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The DELSONIC 2000 Ultrasonic Scaler is intended to be used fast and reliable removal of light to heavy calculus and plaque. This 29kHz ultrasonic system provides automatic tuning for each scaling insert.

The DELSONIC 2000 is an automatically tuned piezo ultrasonic scaler that generates linear tip movement at 29kHz for efficient, yet gentle calculus removal. The DELSONIC piezo ultrasonic scaler is designed for the prevention of crossinfection with fully autoclavable handpiece sleeves sterlisible removable control knobs and wipe clean display panel

The provided text is a 510(k) summary for the Delsonic 2000 Ultrasonic Scaler. It does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

The document is a submission to the FDA for market clearance, stating the device's substantial equivalence to a predicate device (Dentsply). It describes the device, its intended use, and its classification. The subsequent pages are the FDA's response letter granting market clearance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information is not present in this document.

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This unit combines both ultrasonic scaling and airpolishing functions in one compact unit that answers all prophylaxis needs. The air polishing function is intended to be used to remove stubbern stains, plaque and soft debris. The scaler funtions is intended to be used for cauculus removal. Device applications: Routine oral prophylaxis, routine polishing especially in hard to reach fissures and interproximal areas, prior to enamel etching and bonding techiniques and prior to bonding orthodontic bands and brackets.

Jetsonic 2000 combines both ultrasonic scalling and air polishing functions in one compact unt that answers all prophylaxis needs.

I am sorry, but the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Jetsonic 2000 Ultrasonic Scaler and Air Polishing Unit). It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device. However, it does not include details about device performance metrics, clinical studies, sample sizes, expert involvement, or ground truth establishment.

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The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures.

The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures. The arm system the control head is affixed to consists of three pieces. The first section is a rigid arm that mounts on a two inch outside diameter post. Attached to the end of the rigid arm section is a flex arm section that allows for vertical positioning. The flex arm section contains a pneumatic brake that helps provide positive positioning. The third piece is a control mount that allows flexibility in the horizontal positions. The delivery system provides connections for three pneumatically operated instruments. The common instrument used is the dental handpiece. The unit provides automatic instrument selection by means of a three way pneumatic valve located in each instrument hanger assembly. The automatic selection takes place when a static air pressure signal is removed from the top of a diaphragm located in the handpiece control block. The actual activation of the instrument is initiated by pressing on a foot containing a three way pneumatic valve. The delivery system also provides an air and water syringe for use as the dental procedure may require. The air and water syringe has an autoclavable syringe tip. The control also houses a master on/off control. air volume adjustments for the pneumatic instruments, water coolant volume adjustments, flex arm brake toggle, and an air coolant volume adjustment. There is also a toggle valve located on the control that allows for water purging of the water coolant lines that supply the pneumatic instruments with water coolant. The air and water utilities are are supplied through polyurethane tubing housed in a flexible umbilical.

The provided text is a 510(k) summary for the SDS Model 1400 XL Deluxe Dental Delivery System. This document describes a dental delivery system and its components, not a device that uses AI or requires specific performance criteria measured by a study in the way requested.

Therefore, I cannot extract the information requested regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types. These concepts are relevant to the evaluation of diagnostic or AI-powered medical devices, which this dental delivery system is not.

The document describes the physical characteristics, function, and materials of a dental chair-mounted unit. It focuses on its design, connections for instruments, utility requirements, and comparison to generic components in the dental industry.

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