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Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.

PAIN MANAGEMENT

• For adjunctive treatment of post-traumatic pain syndromes .
• For management and symptomatic relief of chronic (long-term) intractable . pain and inflammation
• As an adjunctive treatment in the management of post-surgical pain . problems

MUSCLE STIMULATION

• Relaxation of Muscle Spasms .
• Prevention or Retardation of Tissue Atrophy .
• Increasing Local Blood Circulation ●
• Muscle Re-education
• Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous ● thrombosis
• . Maintaining or increasing range of motion

Not Found

The provided text is an FDA 510(k) clearance letter for the Axiom NVP8500, a powered muscle stimulator. This type of document declares substantial equivalence to a predicate device and does not involve the kind of detailed clinical study information about acceptance criteria and performance metrics that you are requesting.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

• Acceptance criteria beyond "substantial equivalence" to a predicate device.
• Specific device performance metrics from a study.
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This document is primarily concerned with regulatory clearance based on equivalence, not detailed performance study results against specific criteria.

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