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The Microware 200 Tens device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.

In particular, this device is indicated for use for:

• Symptomatic relief and management of chronic (long term) intractable pain. .
• Adjunctive treatment in the management of post surgical and post traumatic acute pain . problems.

Not Found

The provided text is a clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device (Microware 200, Microware 200 TENS, Microware TENS 200). It establishes the device's substantial equivalence to a predicate device.

However, the letter does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, or any details about a study design (sample sizes, ground truth, experts, adjudication, MRMC, or standalone performance).

The FDA clearance for this type of device (Transcutaneous Electrical Nerve Stimulator) is based on substantial equivalence to a predicate device, as stated in the letter: "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This typically means that the device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate. Clinical studies with detailed performance metrics and acceptance criteria for classification purposes are not always required for 510(k) clearances.

Therefore, I cannot populate the table or provide the requested study details from the given text.

Here's why each specific piece of information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not present. The letter doesn't mention specific performance metrics like sensitivity, specificity, or any quantitative measures for pain relief.
2. Sample sized used for the test set and the data provenance: Not present. No study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study data is mentioned.
4. Adjudication method: Not present. No study data is mentioned.
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 present. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is not an AI device, and no standalone performance data is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No study data is mentioned.
8. The sample size for the training set: Not present. No training set is relevant for this type of device and clearance process mentioned.
9. How the ground truth for the training set was established: Not present. No training set is relevant.

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