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510(k) Data Aggregation
(454 days)
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partially or fully edentulous jaws.
Navident is an image-guided dental navigational system intended to assist with preoperative planning and real-time positioning of drilling tools during implantation surgery. In particular, Navident provides visual, real-time feedback on the location of the working tip of a dental handpiece. It shows the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image. Navident is comprised of the following parts: The main system is comprised of a cart that carries a stereoscopic video camera and a laptop with pre-installed proprietary software. The Navident system also includes several types of accessories: Jaw motion Tracking Accessories, Dental Handpiece Tracking Accessories, Registration accessories, Calibrator. Navident's four core functions are: Model, Plan, Register, Guide.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:
Device: Navident
Product Code: PLV
Regulation Number: 21 CFR 872.4120
Regulation Name: Bone Cutting Instrument And Accessories
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the performance data of the device rather than explicit "acceptance criteria" presented as pass/fail thresholds against specific metrics, except for the accuracy at the drill tip. Instead, it describes various validation and testing activities that collectively demonstrate the device's acceptable performance.
| Category | Acceptance Criteria / Standard (Implicit or Explicit) | Reported Device Performance / Study Finding |
|---|---|---|
| Reprocessing | Per AAMI TIR 30: 2011(R) 2016 for cleaning (Proteins < 6.4 µg/cm2, Hemoglobin < 2.2 µg/cm2). Per ISO 17665-1:2006 (R) 2013 for sterilization (acceptable sterility assurance level). | Cleaning: Validation demonstrated that the cleaning process included in Navident's labeling can reduce the organic soil load to an acceptable level (meeting the specified protein and hemoglobin thresholds). Sterilization: Validation confirmed components withstand steam sterilization and achieve acceptable sterility using recommended protocols. |
| Biocompatibility | Per ISO 10993-1 series or justified non-performance. | Patient-contacting components considered tissue contacting for < 24 hours. Tested per ISO 10993-1 or justification provided per FDA Guidance. |
| Software | Per FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern). | Software documentation submitted according to the guidance. |
| Electrical Safety | Per IEC 60601-1:2005 Edition 3.1 & ANSI/AAMI ES60601-1:2005 / 2012 & C1:2009/ 2012 & A2:2010/ 2012. | Compliance with these standards for product safety. |
| Electromagnetic Compatibility (EMC) | Per IEC 60601-1-2:2014 Edition 4.0. | Compliance with this standard for EMC. |
| Wireless Technology | Per FDA Guidance "Radio Frequency Wireless Technology in Medical Devices". | Evaluation assessment conducted. |
| System Accuracy Test (Bench) | Explicit: Accuracy at the drill tip ≤1.0mm. Stability and repeatability of patient reference tag coupling to jaw. | In all instances (System accuracy test, stability of Jaw Tracker S, C, B, U attachments), the Navident device functioned as intended and the results observed were as expected. The "Accuracy at the drill tip" is explicitly stated as "≤1.0mm" for the proposed Navident, matching the predicate device. Observed performance of new Trace Registration Method: Mean deviation for 136 implants: 0.67 mm (entry), 0.9 mm (apex), 0.55 mm (depth), 2.50° (angular). These values are all below the 1.0mm limit for positional accuracy and represent successful performance for the angular deviation. |
| Human Factors/Usability | Meet identified user specifications; no significant use errors, close calls, or operational difficulties. | Summative evaluation demonstrated that the Navident system satisfies identified user specifications. Minor findings were thoroughly analyzed and design improvements made. |
| Clinical Literature (Trace Registration Method) | Demonstrate acceptable accuracy for the new registration method, comparable to or better than existing methods. | Study 1: 136 implants in 59 partially edentulous patients. Mean deviation: 0.67 mm (entry point), 0.9 mm (apex), 0.55 mm (depth), 2.50° (angular deviation). 95th percentile values for trace registration (5-6 teeth) were favorable compared to fiducial marker-based registration (predicate device's method). Study 2: (Pterygoid implants) 31 dynamic navigation cases vs. 32 freehand surgery cases. Mean deviations for dynamic navigation via trace registration: 0.66 mm (coronal), 1.13 mm (apical), 0.67 mm (depth), 2.64° (angular). This was more accurate than freehand surgery. |
2. Sample Sizes and Data Provenance
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Test Set (Clinical Data from Literature):
- Study 1 (Trace Registration Accuracy): 136 implants placed in 59 partially edentulous patients.
- Study 2 (Pterygoid Implants): 63 pterygoid implants in 39 partially edentulous patients (31 with dynamic navigation/trace registration, 32 with freehand surgery).
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Data Provenance: Clinical studies were conducted outside of the US. The document states that "patient populations, user profiles, use environment, and clinical practices are considered equivalent and applicable to the US population." The studies are retrospective, as they are "published scientific literature" that was collected and analyzed.
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Human Factors/Usability Study: 15 representative users.
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Bench Testing: Sample sizes are not explicitly stated for individual bench tests (reprocessing, electrical safety, EMC, full system accuracy bench testing, stability/repeatability of attachments), but it mentions "representative devices" and "representative master devices."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The clinical studies referenced are "published scientific literature" and involve "qualified dental surgeon(s)" performing the procedures. The ground truth for the clinical accuracy studies (Study 1 & 2) appears to be derived from actual implant placement compared to the pre-planned position (likely measured from post-operative imaging).
- Number of Experts: Not explicitly stated as "number of experts for ground truth establishment." The studies were performed by treating surgeons. Study 2 mentions "the same surgeon" for comparative data, implying single-surgeon data collection for parts of the comparison.
- Qualifications of Experts: "Qualified dental surgeon(s)." One of the authors in the referenced papers (Stefanelli LV, Mandelaris GA) are typically oral and maxillofacial surgeons or periodontists who are experts in implant surgery.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is described for the ground truth of the clinical studies. The accuracy metrics appear to be derived from quantitative measurements comparing planned vs. actual outcomes, likely without a separate expert adjudication panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not explicitly performed in the context of comparing human readers with and without AI assistance, as Navident is a surgical navigation system, not an AI-assisted diagnostic imaging device for human reading. The "comparison" is between different surgical techniques (dynamic navigation with trace registration vs. freehand surgery, or dynamic navigation with new trace registration vs. old fiducial registration) or system accuracy benchmarks, not human interpretation of images. However, the studies demonstrate the clinical effectiveness of the device-assisted procedure.
- Effect Size for AI vs. Without AI Assistance:
- Study 1 (Trace Registration vs. Fiducial-based): The 95th percentile values for the trace registration method were "favorable" compared to the fiducial-based registration method (cleared predicate). This implies an improvement, but specific effect sizes are not quantified here beyond the descriptive "favorable." This is a comparison of system performance, not human performance.
- Study 2 (Dynamic Navigation with Trace Registration vs. Freehand Surgery): Dynamic navigation was "more accurate." The mean deviations for dynamic navigation were significantly lower across all metrics (e.g., 0.66 mm coronal vs. 1.54 mm for freehand; 2.64° angular vs. 12.49° for freehand). This provides a clear quantitative effect size for the improvement in surgical accuracy when using the device compared to freehand.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The "Full system accuracy bench testing" and the clinical accuracy studies (comparing planned vs. actual implant positions) inherently represent the performance of the algorithm and system, as they quantify the accuracy of the guidance provided by the device. While a human surgeon provides the input and executes the drilling, the accuracy metrics are a direct measure of the system's ability to guide to the planned position. The "Accuracy at the drill tip: ≤1.0mm" is a standalone performance metric.
7. Type of Ground Truth Used
- Clinical Studies: Ground truth for implant accuracy was based on comparison of the pre-planned position (from CT scan) with the actual post-operative implant position (derived from post-operative imaging). This is a form of outcomes data or objective measurement of surgical execution.
- Bench Testing: Ground truth for system accuracy was established through controlled measurements conducted on test setups designed to measure the mapping accuracy and stability.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its size. This is a surgical navigation system, not typically a machine learning or AI model trained on a large imaging dataset in the conventional sense. The "training" for the device's development would be more akin to algorithm development and calibration rather than data-driven machine learning, although some components might use statistical models or optimizations. The clinical literature cited pertains to validation of the device's performance, not training data for an AI.
9. How the Ground Truth for the Training Set was Established
Given that a specific "training set" for an AI algorithm is not mentioned, the method for establishing its ground truth is also not described. The device's core functionality relies on stereoscopic optical tracking and registration algorithms, whose "ground truth" and performance are verified through precise engineering and bench testing rather than large-scale data labelling for AI training.
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(243 days)
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.
| Acceptance Criterion (Implicitly Carried Over from Predicate Device) | Reported Device Performance (for new indication based on comparative studies) |
|---|---|
| Overall System Accuracy (RMS) < 1mm | X-Guide Dynamic Navigation resulted in better linear and angular deviation compared to freehand for endodontic access procedures (Root Canal Access and Apico Access). |
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:
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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.)
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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:
- Dynamically navigated surgery (with X-Guide System assistance)
- 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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