(88 days)
Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. The Intelect Legend Ultrasound, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45 °C in all of its operating modes.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Chattanooga Group, Inc. regarding their Intelect Legend Ultrasound device from 1997. This document primarily focuses on the regulatory clearance of the device based on substantial equivalence to pre-amendment devices. It does not contain information about acceptance criteria, detailed study designs, performance metrics, ground truth establishment, or sample sizes typically found in modern AI/ML device submissions.
Therefore, I cannot extract the requested information as the document does not describe any specific acceptance criteria or a study that proves the device meets those criteria.
The letter states that the device can provide therapeutic deep heating between 40° and 45°C, but this is a characteristic of the device's function, not a performance metric from a study against specific acceptance criteria in the context of an effectiveness study.
To answer your request based on the provided text, I must state that the information is not available in these documents.
§ 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.