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The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

The Orthosonics Duo-Son Ultrasound Diathermy Device consists of a two-channel power module which generates the ultrasonic energy and provides overall control of the device, and a handpiece with cable. The applicator design allows the simultaneous delivery of ultrasonic energy to tissue at two frequencies, 1 MHz and 45 kHz.

The Orthosonics Duo-Son Ultrasound Diathermy Device is a medical device intended to apply ultrasonic energy to generate deep heat within body tissues. Below is a breakdown of its acceptance criteria and the study performed, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance metrics in a traditional sense. The "acceptance criteria" here implicitly refer to meeting safety and effectiveness standards comparable to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in terms of human subjects or a clinical dataset. The testing described primarily involved laboratory-based evaluations using a "phantom." Therefore:

• Sample size for the test set: Not applicable in the context of human subjects. The tests were performed on a phantom.
• Data provenance: Not explicitly stated, but implicitly laboratory-based testing conducted by Orthosonics, Ltd. in the UK. This would be considered prospective, as the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for the device's performance was established through direct physical measurements on a phantom and compliance with regulations, not through expert review of data that required a ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in the context of data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not mentioned or implied in the provided text. The device is a physical therapy device (ultrasound diathermy), not an imaging or diagnostic device that would typically involve MRMC studies.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The testing described focuses on the device's inherent performance characteristics (electrical safety, EMC, temperature rise in a phantom) without human interaction influencing the core performance metrics being evaluated. The "algorithm" here refers to the device's functional operation.

7. The Type of Ground Truth Used:

The ground truth used was based on:

• Physical measurements: Directly measuring electrical safety, electromagnetic compatibility, and temperature rise in a phantom.
• Regulatory standards: Demonstrating compliance with 21 CFR 1050.
• Comparison to a predicate device: The performance observed in the Duo-Son device was compared against the known characteristics and performance of the legally marketed predicate device (Mettler Model ME-720) to establish substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is an ultrasound diathermy device, not an AI/machine learning algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no training set for an AI model.

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