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The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including:

A. Implant placement , including

• 1. Preparation of the osteotomy site
• 2. Bone contouring , osteoplasty
• B. Periodontal surgeries
• 1. Bone contouring & alveoplasty around living teeth
• 2. Removal of exostosis
• C. Bone grafting
• 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions

The TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

The provided text is an FDA 510(k) Premarket Notification for a dental handpiece. It details the device's indications for use, technological characteristics, and comparison to a predicate device to establish substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop performance study.

The "studies" mentioned are:

• Biocompatibility testing (following ISO standards) to ensure material safety.
• Bench testing (to ISO 14457) to ensure mechanical performance and compliance.
• Sterilization validation (following FDA guidance, ASTM, and ISO standards) to confirm effective reprocessing.

These are standard engineering and safety tests for a medical device like a dental handpiece, not performance studies assessing diagnostic accuracy or human performance with or without AI assistance. The device in question is a physical dental instrument, not a software algorithm for diagnostic image analysis.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of AI/human-in-the-loop performance, as the provided text does not contain this information for this type of device.

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