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For evaluation of the status of muscles at rest and in function. As an aid in muscle re-education and muscle relaxation therapy. Provides ability to compare new captured data with past data to assess progress in treating patient's relaxation state.

The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle. The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described in the Special 510(k).

The provided text is a 510(k) summary for the Norodyn 8000 SEMG System and an FDA clearance letter. It outlines the device's purpose and its substantial equivalence to other legally marketed devices, specifically regarding the addition of Fast Fourier Transformation (FFT) to its software.

However, this document does not contain any information about acceptance criteria, device performance metrics, or a study (clinical or otherwise) that proves the device meets specific acceptance criteria. It is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.

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

To be clear:

• There is no table of acceptance criteria and reported device performance.
• There is no sample size used for a test set.
• There is no data provenance mentioned.
• There is no mention of experts establishing ground truth.
• There is no adjudication method described.
• There is no MRMC comparative effectiveness study mentioned.
• There is no standalone performance study described.
• There is no type of ground truth mentioned for any performance evaluation.
• There is no sample size for a training set.
• There is no information on how ground truth for a training set was established.

The document's purpose is to argue for substantial equivalence based on technological characteristics, not to provide detailed performance metrics against pre-defined acceptance criteria.

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