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Surgic Pro+ / Surgic Pro
The Surgic Pro+ / Surgic Pro is intended for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth.

SG20/ X-SG20L
This medical device is for oral surgery and dental implant operation.
This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical drills to cut the maxilla / mandible during oral surgery and dental implant.

The Surgic Pro+ / Surgic Pro consists of the Control Unit, the Foot Control, Micromotor, Handpiece, and accessories for use with specific Motors. Components and accessories are included with each series set in accordance to the client's specific needs and requirements. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Control Unit is available without data storage capability or USB REC Key and USB flash drive socket for the Surgic Pro and with data storage capability and USB REC Key and USB flash drive socket for the Surgic Pro+ . The Surgic Pro+ has the same features as Surgic Pro with the addition of the USB data storage system.

The Handpieces included within this submission are intended for use in oral surgery and dental implant operation. This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical burs or surgical drills to cut the maxilla / mandible during oral surgery and dental implant. Available Handpieces include Optic Ti-Max X-SG20L and Non-Optic S- Max SG20. Optic and non-optic contra angle Handpieces are available to be used with the Motors to ensure torque accuracy. The Handpieces are designed for use with surgical burs that are diameter 2.35mm and conform to Type 1 of ISO 1797-1 (EN ISO 1797) standard.

Two models of the Micromotor with Motor cord are available, SGL70M Optic Motor and SG70M Non-Optic Motor. The SGL70M Optic Motor contains LED illumination of over 32,000 LUX.

The Foot Control allows operation of all functions within the preset parameters without touching the control panel to avoid accidental activation of the Micromotor outside the present limit. The Foot Controller provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction selection, and speed during operation.

This document is a 510(k) summary for the Nakanishi Inc. Surgic Pro+ / Surgic Pro, indicating it is a Class I medical device for dental implant and oral surgery.

Based on the provided text, there is no information about acceptance criteria, device performance data, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance related to AI or algorithm-driven medical device performance.

The document pertains to a mechanical dental device (handpiece, micromotor, control unit) and focuses on characteristics relevant to its mechanical function, electrical safety, sterilization, biocompatibility, and software validation in the context of its operation as a control system for mechanical functions, not a diagnostic or AI-powered device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device performance in the context of AI or algorithmic performance, as this information is not present in the provided text. The "software" mentioned in the document is for controlling device features (brightness, coolant flow, rotational direction, etc.) of the mechanical device, not for diagnostic or AI-driven tasks.

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