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The Popspek™ Vaginal Speculum is intended for exposing the interior of the vagina and for measurement of vaginal prolapses.

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I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) clearance letter from the FDA for a device called "PopSpek™ Disposable Adjustable Vaginal Speculum." This letter:

• Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as another legally marketed device, but it does not detail specific performance studies or acceptance criteria that were met.
• Identifies the device and its intended use: It clearly defines the device's name and its "Indications for Use," which are "for exposing the interior of the vagina and for measurement of vaginal prolapses."
• Specifies regulatory information: It provides the regulation number, product code, and regulatory class.
• Outlines general controls: It reminds the applicant of general controls provisions of the Act that they must comply with.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or expert qualifications for any study.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or details about training sets.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

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