(147 days)
The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for the HES® Ultrasonic Therapy Appliance, confirming its substantial equivalence to a legally marketed device for the stated indications for use.
The text does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any studies.
- Information on expert review, adjudication methods, or MRMC studies.
- Details about standalone algorithm performance or training sets.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.
§ 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.