Search Results

The Yomi Robotic System (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. 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. 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.

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: Integrating algorithms that provide automatic segmentation of maxillary sinuses, inferior alveolar nerve, and maxillary and mandibular bone. The integrated software, Relu Creator, was cleared in K233925. The software is not adaptive, it is trained at the manufacturer (Relu), and the weights are locked.

Additionally, since the most recent clearance of Yomi Robotic System (K231018), minor modifications to the Yomi System include the following:
• Planning software improvements
• Restorative planning – Features to support customized crown design
• Dual arch planning – Feature to enable the end user to plan multiple arches in a singe case and a singe scan
• Patient work volume guidance improvements – Added guidance for the angulation of the patient chair
• Added patient proximity for baseline
• YomiLink Bone (YLB) planning – improved placement of the YLB
• Added proximity threshold lower limit value
• Improved alignment between CT scans and imported .stl objects
• Added ability for user to designate soft tissue thickness to assist in bone reduction planning
• Added max depth information to the implant cursor hover info
• VTK Off-the-Shelf software version update
• Added model details to implant selection
• Added restorative planning case feedback option
• Added additional implant models to the implant library

• Control software and behavior improvements
• Updates to handpiece interaction gestures, and optimization of the response of the control software to guide arm joint limits, singularities and potential wrist / base collisions.

• Hardware improvements Tracker Arm Joint

• Accessory improvements
• Updates to the YomiLink Teeth and intraoral fiducial array

• Minor bug fixes

All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

The provided FDA 510(k) clearance letter for the Yomi Robotic System focuses on the substantial equivalence of the modified device to its predicate. While it mentions the integration of an automatic segmentation algorithm (Relu Creator, K233925), it does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria for the automatic segmentation algorithm.

The document primarily describes:

• The indications for use.
• A comparison of technological characteristics between the subject device (Yomi Robotic System with Automatic Segmentation Algorithm) and its predicate (Yomi Robotic System K231018) and a reference device (Relu Creator K233925).
• General statements about software, cybersecurity, and usability verification and validation testing, but without specific performance metrics or study details.

Therefore, many of the requested details about acceptance criteria, specific performance results, sample sizes, expert qualifications, and ground truth establishment for the automatic segmentation algorithm are not present in the provided text. The document refers to the Relu Creator (K233925) as having been cleared, implying its own performance evaluations would have been submitted in that separate clearance.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided for the automatic segmentation algorithm (Relu Creator) in this document. The document states:

• "Yomi Plan 2.7 with Automatic Segmentation Algorithm functionality was successfully verified and user validated."
• "The software has been successfully verified to perform with the PC specifications of the Yomi Robotic System."
• "All changes have been successfully verified and, therefore, not considered to affect the overall safety and efficacy profile of Yomi Plan."
• "The combined testing and analysis of results provides assurance that the device performs as intended."

These are general assurances of performance and validation but do not provide specific quantitative acceptance criteria or reported device performance metrics for the automatic segmentation algorithm itself.

2. Sample size used for the test set and the data provenance

Not provided in this document. The document mentions "Software verification and validation testing" and "User Validation testing" but does not specify the sample size of cases or the provenance (country of origin, retrospective/prospective) of the data used for testing the automatic segmentation algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided in this document.

4. Adjudication method for the test set

Not provided in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not provided in this document. The document does not mention an MRMC study or any results comparing human reader performance with and without AI assistance from the segmentation algorithm. The automatic segmentation algorithm is integrated into the planning software to assist (presumably by providing pre-segmented anatomy), but its impact on human reader performance is not quantified here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not explicitly detailed for the segmentation algorithm's performance. The document states, "The integrated software, Relu Creator, was cleared in K233925." This implies that the Relu Creator, which performs the automatic segmentation, underwent its own standalone performance evaluation as part of its original clearance (K233925). This current 510(k) focuses on its integration into the Yomi Robotic System, not its primary standalone performance evaluation.

7. The type of ground truth used

Not explicitly provided in this document for the automatic segmentation algorithm. For image segmentation algorithms, ground truth is typically established through manual segmentation by experts, often on a pixel/voxel level, sometimes validated by pathology or clinical outcomes. The document does not specify which method was used for the Relu Creator.

8. The sample size for the training set

Not provided in this document. The document states, "The software is not adaptive, it is trained at the manufacturer (Relu), and the weights are locked." This confirms that training occurred, but the size of the training dataset is not mentioned.

9. How the ground truth for the training set was established

Not provided in this document. Similar to item 7, the method for establishing ground truth for the training data is not detailed.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 44 implants placed in 15 patient arches.
• Data Provenance: Prospective, multi-center, single-arm study (G210363) involving partially or fully edentulous patients. The study was conducted clinically with actual patients. The specific country of origin is not explicitly stated, but the submission is to the US FDA, implying it would be relevant to US practice.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Number of Experts:
  • 3 investigators (general dentists) who performed the procedures.
  • 1 independent 3rd party oral surgeon who performed an independent clinical assessment of all 15 cases.
• Qualifications of Experts:
  • Investigators: General dentists.
  • Independent Assessor: 3rd party oral surgeon. Specific years of experience are not mentioned for any of the experts.

4. Adjudication Method for the Test Set:

• The text describes case-by-case feedback from investigators (through CRF feedback) and an independent 3rd party clinical review of all 15 cases. This suggests a form of independent review rather than a strict 2+1 or 3+1 consensus process among multiple readers for ground truth establishment. Agreement between these groups (investigators' safety feedback, 3rd party review), especially regarding "no vital anatomical structure concerns," served as a form of "ground truth" for clinical safety and acceptability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• No, an MRMC comparative effectiveness study was not explicitly stated to have been done in the traditional sense of evaluating human readers with and without AI assistance.
• The study primarily focused on the standalone performance of "YomiPlan Go" relative to freehand techniques and comparison metrics with the predicate device. The "human factors" evaluation was for the new YomiPlan Go workflow itself by the operating surgeons, not a comparison of human interpretation/performance with and without AI.
• The benefits assessment does highlight how YomiPlan Go assists surgeons (e.g., depth stop, prevention of skiving, parallelism, precision in repeated drilling), which could be interpreted as improving human performance, but this wasn't quantified through an MRMC study design measuring specific effect sizes of human improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

• Yes, in part, a standalone assessment of the algorithmic component's performance (precision, depth, and lateral error) was conducted as a secondary objective of the clinical study, comparing pre-operative plans (ideal locations) to post-operative implant placement.
• The system's precision specification (Upper 95% Probability with 95% Model Fit < 1.00 mm) is also mentioned as supported by benchtop verification testing, which would typically be a standalone performance test. However, the accuracy is explicitly stated as "N/A for YomiPlan Go" as it's not a specification for this specific mode, which relies on the surgeon's real-time visual assessment rather than a pre-loaded CT.

7. The Type of Ground Truth Used:

• The ground truth for the performance metrics (depth, lateral, and angular error) was established by comparing preoperative clinical plans (ideal planned implant locations on CBCT scans) with postoperative CBCT scans capturing the actual placement of implants.
• For clinical safety and acceptability, the ground truth was based on the assessment and feedback from the investigators and an independent 3rd party oral surgeon, specifically their confirmation of "no vital anatomical structure concerns."

8. The Sample Size for the Training Set:

• The document does not provide information on the sample size for the training set for the Yomi or YomiPlan Go system. The focus of this submission is on the clinical validation of a new feature (YomiPlan Go) for a previously cleared device.

9. How the Ground Truth for the Training Set Was Established:

• The document does not provide information on how the ground truth for the training set was established. Since the details of the training set size or methodology are not given, the ground truth establishment method for it is also absent.

Ask a specific question about this device