(153 days)
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.
| Acceptance Criteria Category/Issue Addressed | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Results supported the safety and effectiveness of the device. |
| Electromagnetic Compatibility | Results supported the safety and effectiveness of the device. |
| Temperature Rise in a Phantom (Duo-Son) | Results supported the safety and effectiveness of the device and demonstrated substantial equivalence. |
| Temperature Rise in a Phantom (Predicate) | Used for comparison to demonstrate substantial equivalence to the predicate device (Mettler Model ME-720, K883228). |
| Compliance with 21 CFR 1050 | Results supported the safety and effectiveness of the device. |
| Substantial Equivalence to Predicate | Demonstrated through performance tests and comparison of characteristics, the device is substantially equivalent to the Mettler Model ME-720 (K883228). |
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.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate 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.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.