(115 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 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.
§ 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.