(128 days)
Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
- Relief of pain
- Muscle spasms
- Joint contractures
But NOT for the treatment of malignancies
Not Found
The provided text is a 510(k) premarket notification approval letter for the Rich-Mar Therasound 6.5 Therapeutic Ultrasound device. It does not contain information about acceptance criteria, study details, performance metrics, ground truth, sample sizes, or expert qualifications as typically found in a clinical study report or a more detailed technical submission.
The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It lists the "Indications For Use" which are the conditions for which the device is intended (relief of pain, muscle spasms, joint contractures, but not for the treatment of malignancies), but these are not acceptance criteria in the sense of performance thresholds.
Therefore,Based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: This document is an FDA approval letter, not a study report. It does not contain specific acceptance criteria for device performance or reported performance metrics.
- Sample sized used for the test set and the data provenance: No study details are provided, so sample size and data provenance are unknown.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment method is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this device is a therapeutic ultrasound, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory approval notice based on substantial equivalence to existing devices, not a scientific study detailing device performance against specific criteria.
§ 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.