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Indicated for the symptomatic relief and management of chronic (long term) intractable pain ind/or as an adjunct treatment in the management of post-surgical and post-traumatic acute pain.

The DuoMed™ Series 500 is a non-invasive nerve stimulation therapy device, indicated for use in treatment of symptomatic relief of and management of long-term intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. It has an adjustable pulse amplitude, pulse rate, and pulse width, with an automatic modulation mode for the pulse width. It can be used in "normal" modes,"burst" mode or in "modulation" mode following the directions of the prescribing physician. Like the Graham-Field (and several other) devices it operates with a 9 V alkaline or nickel-cadmium rechargeable battery.

The provided text describes a 510(k) premarket notification for the DuoMed™ Series 500 TENS device. However, it does not contain any information regarding acceptance criteria, device performance studies, or details about test set samples, expert ground truth, or adjudication methods.

The document specifically states: "Performance standards: No mandatory standards applicable." This implies that the device's substantial equivalence was based on its similarity to previously cleared predicate devices (Graham-Field TENS Plus K924876 and Yoram device K002297), rather than meeting specific performance metrics from an independent study.

Therefore, I cannot provide the requested information from the given input.

Here's a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available. The submission focuses on substantial equivalence to predicate devices, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not available. No study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No study is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available. No study is detailed.
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 TENS 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. This is a TENS device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available. No study is detailed.
8. The sample size for the training set: Not applicable. This is a TENS device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable. This is a TENS device, not a machine learning model.

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