Search Results

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:

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device