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The CU580 is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the chair and attached dental devices. It delivers air, water, vacuum, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office.

It is for use by authorized persons in the practice of dentistry, prosthodontices, oral surgery, orthodontics, and oral hygeine.

The CU 580 is a dental treatment Center. It includes a Dental Patient Chair, Ilental units a Dental Operating light, and dental operator's stool.

It is designed according to the principles of Home Position Dentistry which a dentist can keep the best posture during an operation.

This document describes the 510(k) premarket notification for the J. MORITA MFG. CORP.'s Spaceline Emcia CU 580, a dental chair with an operative unit.

Based on the provided text, the device in question is a dental chair with an operative unit, not an AI or diagnostic device that would typically have performance criteria measured by metrics like sensitivity, specificity, or AUC, or involve a study with a ground truth established by experts.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets cannot be extracted from the provided text, as these concepts are not applicable to the type of device described.

The document focuses on demonstrating substantial equivalence to predicate devices (SIRONA C8 and Spaceline Feel 21) based on similar general intended uses, technological characteristics, and operating principles, rather than clinical performance metrics for a diagnostic or AI device.

Here's a breakdown of why the requested information is not available in the provided text:

1. Nature of the Device: The Spaceline Emcia CU 580 is a dental chair and operative unit. Its "performance" is related to its physical function, safety, and ability to deliver utilities (air, water, vacuum, electricity) for dental procedures, not diagnostic accuracy.
2. Regulatory Pathway: The submission is a 510(k) premarket notification, which, for this type of device, focuses on substantial equivalence to a legally marketed predicate device. This typically involves technical specifications, safety standards, and intended use comparison, not clinical trial performance with ground truth.
3. Lack of Clinical Study Details: The provided text does not mention any clinical studies designed to assess diagnostic accuracy or performance against a "ground truth." It only refers to a comparison with predicate devices to establish substantial equivalence.

In summary, the table and detailed study information cannot be created because the provided document does not contain the type of data requested for an AI or diagnostic device evaluation.

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