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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.

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The Navitrack® System – OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Identically as in the predicates, the Navitrack System - OS Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicates are to incorporate a new set of instruments with universal implant instrument interface features along with corresponding software changes such that the application can be compatible to track a variety of TKR implant lines.

The provided text describes the Navitrack® System - OS Knee Universal and its substantial equivalence to predicate devices, but it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

The document states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicates." However, it does not provide the results of these tests, the specific metrics used, or the thresholds for "adequate" performance.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified.
• Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable as the document does not describe a clinical study with expert ground truth establishment. The "non-clinical tests" likely refer to bench testing or simulation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable.

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

• No MRMC study was described. The device is a navigation system, not an AI diagnostic tool for human readers.

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

• The document mentions "non-clinical tests" to verify accuracy and performance "adequate for its intended use and not reduced in comparison to the predicates." This implies standalone testing of the system's accuracy, but no details of the test or results are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not specified. For non-clinical tests of a navigation system, ground truth would likely involve highly precise measurement instruments (e.g., coordinate measuring machines, optical tracking systems with known accuracy) to establish the true position/orientation of anatomical landmarks or instruments.

8. The sample size for the training set

• The document does not describe a machine learning model that would require a "training set" in the typical sense. This device is a computer-assisted surgical navigation system based on established principles of optical tracking and anatomical landmark registration, not a deep learning model requiring vast training data.

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

• Not applicable.

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The Navitrack® System -- S&N Image Free Knee is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.

It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Identically as in the predicate, the Navitrack® System - S&N Image Free Knee device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicate are to incorporate a new set of instruments to be tracked corresponding to assisting the placement of two new TKR implant lines.

The provided text is a 510(k) summary for the Navitrack® System - S&N Image Free Knee. While it describes the device and its intended use, it does not contain the detailed information required to fill out the table of acceptance criteria, device performance, and study specifics.

The summary explicitly states:
"Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate."

This statement indicates that performance data and tests were conducted, but the results of these tests, specific acceptance criteria, sample sizes, expert qualifications, and other requested details are not included in this document. The document primarily focuses on establishing substantial equivalence to a predicate device based on unchanged fundamental technology, intended use, indications, and operating principles, with modifications mainly for new instrument integration and software enhancements.

Therefore, I cannot generate the requested table and answer the specific questions based solely on the provided text. The document is a summary for regulatory submission, not a detailed study report.

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