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The Ti-Max X Turbine Series is an air-powered dental handpiece intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

The Ti-Max X Turbine is an air-powered high-speed dental handpiece capable of reaching rotational speeds of 300,000 to 450,000 revolutions per minute. The device includes non-optic, fiber-optic, and LED models. Models are available to connect directly to the couplings of specific brands.

The provided document is a 510(k) premarket notification for a dental handpiece, the Ti-Max X Turbine. It focuses on establishing substantial equivalence to a predicate device based on similarities in intended use, principles of operation, functional design, and established medical use. It does not contain information on acceptance criteria for a performance study, nor does it present the results of such a study.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria.

The document states:
"The Ti-Max X Turbine was developed and is produced under consideration of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing."

This indicates that bench testing was performed to demonstrate conformance to relevant standards, but no specific performance metrics, acceptance criteria, or a detailed study report are included in this 510(k) summary.

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