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Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.

Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.

This document outlines the substantial equivalence of the "Elements™" dental impression material to a predicate device, "Take 1 (K091613)", based on non-clinical performance testing. It does not describe a study involving an AI-powered medical device or human readers. Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving an AI device meets those criteria.

The provided text focuses on the following:

• Device: Elements™ (dental impression material)
• Predicate Device: Take 1 (K091613)
• Purpose: To demonstrate substantial equivalence for FDA 510(k) clearance.
• Study Type: Non-clinical performance testing based on ISO 4823-2000.
• Key Finding: "No clinical testing was performed."

Since the request is about an "AI device" and "how much human readers improve with AI vs without AI assistance," the provided document is irrelevant to answering those specific questions. The document details the physical properties and a comparison of a traditional dental material, not an AI or software as a medical device.

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