(256 days)
The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use:
- · Relaxation of muscle spasms
- · Re-education of muscle
- · Prevention or retardation of disuse atrophy
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Increases local circulation
- · Maintains or increases range of motion
Stimulator waveforms: IFC, LVPC, and VMS:
· Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury.
Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use:
- Relieves pain
- · Decreases joint stiffness and contractures
- · Reduction of muscle spasm
- · Increases local circulation
- · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues
- · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the OmniVersa™ Multi-Modality Therapy System and Omnistim® FX2 Professional Therapy System does not contain information about acceptance criteria or a study proving a device meets these criteria in the context of AI/ML performance.
This document is a letter from the FDA determining substantial equivalence for a medical device (an ultrasound and muscle stimulator). It outlines:
- The trade/device name and regulatory classification.
- The indications for use of the device.
- Regulatory compliance requirements.
It does not include:
- Information about a study on device performance against specific acceptance criteria.
- Any mention of AI or machine learning.
- Details on sample sizes, ground truth, expert qualifications, or adjudication methods for any performance studies.
- Data on multi-reader multi-case (MRMC) comparative effectiveness or standalone algorithm performance.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text.
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator 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. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator 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 applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles 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 ultrasound and muscle stimulator 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 ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.