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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 VISER™ penile tumescence monitor is a noninvasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISERTM is a prescriptive device to be used under the direction of a physician or other authorized health care professional.

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This document is a 510(k) clearance letter for the VISER™ Penile Tumescence Monitor. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The provided text does not include details about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information. These details are typically found in the 510(k) submission itself, which is not fully included here.

The letter explicitly states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA did not require a new clinical study to establish safety and effectiveness, but rather determined that the new device is as safe and effective as a device already on the market. Therefore, the detailed study information requested is not present in this clearance letter.

Without the actual 510(k) submission, it's impossible to answer the specific questions about acceptance criteria and study details.

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The Ano-Rectal Manometry (ARM) Option to Laborie's PC-based urodynamic systems is intended to be used in quantifying ano-rectal pressures. Using the same transducers as for urodynamics but with a different measuring range, the ARM Option can be used for performing standard ano-rectal manometric measurements.

Ano-rectal Manometry Option Device, Model UDS-ARM

The provided document is a 510(k) clearance letter from the FDA for a device called "Ano-rectal Manometry Option Device, Model UDS-ARM" and its Indications for Use statement. This document confirms the device's substantial equivalence to a predicate device but does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter is a regulatory approval document and focuses on stating that the device is substantially equivalent to a pre-amendments device, allowing it to be marketed. It does not include the detailed technical or clinical study data that would typically contain the information requested in your prompt.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, one would need access to the actual 510(k) submission (K963064) which would contain the performance data and methodology used to demonstrate substantial equivalence.

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