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Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. VitalStim waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are: The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Non-mechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional. VMS™ waveform is a square symnetrical biphasic waveform with the application for use on the musculature of the face, The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation VMS™ waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function. HVPC™ waveform is a very brief pulsed monophasic waveform with the application for use on the musculature of the face. The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation High Volt Pulsed Current (HVPC) waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in posttraumatic conditions or after neurological insult with impaired neuromuscular function. sEMG™ is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are: The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.

Vitalstim Experia therapy is a comprehensive electrotherapy device for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended use is achieved by the benefit of powered muscle stimulation and muscle activity biofeedback in one comprehensive device. The intended patient outcome is to regain control of muscles to swallow food without aspirating.

VitalStim™ waveform is a square symmetrical biphasic waveform with interphase interval pulse with the application for use on the swallowing musculature in the anterior portion of the neck. The intended uses are: The VitalStim waveform intended uses are muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Non-mechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional.

VMS™ waveform is a square symnetrical biphasic waveform with the application for use on the musculature of the face, The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation VMS™ waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function.

HVPC™ waveform is a very brief pulsed monophasic waveform with the application for use on the musculature of the face. The intended uses are: Optional application of sEMG biofeedback with Muscle Stimulation High Volt Pulsed Current (HVPC) waveform for prevention or retardation of disuse atrophy, for muscle re-education, and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in posttraumatic conditions or after neurological insult with impaired neuromuscular function.

sEMG™ is surface biofeedback for use on the swallowing musculature of the face and/or anterior portion of the neck. The intended uses are: The sEMG intended uses are surface electromyography biofeedback for relaxation training and muscle re-education.

The provided text describes a 510(k) premarket notification for the Vitalstim Experia device. This review is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving device performance in the typical sense (e.g., accuracy, sensitivity, specificity) is not explicitly present.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The submission does not define explicit performance-based acceptance criteria in terms of metrics like accuracy, sensitivity, or specificity, nor does it report such performance. The primary "acceptance" is based on demonstrating substantial equivalence to legally marketed predicate devices.

The acceptance criteria implicitly relate to:

• Safety and Effectiveness: Demonstrated through compliance with recognized consensus standards (UL 60601-1: 2003, IEC 60601-1-2: 2001) for electrical and electromagnetic safety.
• Intended Use and Technology: The device's waveforms and intended uses (VitalStim, VMS, HVPC, sEMG) are compared to the predicate devices.
• Accessories: The use of special patient electrodes and lead wires.
• Certification Program: Recommendation for healthcare provider certification.

There is no quantitative performance data reported in the document that would typically be presented in a table for device performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical test set or data provenance is mentioned as this is a 510(k) submission focused on substantial equivalence to existing devices rather than a new clinical performance study. The "test set" in this context refers to the comparison against predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for this submission is based on regulatory compliance and the established safety and effectiveness of the identified predicate devices, as approved by the FDA. There is no mention of experts establishing a ground truth for a test set of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring an adjudication method. The review process involved the FDA evaluating the submission against regulatory requirements and comparison to predicate devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrotherapy device (powered muscle stimulator and biofeedback device), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic or AI-based device. It is a physical medical device delivering electrotherapy and biofeedback.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in the context of this 510(k) submission is the established regulatory compliance and presumed safety and effectiveness of the predicate devices. The submission asserts that the Vitalstim Experia is substantially equivalent to these already-approved devices, implying that their established 'truth' (i.e., that they are safe and effective for their intended use) extends to the new device.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. Since there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.

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