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Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.
2. Pain relief, muscle spasms, and joint contractures.
3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
   • Adhesive capsulitis,
   • Bursitis with slight calcification,
   • Myositis,
   • Soft tissue injuries, and
   • Shortened tendons due to past injuries and scar tissues.
4. Relief of pain, muscle spasms, and joint contractures resulting from:
   • Capsular tightness, and
   • Capsular scarring.
5. Localized increase in blood flow.
6. Increased range of motion of contracted joint using heat and stretch techniques.

As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site. It is demonstrated ultrasound can be used to apply therapeutic deep heat for the treatment of medical conditions including relief of pain, muscle spasms, and joint contractures.

It is intended to be used for 30 minutes per cycle (up to 4 cycles) in the home or clinical/hospital setting by or under the direction of a medical professional to apply ultrasound to the patient's treatment site. The device automatically alerts the patient in case of improper application or performance. All the control components and the rechargeable battery of the device are protectively housed, and the device is connected to one or two applicators of ultrasound.

The subject device consists of the main device, the applicator, the charger/adapter, the liquid and/or solid ultrasound gel, and the sticky pad. For the best result, use the ultrasound gel and the sticky pad supplied.

This looks like a fascinating case study. Based on the provided FDA 510(k) clearance letter and summary, here's an analysis of the acceptance criteria and the study that proves the device meets them.

It's important to note that this document is for an Ultrasound Stimulator (Ultrasonic Diathermy), which delivers therapeutic ultrasound, not an AI/Software as a Medical Device (SaMD) that typically involves image analysis or diagnostic support. Therefore, many of the typical acceptance criteria and study designs related to diagnostic accuracy, MRMC studies, and nuanced ground truth establishment for AI models (as implied by the original request's detailed points) are not applicable to this type of physical therapy device.

The "acceptance criteria" here are primarily based on demonstrating substantial equivalence to predicate devices through engineering specifications, performance testing, and safety profiles, rather than clinical efficacy studies in the way an AI diagnostic tool would require.

Acceptance Criteria and Study Proving Device Meets Criteria

Given that the device is an Ultrasound Stimulator aiming for 510(k) clearance based on substantial equivalence, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) but rather in terms of demonstrating that its technical characteristics, performance, and safety are equivalent to legally marketed predicate devices. The "study" proving it meets these criteria is a comprehensive set of non-clinical, bench performance tests and comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

For an Ultrasound Stimulator, the "acceptance criteria" are primarily a demonstration of equivalence to the predicate devices across various technical and functional parameters, and compliance with relevant safety standards. The "reported device performance" are the results of the non-clinical tests and direct comparisons to the predicate devices.

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