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External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

(EMS) Electrical Neuromuscular Stimulator Model BMLS03-1

This document is a 510(k) premarket notification from the FDA, indicating that the Electrical Neuromuscular Stimulator Model BMLS03-1 is substantially equivalent to legally marketed predicate devices. This type of document does not contain acceptance criteria or a study proving device performance as typically expected for demonstrating AI/ML device efficacy.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific acceptance criteria and outcome data often associated with AI/ML device evaluations.

The information you've asked for (e.g., sample size for test set, ground truth methods, MRMC studies) is typically found in clinical trial reports or performance validation studies, which are not part of this 510(k) clearance letter.

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