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The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure biofeedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence.

The evadri Bladder Control System is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in an office, clinic, or hospital. The evadri office prisitials, maros marse entronyography or pressure biofeedback from pelvic musculature. The device also provides electrical stimulation to the pelvic musculature. The modalities of biofeedback and electrical stimulation are intended for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of incontinence.

I am unable to provide a description of the acceptance criteria and study as the provided text does not contain that information. The document is a 510(k) summary for a medical device (evadri Bladder Control System), which primarily focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

The document includes:

• Sections 1-6: Details about the sponsor, device name, predicate devices, detailed description of the evadri Bladder Control System (including technological characteristics for stimulation and biofeedback).
• Section 7: A conclusion stating that the device is safe and effective and substantially equivalent to identified predicate devices.
• FDA Letter: A letter from the FDA confirming the 510(k) clearance and the device's substantial equivalence.
• Statement of Intended Use: A reiteration of the device's intended use.

There is no mention of specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement in a performance study within the provided text.

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