDOR 2000 was designed like the 804S III keeping all electrical parameters alike (and even using similar circuitry), that it is substantially equivalent to the 804S III."

No clinical trials, human subject testing, or performance data were submitted or required for this 510(k) clearance, as explicitly stated: "Clinical tests: No clinical tests were performed."

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