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The COMFORTdrive 200XDA Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.

The COMFORTironic 4894 is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. They are designed for use by a trained professional in the field of general dentistry.

The COMFORTarive 200XDA Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by an integrated electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The COMFORTtronic 4894 dental control unit is a stand-alone system for operating electrically-driven handpieces such as the COMFORTdrive 200XDA. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip/cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist.

The provided documents are 510(k) summaries for two dental devices: the COMFORTdrive 200XDA Handpieces and the COMFORTtronic 4894. These are submissions to the FDA to demonstrate substantial equivalence to existing legally marketed devices, rather than studies designed to prove a device meets specific acceptance criteria through performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from these documents.

The documents focus on:

• Device Name: COMFORTdrive 200XDA Handpieces and COMFORTtronic 4894
• Common Name: Dental Handpiece and Accessories, Operative Dental Unit
• Classification Name: Handpiece, AC-Powered, Dental (21 CFR § 872.4200); Operative Dental Unit and Accessories (21 CFR § 872.6640)
• Intended Use:
  • COMFORTdrive 200XDA Handpieces: For removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces by a trained professional in general dentistry.
  • COMFORTtronic 4894: To convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces by a trained professional in general dentistry.
• Predicate Devices:
  • COMFORTdrive 200XDA Handpieces: A-dec/W&H, Synea Air-Driven Highspeed Handpieces (K070663)
  • COMFORTtronic 4894: Bien Air., Optima MX (K042759) and Sirona Dental Systems GmbH. Sirotorque L (K031584)
• Substantial Equivalence: Asserted based on identical intended use and similar design, application, function, and technical characteristics to the predicate devices.

There is no data presented in these 510(k) summaries that describes: performance metrics, acceptance criteria, study sizes, ground truth establishment, expert involvement, or any form of comparative effectiveness study. These types of details are typically found in more extensive technical reports or clinical study summaries, which are not part of the provided 510(k) summary text.

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