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Pro-Dentec's VICTOR Interactive Probe is an automated periodontal probe intended for use during periodontal examinations to measure and chart the depth of a gingival sulcus in millimeters.

The device is a periodontal probe which is used by dental professionals during periodontal examinations. The device consists of a control unit, a transducer connected by a cable to the control unit and single use, disposable handpieces.

The provided document is a 510(k) summary for the Pro-Dentec VICTOR Interactive Probe, an Electronic Periodontal Probe. It describes the device, its intended use, and identifies a predicate device (Florida Probe K875076 and manual Michigan periodontal probes).

However, the document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert involvement, or any of the other specific details requested in your prompt.

This 510(k) summary focuses on establishing substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and intended use, rather than presenting detailed clinical performance data in the same way a de novo submission or a more comprehensive clinical trial report would.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.

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