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Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

• Relief of pain
• Muscle spasms
• Joint contractures
  But NOT for the treatment of malignancies

Not Found

The provided text is a 510(k) premarket notification approval letter for the Rich-Mar Therasound 6.5 Therapeutic Ultrasound device. It does not contain information about acceptance criteria, study details, performance metrics, ground truth, sample sizes, or expert qualifications as typically found in a clinical study report or a more detailed technical submission.

The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It lists the "Indications For Use" which are the conditions for which the device is intended (relief of pain, muscle spasms, joint contractures, but not for the treatment of malignancies), but these are not acceptance criteria in the sense of performance thresholds.

Therefore,Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This document is an FDA approval letter, not a study report. It does not contain specific acceptance criteria for device performance or reported performance metrics.
2. Sample sized used for the test set and the data provenance: No study details are provided, so sample size and data provenance are unknown.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment method is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this device is a therapeutic ultrasound, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory approval notice based on substantial equivalence to existing devices, not a scientific study detailing device performance against specific criteria.

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