(126 days)
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.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.