(133 days)
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 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
This document is a 510(k) clearance letter for the Axiom EPS8000 device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics.
The letter states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means the device is considered as safe and effective as a legally marketed device that was on the market prior to May 28, 1976, or has been reclassified.
Therefore, I cannot provide the requested information based on the provided document. The details about acceptance criteria, device performance results, study sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets, and how ground truth was established are typically found in the 510(k) submission itself or in relevant scientific studies, not in the FDA clearance letter.
The clearance letter focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting a detailed performance study against predefined acceptance criteria.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).