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The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Skylark Uro Probe." This document primarily focuses on regulatory approval and does not contain information about specific acceptance criteria for device performance, the results of a study proving those criteria were met, or details regarding the methodologies of such a study (sample sizes, ground truth establishment, expert qualifications, etc.).

The letter confirms:

• Trade/Device Name: Skylark Uro Probe
• Regulation Number: 21 CFR §876.5320
• Regulation Name: Nonimplanted electrical continence device
• Regulatory Class: II
• Product Code: KPI
• Indications for Use: The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

Therefore, I cannot provide the requested information from the given document as it does not contain the details about acceptance criteria or a study proving device performance.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that explicitly details the device's performance testing and the criteria it needed to meet.

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