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The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Incontinence Treatment Device, Model LT2061

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "Incontinence Treatment Device, Model LT2061," stating that the device is substantially equivalent to legally marketed predicate devices.

The text describes:

• The FDA's review and determination of substantial equivalence.
• Regulatory requirements that the device manufacturer must comply with (e.g., registration, listing, labeling, quality systems, medical device reporting).
• Indications for Use for the device.
• Contact information for FDA resources.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study design, sample sizes, data provenance, or ground truth establishment.
• Information on expert panels, adjudication methods, or MRMC studies.
• Any performance metrics or statistical results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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