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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 circuity 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 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 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 implant process occurs in two stage 1 is the pre-planning of the surgical implantation procedure. The dental surgeon plans the surgical procedure in the X-Guide System Planning Software. A virtual implant is aligned 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 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.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Context: The FDA 510(k) submission (K211701) for the X-Guide® Surgical Navigation System is seeking to expand its indications for use to include endodontic access procedures, in addition to its existing clearance for dental implantation procedures. The core argument is that endodontic access procedures are technologically similar to drilling pilot holes for implants, and existing system performance (accuracy) is sufficient.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format for this specific submission's expanded indication. Instead, it relies on the existing performance characteristics of the predicate device (X-Guide® Surgical Navigation System, K192579) and demonstrates through comparative studies that this performance is better than freehand for the new indication.

The key performance characteristic cited is Overall System Accuracy (RMS) < 1mm. This is implicitly the acceptance criterion carried over from the predicate device and is expected to hold for the new indication.

Note: The document explicitly states "No performance standards have been established for Dental Stereotaxic Instruments under Section 514 of the Food, Drug and Cosmetic Act." This usually means the FDA relies on comparative performance and substantial equivalence to a predicate device.

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

• Study 1: Root Canal Access

  • Sample Size: 40 total human roots
  • Data Provenance: Cadaver study using 2 cadaver heads. (Implies retrospective use of cadaveric material, but the study itself is prospective in its execution.)

• Study 2: Apico Access

  • Sample Size: 60 total human single-rooted teeth
  • Data Provenance: Cadaver study using teeth mounted in 2 dry cadaver jaws. (Implies retrospective use of cadaveric material, but the study itself is prospective in its execution.)

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

The document does not specify the number of experts or their qualifications for establishing ground truth. The studies relied on a "presurgical CBCT plan" that was compared to "navigated or freehanded trajectories in the post-operative CBCT." This implies that the ground truth for planning was based on the CBCT image and the surgical plan created by a user of the X-Guide system, without explicit mention of external experts for adjudication or ground truth establishment beyond the system's inherent planning capabilities. The studies were likely performed by endodontists, as the description states "endodontists can effectively perform endodontic access procedures with the X-Guide."

4. Adjudication Method for the Test Set:

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparison was made between the "presurgical CBCT plan" and the "post-operative CBCT" (drilled trajectory). This suggests a direct comparison of imaging data, likely involving measurement software, rather than a consensus-based expert review.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not an MRMC comparative effectiveness study in the traditional sense of evaluating AI assistance on human reader performance. This device is a surgical navigation system, not an AI diagnostic tool that assists human readers.

The studies compared two surgical methods:

1. Dynamically navigated surgery (with X-Guide System assistance)
2. Freehand surgery (without X-Guide System assistance)

The effect size is described qualitatively:

• "The linear deviation and angular deviation in dynamically navigated roots were found to be better than freehand."

No specific quantitative effect size (e.g., percentage improvement in accuracy, reduction in deviations) is provided in the summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device requires human-in-the-loop performance. It is a "computerized navigational system intended to provide assistance" to a surgeon. The studies directly evaluate the performance with a surgeon using the system versus without. Therefore, a standalone (algorithm only) performance assessment would not be relevant or conducted for this type of device.

7. The type of ground truth used:

The ground truth used for comparison was the presurgical CBCT plan for the intended trajectory. This plan was compared against the post-operative CBCT showing the actual drilled trajectory.

8. The sample size for the training set:

The document does not mention a training set for the device itself in the context of these studies. The X-Guide System is a navigation system that was already developed and "currently cleared." This submission is about expanding its indications for use based on its existing, proven technology. The studies assess the application of the already-trained system, not the training of a new AI model for this indication.

9. How the ground truth for the training set was established:

As no training set is mentioned for this specific submission, the method for establishing its ground truth is not provided. The X-Guide System's initial development and clearance (K192579, K150222, K200662) would have involved its own validation, but that information is beyond the scope of this particular 510(k) summary.

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