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To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.

The Wand Plus™ is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible status indicators, including optional voice announcement, of injection rate, and volume of anesthetic dispensed.

This document describes a 510(k) submission for "The Wand Plus™ Syringe". The 510(k) summary (K992819) states that the device is "substantially equivalent" to the company's currently marketed "Wand™ computer controlled syringe." Generally, a 510(k) summary provides evidence of substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove they are met.

Given the information provided, a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information are not applicable or not present in the provided 510(k) summary document. This document primarily focuses on establishing substantial equivalence to a predicate device, which often relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text.

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