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The UROSTYM ™ Biofeedback and Stimulation Device is used for treating urinary incontinence by way of perineal re-education.. The Urostym probes are non-implanted electrical devices applied to the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. The probes and patches are provided nonsterile for single (individual) patient use / disposable. The probes are for office or hospital use under the direction of a physician or other licensed healthcare professional.

UROSTYM™ Biofeedback and Stimulation Device and Accessories

The provided document is a 510(k) summary for a medical device (UROSTYM™ Biofeedback and Stimulation Device and Accessories) and does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and is cleared for market.

Therefore, an answer fulfilling the request cannot be generated from the given text.

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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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The UROSTYM™ Biofeedback and Stimulation Probes are indicated for use in Treating urinary incontinence by way of re-education and stimulation. The UROSTYM non-implanted electrical Stimulation applied to the pelvic floor musculature and surrounding Pelvic Structures for therapy in the Treatment of urinary Incontinence. The probes are provided for single patient use/disposable. The non-steril probes are for office use under the direction of a physican or licensed health care professional.

UROSTYM™ Biofeedback and Stimulation Device - Vaginal Probe Models 3AT2B and TP2B

I'm sorry, but the provided text from the FDA letter and the "Indications For Use" form for the UROSTYM™ Biofeedback and Stimulation Device does not contain any information about acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested table or the details about a study, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided text.

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The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.

UROSTYM™ Biofeedback and Stimulation Device

This document is a 510(k) clearance letter from the FDA for the UROSTYM™ Biofeedback and Stimulation Device. It does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information for marketing the device.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device