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The UROSTYM™ Biofeedback and Stimulation Device Anal/Rectal Probes are used in treating urinary incontinence by way of perineal reeducation and stimulation. This device is a non-implanted electrical stimulator applied the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. These probes are provided non-sterile for single patient use/disposable. The probes are for office use under the direction of a physician or licensed health care professional.

The UROSTYM™ Biofeedback and Stimulation Device Anal/Rectal Probes are non-implanted electrical stimulators applied the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. These probes are provided non-sterile for single patient use/disposable.

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Urostym Anal/Rectal Stimulation Probes." This type of document declares a device to be substantially equivalent to a predicate device, allowing it to be marketed.

However, the letter and the associated "Indications for Use" page do NOT contain any information about acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with acceptance criteria and detailed performance metrics as might be found in a Premarket Approval (PMA) application or other types of device submissions.

Therefore, I cannot fulfill the request using the provided text. The document simply states that the FDA has reviewed the submission and determined the device is substantially equivalent to predicate devices for the stated indications for use.

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