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The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is composed of the aforementioned corresponding modules.

The apex locating function of Root ZX3 device is used for root canal measurement and working length determination.

The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty, gingivectomy, hemostasis, pulpotomy as an adjunct to root canal therapy, and excision of intraoral lesions. It is also used for the ablation of pulp, dental filling material (e.g. gutta-percha) and tissue in/around root canals as an adjunct to root canal therapy, after determining the tip position of the active electrode by apex location.

The Root ZX3 device (also referred to by its model number RZX3) is a battery-driven apex locator with an optional dental electrosurgical unit, used in the oral cavity during dental procedures. This device has two modules: the main module is an apex locator module and the other is an electrosurgical module (high frequency [HF] module). The apex locator module is the basic module to which dental electrosurgical functions can be added by connecting the HF module.

The provided text describes the 510(k) summary for the Root ZX3 dental device, which includes an apex locating function and an optional electrosurgical function. The document details the device's characteristics, intended use, and substantial equivalence to predicate devices, supported by non-clinical testing.

However, the provided text does not contain any information about specific acceptance criteria for a study showing device performance, or any detailed study results proving the device meets acceptance criteria. It states "No clinical tests were performed for the Root ZX3 device" and that "A performance test was conducted to confirm that Root ZX3 can locate the apex using the method that is substantially equivalent to the reference predicate devices. The high-frequency performance of this device was substantially equally to that of predicate devices, as shown in Table 2 (Comparison chart)."

The document focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to various safety and performance standards. It does not present a formal study with defined acceptance criteria and corresponding performance metrics for the Root ZX3 in the way a clinical or standalone performance study for an AI/CADe device would.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided text, as the necessary information (specific performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not present. Based on the provided information, the device's performance was evaluated through non-clinical testing and comparison to predicate devices to establish substantial equivalence.

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