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The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.

The LSM Dental Unit is intended to supply power to and serve as a base for other dental services. The Dental Operative Unit includes an automatic control system, a water control for hand pieces and syringes, a 3 way syringe, instrument holder, mounting, vacuum system, foot control and utility box.

This document is an FDA 510(k) clearance letter for the "ADEC Dental Unit, Models Century Plus & Cascade, DCI Dental Unit" with product code EIA. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the information necessary to describe acceptance criteria, a study proving device adherence, or any of the detailed points requested in your prompt (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types for training/testing, or training set size/ground truth establishment).

The document is purely a regulatory clearance. It does not elaborate on the performance evaluation or testing used to achieve this clearance. For that information, you would typically need to refer to the actual 510(k) submission document itself, which is not provided here.

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