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The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

This is a 510(k) premarket notification for a dental handpiece, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, expert involvement, MRMC study, standalone performance, ground truth, and training set is not applicable.

The provided document describes the substantial equivalence determination for:

• Trade Name: Elite Low Speed Air Motor with Elite "E" Contra-angle, Medidental High Speed Handpiece
• Common Name: Air-powered Low Speed Handpiece, E Type contra-angle, Air-powered High Speed Handpiece
• Classification Name: Handpiece, Air-Powered Dental
• Product Code: EFB (later listed as EFA in the FDA letter, which could be a typo or an update)

The device is intended to power various attachments for dental procedures such as removing carious material, excess filling material, cavity and crown preparation, root canal preparations, restoration, and polishing teeth.

The device was found substantially equivalent to the predicate device:

• Predicate Device: High & Low Speed Handpiece, with E-Type contra-angle (K073652) manufactured by NAKAMURA MAGNIFIER CO., LTD.

The FDA's review for such devices typically focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device to ensure it is as safe and effective. This generally involves mechanical and performance testing relevant to its function as a dental handpiece, such as speed, torque, vibration, noise, and compatibility with attachments, but not AI/ML-specific metrics.

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The intended use of the Air Schic Scaler is intended for use by dental professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits from teeth.

The Air Sonic Scaler, is intended for use by medical professionals during cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a surgical 440A stainless steel tip, The tip comes in 3 different shapes (AS1, AS2, AS3) and is designed to generate a vibrating frequency of 6,000 Hz.

The provided document is a 510(k) premarket notification for an Air Sonic Scaler. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance.

Therefore, I cannot provide the requested information based on the given text. The text does not detail any performance studies, test sets, expert involvement, adjudication methods, or specific ground truths for evaluating the Air Sonic Scaler's performance against defined acceptance criteria.

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