(239 days)
- Relief or reduction of pain;
- Reduction of muscle spasm;
- Joint contracture; and
- Local increase in circulation.
Not Found
The provided FDA 510(k) summary for the Accusonic Advantage Model AA170 does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data.
The document is a substantial equivalence determination letter, indicating that the device is similar enough to previously approved devices that it does not require a new premarket approval application. This type of FDA letter typically refers to information submitted by the manufacturer, but the letter itself does not detail the studies or criteria used.
Therefore, for each of your requested points, the answer is:
- A table of acceptance criteria and the reported device performance: This information is not provided in the document.
- Sample size used for the test set and the data provenance: This information is not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
- Adjudication method for the test set: This information is not provided in the document.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided in the document. The device is an ultrasonic diathermy device, not an AI diagnostic tool, so an MRMC study for AI assistance would not be applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided in the document. The device is a physical therapy device and not a standalone diagnostic algorithm.
- The type of ground truth used: This information is not provided in the document.
- The sample size for the training set: This information is not provided in the document.
- How the ground truth for the training set was established: This information is not provided in the document.
§ 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.