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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 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 System is an electro-ontical device designed to aid dental procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data.

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

The implant process occurs in two stages is the preplanning of 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 surgery. Once an implant has been optimally positioned, the X-Guide® Surgical Navigation System in preparation for implant surgery.

In Stage 2 the system provides accurate quidance 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 tracking patterns on the Hand Piece Tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processed by data processing hardware to precisely and continuously track the motion of the surgically-relevant portion of the patient.

The relative motion of the dental handpiece and the patient anatomy, captured by the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpieced in precise location and orientation 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.

Several patient-specific calibrations underpin the quidance system. Hand Piece calibration is performed to determine the geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument.

The provided document is a 510(k) premarket notification for the X-Guide® Surgical Navigation System. It primarily focuses on demonstrating substantial equivalence to a predicate device (IGI-System™ by DENX Advanced Dental Systems Ltd. K023424) rather than presenting a detailed clinical study report with specific acceptance criteria and a comprehensive study design for device performance.

Therefore, many of the requested details about acceptance criteria, study design for proving performance, and expert involvement are not explicitly stated in the provided text as one would find in a dedicated clinical study report. The document describes aspects of verification and validation, including software testing and general clinical testing for accuracy and usability, but not a full-fledged MRMC or standalone performance study as might be conducted for an AI-driven diagnostic device.

Here's an attempt to extract and infer the information based on the provided text, while noting the limitations:

1. Table of Acceptance Criteria & Reported Device Performance:

The primary performance criterion mentioned consistently is navigation accuracy.

2. Sample Size Used for the Test Set and Data Provenance:

• Clinical Testing Sample Size: "Over 150 patients participated in the study."
• Data Provenance: The document states that "Clinical testing was conducted by Board Certified Oral Surgeons and testing was conducted at their facilities." This implies the data is likely prospective from clinical use in the US (given the FDA submission).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not explicitly stated. The testing was conducted by "Board Certified Oral Surgeons."
• Qualifications of Experts: "Board Certified Oral Surgeons." The document does not specify their years of experience but board certification implies a high level of expertise in their field.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified or described. The document mentions that the system provides "continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment" and "If significant deviation between the plan and the system performance occur, the system will alert the user." This suggests real-time feedback and alerts as part of the system's operation, but not a separate adjudication process for a test set in the traditional sense of a diagnostic study.

5. MRMC Comparative Effectiveness Study:

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in the provided text. The device is a surgical navigation system, providing real-time guidance, not primarily a diagnostic imaging interpretation tool typically assessed with MRMC studies. The document states it is "a supporting additional information to the decision-making process during the surgical procedure. It is by no means intended to replace the surgeon's judgment."

6. Standalone Performance (Algorithm Only):

• Standalone Performance: Not explicitly detailed as a separate study. The "Overall System Accuracy (RMS) of < 1 mm" is a performance metric, likely derived from technical and potentially simulated clinical testing, but the document doesn't isolate the "algorithm only" performance from the integrated system functioning with human interaction. The device is fundamentally a navigation system with a human in the loop.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for surgical navigation systems like this is typically established by comparing the navigated instrument's actual position and orientation to the pre-planned CT-based surgical plan. The root mean square (RMS) accuracy of < 1 mm is a measure against this planned (and presumably verified) target. The text mentions "CT scan data" and "virtual implant is aligned to the desired location in the CT scan." This suggests the surgical plan derived from CT data serves as the target or "ground truth" for the navigation's accuracy validation.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable or not specified. This document describes a medical device, not an AI model that undergoes a machine learning training phase with a dedicated dataset. The software undergoes "Software Verification and Validation Testing," which is a standard engineering process, not a machine learning training process.

9. How Ground Truth for Training Set Was Established:

• Ground Truth for Training Set: Not applicable, as there's no mention of a machine learning training set or associated ground truth establishment for such a purpose. The accuracy and performance claims are based on engineering validation and usability/clinical observation.

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