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510(k) Data Aggregation
(217 days)
X-Nav Technologies, LLC
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:
| Acceptance Criteria (Implied from Validation Test Descriptions) | Reported Device Performance (Implied from Submission Outcome) |
|---|---|
| Machine Learning Outputs Validation: | Met: The device received 510(k) clearance, implying that the FDA found sufficient evidence that the ML software outputs "correct segmentations and visualizations for the expected patient population." |
| - Correct segmentation and identification of anatomical structures in CT (Teeth, Maxilla bone, Mandible bone, Maxillary Sinuses, Mandibular Nerve Canal) | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) |
| - Correct segmentation and identification of anatomical structures in IOS (Teeth, Gingiva) | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) |
| Machine Learning Software Verification: | Met: The device received 510(k) clearance, implying that the FDA found sufficient evidence that the ML software "meets specifications and requirements when integrated with the X-Guide System software." |
| - Ability to automatically create a pan curve to fit the arch (minimum of two teeth per sextant required) | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) The new software provides automatic pan curve creation where the predicate required manual marking. This functionality is considered similar to reference devices that also auto-generate pan curves. |
| - Ability to register (superimpose) the IOS over the CT automatically | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) The new software provides automatic IOS to CT registration where the predicate required manual point-matching. This functionality is considered similar to a reference device that also combines surface models from intraoral and CBCT scans. |
| - Ability to generate the X-Guide SurfiX from segmented teeth and bone for X-Mark Registration or Refinement | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) The new software provides automatic Surface Definition (SurfiX) where the predicate required manual selection. |
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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(243 days)
X-Nav Technologies, LLC
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-Nav Technologies,LLC.
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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(137 days)
X-Nav Technologies, LLC
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
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
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(251 days)
X-Nav Technologies, LLC
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
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.
| Acceptance Criteria (Inferred from Predicate and claims) | Reported Device Performance |
|---|---|
| Overall System Accuracy (RMS) | ** |
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