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The "Surestim" is an electrical powered muscle stimulator used to apply an electrical current through electrodes to a patient's skin for the relaxation of muscle spasms.

The "Surestim" is an electrical powered muscle stimulator.

The provided document is a 510(k) premarket notification letter from the FDA for a device named "Surestim," a powered muscle stimulator. This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, or performance evaluation as would be found in a clinical trial report or a technical performance study.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Details of standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

This letter solely confirms that the "Surestim" device is considered "substantially equivalent" to legally marketed predicate devices for the indicated use of "relaxation of muscle spasms." The FDA's substantial equivalence determination primarily focuses on whether a new device is as safe and effective as a legally marketed device, not on presenting novel study data proving performance against specific acceptance criteria.

To obtain the requested information, one would need to refer to the original 510(k) submission (K011588) by Suretone International, which would contain the technical and clinical data relied upon for the substantial equivalence determination. However, this letter itself does not provide such details.

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