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The X-Guide® 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 and/or endodontic access procedures.
The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments.
The device is intended for use for partially edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.

The X-Guide® Surgical Navigation System is a cart mounted mobile system utilizing video technology to track position and movement of a surgical instrument (Dental Hand-Piece) during surgical procedures.
The X-Guide® Surgical Navigation System consists of a Mobile Cart, equipped with an LCD Monitor, Boom Arm, Navigation Assembly, Keyboard, Mouse and an Electronics Enclosure.
The Electronics Enclosure contains the system power supplies, data processing hardware, and electronics control circuitry for coordinating operation of the X-Guide® Surgical Navigation System.
A LCD Monitor, Keyboard, and Mouse serve as the main user interface for the surgeon. The Go-Button serves as an additional form of input by providing virtual buttons that a user can activate by touching them with the surgical instrument tip.
The Boom Arm allows the operator to manipulate the Navigation Assembly position for optimal distance and alignment to patterns located with the surgical region (Navi-Zone) for tracking purposes.
The Navigation Assembly contains two cameras oriented in a stereo configuration, along with blue lighting for illuminating the patterns and mitigating ambient lighting noise.
This electro-optical device is designed to improve dental surgical 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 surgical process occurs in two stages. Stage 1 is the pre-planning of the surgical procedure. The dental surgeon plans the surgical procedure in the X-Guide System Planning Software. A virtual implant or endodontic trajectory is aligned and oriented to the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during surgery. Once an implant or trajectory has been optimally positioned, the plan is transferred to the X-Guide Surgical Navigation System in preparation for surgery.
In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the preoperative plan.
As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracking patterns on the Handpiece 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 dental handpiece and 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 handpiece to be animated and depicted 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 manewer the dental handpiece into precise alignment.
During execution of the surgical procedure, the X-Guide® Surgical Navigation System correlates between the surgical plan and the surgeon's actual performance. If significant deviations in navigation between the plan and the system performance occur, the system will alert the user.

The provided text describes the X-Guide Surgical Navigation System, which includes a new feature: Automatic Image Processing (AIP) software integration (IconiX) using machine learning. This software is designed to segment and identify anatomical structures in maxillofacial CT scans and IntraOral Scans (IOS).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, pass/fail format with reported performance for EACH of the new ML-driven features. Instead, it states that "software verification and validation testing were conducted and documented" and that the "combined testing and analysis of results provides assurance that the device performs as intended."

However, the "Technology Performance Characteristics" table (pages 12-14) implicitly presents several performance characteristics that would have acceptance criteria for the base device, which are maintained. For the new ML features, the validation tests described aim to demonstrate "correct segmentations and visualizations," "automatically create a pan curve," "register (superimpose) the IOS over the CT," and "generate the X-Guide SurfiX."

Given the information, a table focusing on the new ML features would look like this:

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

The 510(k) summary does not explicitly state the sample size used for the test set. It mentions "varied CT data" for training (page 5) but does not provide specifics for the validation/test set.

Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for the test set is not specified in the provided document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions that users can "view and confirm the correctness and completeness of [ML] results and, if desired, replace or augment them with conventional tools/methods" (page 5), implying a human expert review process is part of the clinical workflow, but this does not detail how ground truth for the test set was established for regulatory validation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document explicitly states: "No clinical studies were performed for the submission of this 510(k)." (page 19) Therefore, no MRMC study was conducted, and no effect size regarding human reader improvement with AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study

The summary describes "Machine Learning Outputs Validation" and "Machine Learning Software Verification" (page 20).

• Machine Learning Outputs Validation: "This validation test demonstrates that the machine learning software outputs correct segmentations and visualizations for the expected patient population." This suggests an assessment of the algorithm's performance in generating segmentations in a standalone context (i.e., whether the outputs themselves were correct compared to ground truth).
• Machine Learning Software Verification: "This verification test demonstrates that the machine learning software meets specifications and requirements when integrated with the X-Guide System software..." This part focuses on the integrated performance.

While the details of the "Machine Learning Outputs Validation" are not provided, its description implies a standalone assessment of the ML algorithm's output accuracy against some form of ground truth.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for validating the machine learning outputs (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

The document mentions that the machine learning software is "trained on varied CT data" (page 5) but does not specify the sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established.

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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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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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