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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

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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.

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