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The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.

The X-Guide® Surgical Navigation Systemis an electro-optical device designed to aid dental surgical providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data.

The system provides the surgeon with a three-dimensional real time video visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y,Z, Pitch, Yaw,andRoll) and anaccuracy (RMS) of < 1 mm. Thishelps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is video based, the surgeon is still working in the freehand mode, meaning he/she is always in control of the surgery.

The implant process occurs in two stages. Stage 1 is the surgical implantation procedure. The dental surgeon plans the surgical procedure in the Implant Planning Software, XOS®. A virtual implant is aligned to the desired location in the CT scan. allowing the dental surgeon to avoid interfering with critical anatomical structures during implant has been optimally positioned, the plan is transferred to the X-Guide® Surgical Navigation System in preparation for implant surgery.

In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the pre-operative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient.

The relative motion of the dental handpiece and the patient an the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and drientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment.

This document primarily describes the substantial equivalence of the X-Guide Surgical Navigation System to a predicate device, focusing on changes made to patient registration methods. While it outlines various non-clinical performance tests, it does not provide a detailed study proving the device meets specific acceptance criteria in the format requested for an AI/ML device.

Specifically, the document lacks the following critical information for describing an AI/ML device's acceptance criteria and a study proving it:

• No mention of an AI/ML component: The device is described as an "electro-optical device" providing "accurate surgical tool placement and guidance" and "three-dimensional real time video visual aid." There's no indication of machine learning, AI-driven decision-making, or any algorithms that learn from data. The "software" mentioned is for planning and navigation, characteristic of traditional surgical navigation systems.
• No explicitly stated acceptance criteria for algorithmic performance: The performance tests focus on system accuracy (RMS < 1mm), calibrated device accuracy, and successful sterilization/biocompatibility, which are typical for non-AI medical devices.
• No "study" in the sense of an AI/ML performance study with a test set: The "performance testing" section describes basic engineering verification like accuracy, calibration, and simulated use, not a study evaluating an algorithm's performance on a dataset against ground truth.
• No data provenance, sample sizes, expert involvement, or ground truth details for an AI/ML test set.
• No MRMC study information.
• No standalone (algorithm only) performance information.
• No training set details.

Therefore, I cannot fulfill the request as the provided text does not describe an AI/ML device or a study proving its performance against acceptance criteria in the requested format for such devices. The performance data provided is for a traditional surgical navigation system.

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