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The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Ultrasonic equipment generates high frequency sound waves that are transferred to a specific body area via a round-headed probe. The sound waves travel deep into tissue and create gentle heat. As the probe glides over the skin's surface, sound waves penetrate the skin's surface causing soft tissues to creating deep heat. In turn, the heat induces vasodilatation: drawing blood into the target tissues. The generated deep heat is found to help relieve pain and reduce muscle spasms.

The provided text is a 510(k) summary for the SUN-RAIN Ultrasonic Therapy devices (SU-300 to SU-900). It focuses on establishing substantial equivalence to a predicate device (SUN-RAIN Ultrasonic Therapy, SU-100 K024013) based on shared indications for use and power input, as well as compliance with electrical safety and electromagnetic compatibility standards.

Crucially, this document does not describe acceptance criteria relating to device performance for the purpose of a study, nor does it detail a study proving the device meets performance criteria.

Instead, it outlines the regulatory pathway for a medical device seeking market clearance in the US, primarily by demonstrating that the new devices are substantially equivalent to an already legally marketed predicate device. The information provided is primarily about safety and technical standards compliance, rather than a clinical performance study with acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study that proves the device meets those criteria, as this information is not present in the provided text.

Here's why each specific requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The document lists safety and electrical standards the device was tested against (e.g., IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-2-5, IEC 61689), but not performance acceptance criteria or specific performance results.
2. Sample size used for the test set and the data provenance: Not applicable. There was no clinical performance test described with a test set. The non-clinical tests relate to electrical and safety standards compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance test requiring expert ground truth was described.
4. Adjudication method for the test set: Not applicable. No clinical performance test requiring adjudication was described.
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 device is an ultrasonic therapy device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device in the context of AI.
7. The type of ground truth used: Not applicable. No clinical performance study requiring ground truth was described. The "ground truth" here would relate to compliance with electrical and safety standards.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory submission for an ultrasonic therapy device, emphasizing its substantial equivalence to a predicate device and compliance with relevant safety and electrical standards. It does not contain information about clinical performance studies, acceptance criteria for such studies, or data related to AI/machine learning device development.

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