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The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.

The OBP Office-Spec Disposable Side Speculum is indicated for use on women undergoing a procedure requiring vaginal access and exposure (e.g., for a pelvic exam or Pap smear). The device uses opposing bi-valve plastic blades to separate the vaginal wall and is intended to expose the interior of the vagina and exterior of the cervix. It may be used with or without a removable light source.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to OBP Corporation regarding their "OBP Office-Spec Disposable Side Speculum."

It primarily communicates the FDA's determination of substantial equivalence for the device to legally marketed predicate devices and outlines the regulatory requirements the company must comply with. The "Indications for Use" section describes what the device is intended for, but it does not include performance metrics, study details, or acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the provided input.

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