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For TENS and Neuromuscular Stimulation

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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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This device is a 'combination' device and has the same indications for use as two different types of predicate devices.

High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.

• Relaxation of muscle spasms ●
• Prevention or retardation of disuse atrophy .
• Increasing local blood circulation ●
• Muscle re-education .
• Maintaining or increasing range of motion ●
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ●

Interferential Stimulators have one additional indication for use:

Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.

Not Found

This document is a 510(k) clearance letter from the FDA for a device named "Surgi Stim". It confirms that the device is substantially equivalent to predicate devices and can be marketed. However, this document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of a study that proves the device meets specific performance criteria.

The letter focuses on the regulatory clearance process and states the "Indications For Use" for the Surgi Stim device which is a combination of High Volt Pulsed Galvanic Stimulators, Neuromuscular Electrical Stimulators, and Interferential Stimulators.

Therefore, I cannot answer your specific questions based on the provided text. The document does not describe a study or provide performance data.

Ask a specific question about this device