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This TENS device is indicated for the 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.

The device is used to transmit electrical pulses through the skin to the underlying peripheral nerves to help in the blockage of the pain signal traveling to the brain.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance:

The document states that the 1818 TENS Unit is substantially equivalent to the Diamond Medical TX-3 TENS Unit (K#883188). This means the acceptance criteria are implicitly that the new device performs at least as well and has the same technological characteristics and intended use as the predicate device, without raising new questions of safety or effectiveness.

Detailed Study Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document explicitly states "Not Applicable" for "Discussion of Clinical Tests Performed." This suggests no specific human clinical test set was used for the 1818 TENS Unit itself to establish its unique performance against a benchmark through a formal clinical trial with a defined sample size. Instead, its equivalence to a predicate device, which likely had its own supporting data, was the primary mechanism for clearance.
   • The "clinical testing supplied" mentioned in the conclusions is likely referring to the information available for the predicate device, or very limited (non-formal study) observational data rather than a dedicated clinical trial for the new device.
   • Therefore, information on sample size, country of origin, or retrospective/prospective nature of a dedicated test set for the 1818 TENS Unit is not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • As no formal clinical test set or study is described for the 1818 TENS Unit itself, this information is not applicable/not provided.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • As no formal clinical test set or study is described, this information is not applicable/not provided.

4. 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:

   • The device is a TENS unit, which is an electrical stimulation device for pain relief, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

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

   • The device is a physical TENS unit, not an algorithm. Therefore, an algorithm-only standalone performance study is not applicable.

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

   • For the non-clinical tests, the ground truth was likely established by adherence to established industry standards (AAMI/ANSI NS-4, IEC 60601-1, IEC 60601-1-2).
   • For the "clinical testing supplied," if any, it would likely refer to pain relief outcomes associated with the predicate device, but no specific outcome data or methodology for ground truth establishment for the 1818 TENS Unit is provided.

7. The sample size for the training set:

   • As this is not an AI/machine learning device, there is no training set in the conventional sense. The "training" for the device's design would come from engineering principles and compliance with standards.

8. How the ground truth for the training set was established:

   • As there is no training set for this type of device, this is not applicable.

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