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510(k) Data Aggregation
(217 days)
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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:
| 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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(87 days)
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Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.
Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. Yomi Robotic System is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
The Yomi Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.
The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Clamped Chairside Patient Splint (C-CPS) or YomiLink Bone (YLB), the Tracker End Effector (TEE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).
The subject of this submission is to modify the design and reprocessing method for the Tracker End Effector (TEE) of the Yomi Robotic System. All other aspects of the Yomi Robotic System remain unchanged from prior clearances.
Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested structure:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| System Accuracy | Total System Accuracy Verification | Performed (demonstrates substantially equivalent performance) |
| Kinematic Performance | Kinematic Mount Repeatability Verification | Performed (demonstrates substantially equivalent performance) |
| Drill Jig Accuracy | Drill Jig Accuracy Verification | Performed (demonstrates substantially equivalent performance) |
| Reprocessing Effectiveness | High-Level Disinfection Validation (per AAMI TIR12 and FDA Guidance) | Performed (demonstrates disinfection provides adequate microbicidal reprocessing) |
| Reprocessing User Experience | Usability validation testing for modified reprocessing instructions | Performed (included dental clinician users evaluating critical tasks and providing feedback) |
| Material Properties | Verification testing for modified material (Aluminum 7075 vs 6061) | Performed (demonstrates no impact on substantial equivalence) |
| Mating Component Design | Verification testing for V-coupled design vs. fiducial pins/spheres | Performed (demonstrates no impact on substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the performance tests (Total System Accuracy, Kinematic Repeatability, Drill Jig Accuracy, Disinfection Validation, Material Testing, Mating Component Design Verification). It only indicates that these tests were "fully executed."
For the Usability Validation Testing for reprocessing instructions, the document mentions "dental clinician users," but the specific number (sample size) is not provided. The data provenance is implied to be through direct observation and feedback from these users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for the performance tests. These tests appear to be engineering verification and validation tests rather than clinical studies requiring expert ground truth in the traditional sense.
For the Usability Validation Testing, it states that "dental clinician users" were involved, but their specific qualifications (e.g., years of experience, specialty) or the number of such users are not detailed.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1) for any of the described tests. The tests appear to be objective verification and validation tests where outcomes are measured against predefined technical specifications or industry standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on performance testing related to design modifications and reprocessing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The Yomi Robotic System is described as a "computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery." This implies a human-in-the-loop system. The document does not describe any standalone performance studies where the algorithm or robotic system operates without human interaction or oversight for clinical decision-making or execution. The "Total System Accuracy Verification" would likely assess the machine's standalone accuracy within the system's design, but not as a replacement for human performance.
7. Type of Ground Truth Used
For the performance tests (accuracy, repeatability, drill jig accuracy, material, design), the ground truth would be based on engineering specifications, metrology standards, and validated test methods. For the disinfection validation, the ground truth is established by microbiological testing against industry standards (AAMI TIR12 and FDA Guidance). For the usability testing, the ground truth is likely based on user feedback and successful completion of critical tasks as defined by the usability protocol. No explicit mention of clinical outcomes data or pathology as ground truth is made, which aligns with the focus on design modifications and reprocessing rather than a new clinical application.
8. Sample Size for the Training Set
The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense. The device is a robotic system providing navigational guidance. If any internal models or algorithms are used, the training data for those are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (or implied for AI/ML purposes), this information is not provided.
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(115 days)
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Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous adult patients who qualify for dental implants.
When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.
In terms of FDA regulations, the Yomi Robotic System is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). In terms of previously FDAcleared indications for use (K210711), the Yomi Robotic System is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
The Yomi System allows the user to plan the surgery virtually in Yomi Plan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDAcleared third party powered bone cutting instrument.
The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).
The subject of this submission is introducing a feature to allow the system to be used for planning and performing guided bone reduction (also known as alveoplasty). The bone reduction feature is intended for use during dental implant procedures to flatten the surface of the bone intended for dental implant placement. The device is used with compatible bone cutting tool secured to the guidance arm for the bone reduction. The bone reduction feature is intended to be performed on full arch or partially edentulous patients. During preoperative planning, the surgeon identifies the area of the bone to be reduced. Real-time visualization of the bone reduction is visualized on the graphic user interface. The guidance arm constrains the movement of the cutting tool to the planned location, boundaries, and depth. After the bone reduction, the implant procedure continues with the Yomi Robotic System.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device is "substantially equivalent" to predicate devices, but it does not explicitly list specific acceptance criteria with numerical targets or thresholds. Instead, it focuses on demonstrating equivalence through various performance tests and comparisons.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Equivalence to Predicate Device: The device should perform comparably to legally marketed predicate devices for its intended use. (Implied acceptance criteria for 510(k) clearance) | Substantially equivalent to Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711) and reference to Mako Partial Knee Application (K142530). No fundamental changes to technology. |
| Safe and Effective Performance for Bone Reduction Feature: The new bone reduction feature should function as intended without introducing new safety or effectiveness concerns. (Implied) | Verification testing of the new handpiece and bur. Verification of bone reduction planning, visualization, and performance. Bone reduction accuracy verification. Full system cadaver validation. Human Factors Validation for Bone Reduction. Software End User Validation of Bone Reduction. |
| Software Functionality: The software user interface should function as intended. (Performance Testing, Section VII) | Software verification testing fully executed according to ANSI AAMI ISO 14971:2019, ANSI AAMI IEC 62304:2006/A1:2016, and FDA Guidance for Premarket Submissions and Software Validation. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The document refers to "Full system cadaver validation" for both the primary predicate and the subject device (section V and Table 1). It also mentions "Human Factors Validation for Bone Reduction" and "Software End User Validation of Bone Reduction."
- Sample Size: The exact sample size (number of cadavers, number of users for human factors/software validation) is not specified in the provided text.
- Data Provenance: The cadaver validation implies use of human anatomical specimens, and "Human Factors Validation" suggests involving human users. The origin (e.g., country) of these cadavers or participants is not specified. The studies appear to be prospective in nature, as they involve testing the new feature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the text. The document mentions "surgeon plans" in the workflow description, implying clinical expertise, but it does not detail the involvement of experts in establishing ground truth for testing or validation purposes.
4. Adjudication Method for the Test Set:
This information is not provided in the text. There is no mention of a formal adjudication process (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating test results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not explicitly mentioned in the provided text. There is no information about human readers improving with or without AI assistance. The focus is on the robotic system's performance and substantial equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document describes the Yomi Robotic System as a "computerized robotic navigational system intended to provide assistance in both the planning... and the surgical (intra-operative) phases." It explicitly states that the system "provides robotic navigational guidance of the surgical instruments" and "provides physical, visual, and audible feedback to the surgeon." This strongly indicates that the device is designed for human-in-the-loop operation, and therefore, a standalone (algorithm only) performance study would likely not be the primary focus or relevant to its intended use. The performance testing focuses on the system's accuracy and functionality within this assisted context.
7. Type of Ground Truth Used:
The document mentions "Bone reduction accuracy verification" and "Full system cadaver validation." This suggests that the ground truth for performance was established based on:
- Physical measurements/direct observation on anatomical specimens (cadavers): For verifying the accuracy of bone reduction performed by the robot.
- Planned surgical boundaries: The system guides based on a pre-operative plan, so the ground truth would be the accurately executed plan.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. This is typical for 510(k) submissions focusing on substantial equivalence for robotic-assisted surgical devices, which often rely on established engineering principles, verification, and validation rather than large-scale machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, this information is not applicable/provided in the text.
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(243 days)
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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)
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