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510(k) Data Aggregation
(243 days)
X-Guide**®** Surgical Navigation System
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)
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(69 days)
X-Guide**®** Surgical Navigation System
The X-Guide® 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 and edentulous adult and geriatric patients who need dental implants as part of their treatment plan.
The X-Guide® Surgical Navigation System is an electro-optical dental implantation procedures by providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data.
The X-Guide® Surgical Navigation System is currently cleared (K150222) with Bone Screws which are intended to affix an Edentulous Clin to an edentulous patients anatomy. The Edentulous clip is necessary to attach tracking patterns to facilitate the navigation and tracking process, and is calibrated to the patient anatomy and CT.
As an alternative, the proposed EDX Bone Screws and EDX Nut may be used to secure tracking patterns to edentulous patient anatomy.
The proposed EDX Bone Screws are a titanium screws which are tapered and vary in diameters of 2.7 mm and 3.2 mm wth thread lengths of 7mm and stud lengths of 4 mm, and 16 mm. In addition to the dimensional design changes, the screws have been modified with an M5 threading to accept the EDX Nut. The addition of M5 the Bone Screw is necessary to secure the tracking patterns to the patient.
The 2.7 mm diameter EDX Bone Screws are typically placed to secure the EDX Tracker Arm. Should the bone be too soft resulting in a loose Bone Screw, a large diameter "rescue" EDX Bone Screw (3.2 mm diameter) can be placed.
All of the EDX Bone Screws and EDX Bone Nuts are manufactured using a Ti6AL4V (Grade 5) alloy per ASTM F136 and adhere to the requirements of ASTM F543.
The EDX Bone Screws are intended to be removed from the conclusion of the surgical implant procedure. The EDX Bone Screws are single use devices, sold in a non-sterile state and intended to be sterilized by the end user prior to use.
The body of the proposed EDX Tracker Arms a stanless steel, which is a harder material providing more stability / rigidity in the Tracker Arm. A passivation coating is added to prevent oxidation of the during steam sterilization.
The EDX Tracker Arms include a spike intended to added stability in EDX Tracker Arm registration.
The body of the proposed EDX Tracker Arms are contoured in a variety of geometric shapes intended to minimize interferences with patient soft tissue by positioning on the Mandible and Maxilla in the posterior positions of the oral cavity.
The EDX Tracker Arms are distributed in a non-sterile state, and intended to be sterilized by the end user prior to use.
This is an FDA 510(k) Premarket Notification for the X-Guide® Surgical Navigation System, specifically addressing new components (EDX Bone Screws, EDX Nut, and EDX Tracker Arms). The document details the device description, comparison to predicate and reference devices, and non-clinical performance testing.
Here's the breakdown of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance numbers for the new components in terms of clinical accuracy or effectiveness. Instead, the "Performance Testing - Non-Clinical" section describes various tests performed and their conclusions, primarily focusing on demonstrating equivalence to the predicate device or adherence to existing standards.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Mechanical Properties | The predicate device's bone screws were tested per ASTM E543-17. The new EDX Bone Screws should be substantially equivalent in mechanical properties. | A review of test results and comparison demonstrated that the EDX Bone Screws are substantially equivalent to the predicate device Bone Screws. |
| Additional mechanical testing was conducted to assess comparative deflection and stability of the EDX assembly under load conditions (specific results not detailed). | ||
| Biocompatibility | Per FDA Guidance document 1811, "Use of International Standard ISO 10993-1," biocompatibility testing is not necessary if the material, process, and tissue contact are comparable to a legally marketed predicate device, and manufacturing does not adversely impact biocompatibility. Otherwise, cytotoxicity, sensitization, and irritation testing are required. | The EDX Bone Screws, EDX Bone Screw Nut, and EDX Tracker Arms were deemed equivalent in material, process, and tissue contact to the predicate device. Therefore, biocompatibility results from the predicate device (K150222) were used to demonstrate compliance. |
| Sterilization | The new components (EDX Bone Screws) should meet a sterility assurance level (SAL) of ≤10-6 using the biological indicator (BI) overkill method. Cleaning and sterilization validation per ISO 17665-1 and FDA Reprocessing Guidance Document. | The EDX Bone Screws are considered geometrically similar to the predicate system, which successfully met a SAL of ≤10-6. Cleaning and sterilization validation conducted per ISO 17665-1 and FDA Reprocessing Guidance Document were provided. |
| Effect on Navigation | The changes in the EDX components (bone screws, nut, tracker arms) should not raise new issues of substantial equivalence, implying that the navigational accuracy and performance of the X-Guide® system should remain consistent with the cleared predicate. | "(S)ubstantial equivalence between the predicate and the proposed EDX Bone Screw, EDX Tracker Arms, and EDX Bone Screw Nut has been demonstrated throughout this submission by performance and bench testing, comparison of intended clinical and similarity in materials." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each specific test mentioned (e.g., mechanical testing, sterilization validation). The document uses a comparative approach, relying on the substantial equivalence to previous tests or established standards.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or conducted by the manufacturer based on regulatory standards. The studies referred to are "performance and bench testing." The phrase "Additional mechanical testing was conducted on the subject device" suggests this was done for the current submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The provided document details non-clinical performance testing and a comparison to a predicate device for regulatory clearance. It does not describe a study involving human experts to establish ground truth for a test set in the context of diagnostic accuracy or clinical decision-making.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a test set requiring adjudication in the context of expert review or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this submission. The document explicitly states: "Clinical testing was not necessary for the substantial equivalence determination."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a surgical navigation system, which inherently involves a human (the surgeon) in the loop. The "performance and bench testing" described are non-clinical and focus on the physical components and their properties, not a standalone algorithmic performance in the absence of human interaction.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by:
- Established Standards: e.g., ASTM E543-17 for mechanical properties, ISO 10993-1 for biocompatibility, ISO 17665-1 for sterilization.
- Predicate Device Data: Performance characteristics of the previously cleared X-Guide® Surgical Navigation System (K150222) serve as a baseline for demonstrating substantial equivalence of the new components.
8. The Sample Size for the Training Set
Not applicable. This document is not describing an AI/algorithm where a "training set" would be used in the traditional sense. The X-Guide® system is a navigation system that uses CT scan data for preoperative planning and intra-operative guidance, not a machine learning model that requires a training set for its development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/algorithm described in this document.
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