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The Hier-Spec vaginal speculum is a non-metal (Acrylic and Polycarbonate), hand held device used to open the vagina and provide access to the cervix for gynecological or obstetrical examinations and procedures.

When the device is in the closed position, for insertion into the vagina, the bow arms are in a horizontal position and the handles are open to approximately 45 degrees. After the device is inserted into the vagina, the handles are squeezed together and the connecting rail rotates the bow arms into a horizontal position to open the vaginal canal.

This document is a 510(k) Summary of Safety and Effectiveness for the HierSpec Speculum, a disposable vaginal speculum. It describes the device, its intended use, and compares it to a predicate device (Welch Allyn Kleenspec®).

Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews.

The document's purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to present a standalone performance study with specific acceptance criteria and results. The "Performance Standards" section explicitly states "None," indicating that the manufacturer did not conduct a detailed performance study to meet specific numerical criteria for this submission.

Therefore, I cannot fulfill your request for the detailed table and study information because it is not present in the provided text.

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