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The S.S. White Technologies 6500 Series Air Abrasion Devices are used for cavity preparation in Classes I, II, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. They are also used for restoration prophylaxis.

The 6500-D, 6500-E, and 6500-F are pneumatic devices which combine pressurized air and abrasive powder (e.g. aluminum oxide or sodium bicarbonate) to produce a high velocity stream of particles to perform dental restorative procedures. The abrasive particulate is delivered via a small handpiece which is approximately the size of a dental drill handpiece. The systems are designed for ease of service and maintenance with a readily accessible refillable container for the particulate supply.

This 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This submission is for a conventional medical device (dental instrument), not an AI/ML-enabled device, and therefore the regulatory requirements and documentation are different.

Specifically, the document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use and technical specifications. It does not present performance metrics, clinical study results, or a detailed breakdown of acceptance criteria as would be expected for an AI/ML-driven diagnostic or treatment planning system.

Therefore, I cannot populate the table or answer the questions as requested, because the provided text does not contain the necessary information regarding acceptance criteria and performance studies. The core of this 510(k) summary is a declaration of substantial equivalence, not a detailed performance validation study against predefined criteria for an AI model.

The document states: "Since the intended use and technical specifications of the 6500-D, 6500-E, and 6500-F are virtually identical to the predicate devices, and the differences in the devices only serve to make them marketable, we believe the 6500 Series devices are substantially equivalent to the predicate devices and can be marketed under section 510(k) of the FD & C Act."

This highlights that the basis for approval is comparative equivalence, not a standalone performance study with specific metrics.

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