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510(k) Data Aggregation
(126 days)
Yomi Robotic System
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 robotional 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 Robotic System 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. 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 the 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 Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.
The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. The YomiLink Arch allows for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch (YLA).
Following attachment of YomiLink Bone (YLB) to the patient, probing of the YLA is performed utilizing the YLA Probing Bit to transfer registration in the software from YLA to YLB and allow for tracking of the YLB throughout the remaining surgical procedure. The YLA Probing Bit is available in straight and contra-angle configurations corresponding to the handpiece to which they are attached.
All other aspects of the Yomi Robotic System remain unchanged from prior clearances.
This document describes the regulatory approval of the Neocis Yomi Robotic System with new accessories (YomiLink Arch and Probing Bit), indicating substantial equivalence to a previously cleared device. However, it does not provide explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for an AI device. Instead, it refers to performance testing conducted to ensure the device functions as intended.
Based on the provided text, here's an attempt to structure the information, acknowledging the limitations for a full AI acceptance criteria description:
1. Table of Acceptance Criteria and Reported Device Performance
As the document is a 510(k) summary for a robotic surgical system, not a purely AI diagnostic or prognostic device, the "acceptance criteria" are described in terms of verification and validation testing to ensure the added accessories and workflow maintain the system's intended function and safety. Specific numerical performance metrics for AI algorithms (like sensitivity or specificity) are not provided in this regulatory summary.
| Acceptance Criteria Category (as inferred from Performance Testing) | Reported Device Performance (as inferred from "Verification/Validation" statements) |
|---|---|
| Total System Accuracy Verification (with YLA workflow) | "fully executed to ensure that the subject device functions as intended" |
| Guided Splint Placement Verification (as part of YLA workflow) | "fully executed to ensure that the subject device functions as intended" |
| Probing and Registration Verification (of YLA) | "fully executed to ensure that the subject device functions as intended" |
| Deflection and Repeatability Verification (of YLA attachment) | "fully executed to ensure that the subject device functions as intended" |
| Proximity Warnings Verification (generated throughout YLA workflow) | "fully executed to ensure that the subject device functions as intended" |
| Typical Run Through Verification (of user application throughout YLA workflow) | "fully executed to ensure that the subject device functions as intended" |
| Human Factors Validation (of YLA design) | "fully executed to ensure that the subject device functions as intended" |
| Software End User Validation (YLA user application meets user requirements) | "fully executed to ensure that the subject device functions as intended" |
| Biocompatibility | Met per FDA Guidance Document for Use of Standard ISO 10993-1 |
| Validated Cleaning & Sterilization Instructions | Met per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1 and ISO 17665-2 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for individual tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described appears to be a series of engineering and usability validations rather than a clinical study with a patient-derived test set in the conventional sense of AI performance evaluation. The "test sets" would likely refer to engineering models, simulated environments, and potentially cadaveric or phantom models for accuracy and repeatability testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a robotic system, "ground truth" often involves highly precise measurement equipment and established engineering benchmarks rather than expert clinical consensus for image interpretation. For human factors validation, usability experts and clinicians would be involved, but specific numbers and qualifications are not listed here.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No MRMC study is mentioned. This type of study is typically performed for AI systems that assist human readers in diagnostic or screening tasks. The Yomi Robotic System is a surgical guidance system, and the "AI" component is more embedded in its navigation and planning software, not as a separate diagnostic reader.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The performance testing revolves around the integrated system, including the software and new accessories (YomiLink Arch and Probing Bit) as they interact within the existing Yomi Robotic System workflow. While core algorithm accuracy is verified, it's presented within the context of the overall system's function, not as a standalone AI diagnostic output. The YomiPlan software is for preplanning, and its output is to be used with the Yomi Robotic System, not as a standalone diagnostic.
7. The Type of Ground Truth Used
The ground truth for the device's accuracy and performance would be established through a combination of methods typical for robotic systems:
- Physical measurements: Using highly accurate metrology equipment to verify positioning, deflection, and repeatability against known physical standards.
- Engineering specifications: Comparing system performance against pre-defined engineering tolerances and design requirements.
- Simulation/Phantoms: Testing the system's ability to accurately navigate and execute plans on controlled phantom models.
- User requirements: For human factors and software end-user validation, the "ground truth" would be the successful completion of tasks by users in accordance with specified requirements and industry standards for usability.
Specific details about the type of ground truth for each test are not elaborated in this summary.
8. The Sample Size for the Training Set
The document does not mention the sample size for the training set. For a robotic navigational system like Yomi, "training" might refer to the development and refinement of algorithms for spatial recognition, registration, and robotic control. This process typically involves extensive internal validation and iterative development with various datasets (e.g., 3D models, CBCT scans) but does not necessarily align with the concept of a "training set" in the context of supervised machine learning for diagnostic tasks.
9. How the Ground Truth for the Training Set was Established
This information is not provided. Similar to point 7, the "ground truth" for developing such a system would be based on engineering principles, known anatomical landmarks, and precise spatial measurements to ensure accurate digital representations and their correlation with physical reality for robotic guidance.
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(87 days)
Yomi Robotic System
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)
Yomi Robotic System
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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(399 days)
Yomi Robotic System with YomiPlan Go
Yomi 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. 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.
The subject of this submission is YomiPlan Go, a feature of the Yomi Robotic System which enables the use of the system without the uploading of a preoperative CT scan. The dynamic planning feature in K202264 requires a pre-operative CT scan for use. This submission includes a new workflow called YomiPlan Go and provides instructions on how to use this feature without the need of uploading a CT scan to the Yomi system. This planning involves placing the robotic arm drill tip to the point where an osteotomy is to be performed i.e., the surgeon performs planning with their direct visualization of the anatomy and with the use of the robotic arm to select where the osteotomy is to be performed. YomiPlan Go gives surgeons the ability to perform an osteotomy under robotic guidance at the point that the surgeon selects on the patient's anatomy. The selected point, axis, and trajectory are maintained by the robotic arm while the surgeon performs the osteotomy.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance (YomiPlan Go) | Predicate Device Performance (NGS with YomiPlan v2.0) | Freehand Surgery Performance (Varga, et al, 2020) |
|---|---|---|---|
| Precision | Upper 95% Probability with 95% Model Fit |
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