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I am sorry, but the provided text from the FDA letter and attachment does not contain information regarding the acceptance criteria for a medical device and the study that proves the device meets those criteria. The documents are a formal FDA communication about a 510(k) clearance for the ConMed™ VersaStim Neuromuscular Stimulator/TENS and its electrodes.

Specifically, the documents include:

• A letter granting 510(k) clearance, indicating the device is substantially equivalent to legally marketed devices.
• Information about regulatory requirements and general controls.
• An "Indications for Use" statement for the device.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• A study design or methodology.
• Sample sizes for test or training sets.
• Data provenance.
• Details about expert ground truth establishment or adjudication.
• Multi-Reader Multi-Case (MRMC) studies or their outcomes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, expert consensus, etc.).

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

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