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The Kolplast Vaginal Speculum is a disposable plastic speculum used to expose the interior of the vagina.

Kolplast Vaginal Speculum

The provided text does not contain any information about acceptance criteria or a study proving a device meets those criteria.

The document is a US FDA 510(k) clearance letter for the Kolplast Vaginal Speculum. It states that the device is substantially equivalent to a pre-amendments device and can be marketed. It discusses regulatory classifications, general controls, and contact information for further inquiries.

Therefore, I cannot fulfill the request to provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, or study details. This information is simply not present in the provided text.

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