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Global GDCH - 2000 is a dental operative unit attached to patient chair. The dental operative unit is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device also functions to deliver air, water and vacuum to the dental devices/accessories. The device is attached to dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.

The Global GDCH - 2000 is a dental operative unit attached to a dental patient chair. The design is very flexible with many functions, both left-handed and right-handed use is easily obtainable. The dentist and assistant are allowed to change their working postures and positions according to the operation to be performed. The versatile swiveling function enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use.

The provided text describes a 510(k) premarket notification for a dental operative unit (Global GDCH-2000). However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, or any studies (such as clinical trials, standalone studies, or MRMC studies) that would typically be used to demonstrate the device meets such criteria.

The submission focuses on establishing substantial equivalence to a predicate device (Adec 532 Delivery System #K032756) based on similar design, composition, function, technological characteristics, and conformity to external standards (UL 60601-1 and CSA-C22.2 No. 601.1-90).

Therefore, I cannot provide the requested table and study details. The document explicitly states:

• "Comparable non-clinical tests have been conducted (such as Encl. 13 -- Appendix 8-1 attached from an accredited testing laboratory)." However, the details of these tests, their acceptance criteria, and specific performance results are not included in the provided text.
• The FDA's response confirms the substantial equivalence determination but does not elaborate on specific performance data beyond regulatory compliance.

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and device performance studies.

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