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This device is for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).

The uresta™ Pessary is designed for adult women who experience involuntary urine loss from the most common type of incontinence; stress incontinence, from physical activity such as coughing, laughing and/or exercising. uresta™ Pessary is a bell-shaped vaginal pessary with a handle at its base for easy insertion and removal. uresta™ Pessary stops leaking from the bladder by supporting the urethra. The narrow tip allows for easy insertion into the vaginal introitus. It is inserted directly into the vagina like a tampon and seats itself so that the wide base provides support to the urethra. It is made of medical grade injection moulded Santoprene (non-latex thermoplastic rubber). uresta™ Pessary is available individually in sizes1 (30 mm), 2 (34 mm), 3 (38 mm), 4 (43 mm), 5 (48 mm), 6 (52 mm). The products are sold individually, and as a kit including one each of sizes 3, 4, 5, the most commonly used sizes.

This looks like a 510(k) premarket notification for a medical device (uresta™ Pessary) and does not contain information about acceptance criteria or a study proving the device meets them.

The provided text is primarily administrative, detailing the device's manufacturer, contact information, classification, predicate devices, a brief description of the device and its intended use, and the official FDA clearance letter.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in a clinical study report or a more detailed technical report submitted as part of the 510(k) application, but it is not present in the provided summary documents.

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