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To retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.

G-SpecTM Articulated Weighted Vaginal Speculum is supplied with single use disposable blades that attached to a 2 pound stainless steel weighted speculum handle. The disposable blades are supplied in three sizes: 9, 11, and 13 centimeters And can be set to three positions relative to the weighted handle: 90, 80, and 70 degrees The disposable blades snap fit into the reusable weighted speculum handle and are discarded after each use. The reusable weighted speculum handle is reusable and may be cleaned and resterilized.

The provided text is a 510(k) summary for the G-Spec™ Articulated Weighted Vaginal Speculum. It describes the device, its intended use, and its technological characteristics as compared to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The document states:
"The G-SPEC™ Articulated Weighted Vaginal Speculum has the same intended use and the same basic technology as the predicates identified in the premarket notification submission. The new device contains in some combination similar/same features, materials, and design as the predicates and does not pose any new questions concerning safety and effectiveness."

This indicates that the device's approval was based on demonstrating substantial equivalence to already legally marketed predicate devices, rather than through a new clinical performance study with specific acceptance criteria that would typically be seen for AI/ML devices or novel technologies.

Therefore, I cannot provide the requested information, as it is not present in the provided text. No direct device performance studies were conducted or reported in this 510(k) summary.

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