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The Spirit Dental Operative Units are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to hand held dental instruments. The Spirit Dental Operative Units are intended for use by professional dental practitioners in providing treatment in a dental operatory.

The Spirit Dental Operative Units serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, foot control, and a junction box that houses a power supply and air/water regulators. Various Handpieces and accessories can be added to the Spirit Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them into the Sprit Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments.

The provided text is a 510(k) Summary for a dental operative unit, not a study describing AI device performance. Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

This document focuses on establishing "substantial equivalence" to a predicate device for regulatory approval, primarily through non-clinical testing and comparison of technical specifications, rather than presenting a performance study of a device against specific acceptance criteria in the way you've described for an AI-powered medical device.

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