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Ultrasound delivered to the body using an efficient couplant provides deep heating effects to body tissues. Ultrasound delivered at a frequency of 1 MHz penetrates to a depth of approximately 5 centimeters while ultrasound at a frequency of 3.3 or 3.2 MHz penetrates tissue to a depth of approximately 1-2 cm.

When therapeutic ultrasound is delivered to the body at intensities capable of generating a deep tissue temperature increase, some or all of the following effects may occur:

• 1. Pain relief
• 2. Reduction of muscle spasm
• 3. Localized increase in blood flow
• 4. Increase range of motion of contracted joints using heat and stretch techniques.

Sonicator® 740, Model ME 740

The provided text is a 510(k) premarket notification letter from the FDA for a device named Sonicator 740, Model ME 740, which is an ultrasonic diathermy device. This document does NOT contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance is based on its substantial equivalence to existing predicate devices, not on a new clinical study demonstrating specific performance metrics. The document details the regulatory classification, product code, and indications for use, but does not provide any data from a study that would include acceptance criteria for metrics like sensitivity, specificity, or F1-score, nor does it discuss sample sizes, ground truth establishment, or expert reviews as would be typical for studies evaluating AI/ML-driven diagnostic devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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