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The MediPhysics Pain Treatment System, Model 1, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

The McdiPhysics Pain Treatment System, Model 1, consists of a control console, two Treatment Probes (electrodes), and a Security Cartridge. The system operates on 115V wall current. Treatment, intended to take place under the supervision of a physician in a medical setting, consists of applying very low current to painful tissue and associated trigger points with the Treatment Probes.

The MediPhysics Pain Treatment System, Model 1, did not undergo a study to demonstrate its performance against specific acceptance criteria in the provided document. Instead, its market clearance (K032928) was based on a substantial equivalence determination to legally marketed predicate devices.

The document does not provide information on:

• Specific acceptance criteria used for validation.
• The results of any performance study against defined criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, adjudication methods, or ground truth establishment.
• MRMC comparative effectiveness studies or standalone algorithm performance.

The key statement regarding performance testing is:

"The MediPhysics Pain Treatment System, Model 1, has been systematically tested and test results demonstrate that it fulfills design and performance specifications."

However, no details about these "design and performance specifications," the "systematic testing," or the "test results" are provided. The FDA's letter (K032928) explicitly states that clearance was granted because the device was found substantially equivalent to predicate devices for its intended use, based on its design and technological characteristics, and that "the differences between the MediPhysics Pain Treatment System, Model 1, and cited predicate devices are minor and raise no new issues of safety or effectiveness." This indicates that a head-to-head clinical performance study with predefined acceptance criteria, as typically seen for novel devices, was not required or submitted for this 510(k) clearance.

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