(158 days)
Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The provided document is a 510(k) clearance letter for the Zimmer Biomet Vital Navigation System. It primarily outlines the regulatory approval for a medical device and its intended use, rather than detailing a study focused on the performance of an AI/algorithm against acceptance criteria.
The document discusses "accuracy testing of the stereotactic instruments" and cites ASTM F2554-18, which is a standard practice for measuring positional accuracy of computer-assisted surgical systems. This testing is for the hardware (instruments used in conjunction with the Medtronic StealthStation System), not an AI or algorithmic component that would require a study with human readers or AI-specific performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth for training sets, are not applicable or not present in this regulatory clearance letter because the device is a set of physical surgical instruments, not an AI or software algorithm.
Here's a breakdown of the relevant information that can be extracted, and where the document is silent on AI/algorithmic performance:
Device: Vital Navigation System (non-sterile, reusable instruments: awls, probes, taps, drivers)
Function: To be used with the Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures for placement of Vital and Vitality screws during spinal surgery.
1. A table of acceptance criteria and the reported device performance
Based on the document, the device's performance is tied to "accuracy testing" of its stereotactic instruments. The acceptance criteria are implicitly that the device "functioned as intended" and "demonstrated substantial equivalence" to predicate devices, particularly regarding positional accuracy. Specific numerical acceptance criteria for accuracy are not provided in this summary document, nor are specific numerical results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Accuracy (per ASTM F2554-18 - details not specified in document) | "In all instances, the proposed instrument system functioned as intended and demonstrated substantial equivalence to the predicate device(s)." |
| Safety and Effectiveness | "The assessment concluded that the use of the proposed stereotactic instruments for the implantation of Vital and Vitality screws are safe and effective for use." |
Note: This is an approval for physical instruments, not an AI system. The "performance" refers to the mechanical and operational accuracy of the instruments, not an algorithm's diagnostic or predictive capabilities.
2. Sample sized used for the test set and the data provenance
- Not Applicable/Not Provided for AI study. The document only mentions "accuracy testing" of the instruments per ASTM standards. It does not disclose the sample size (e.g., number of tests, number of cases/patients) or data provenance (e.g., country of origin, retrospective/prospective nature) for the engineering verification testing. This information would typically be detailed in the test reports, which are not part of the 510(k) summary provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This information is relevant for studies involving human interpretation or AI performance where expert ground truth is established. The device discussed here is a set of surgical instruments evaluated for mechanical/positional accuracy, not for diagnostic performance requiring expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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. This is a hardware device (surgical instruments), not an AI assistance system for human readers. Therefore, an MRMC comparative effectiveness study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The device is a set of surgical instruments; there is no standalone algorithm. Its function is to assist in real-time surgical navigation when used with the Medtronic StealthStation System.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering/Physical Measurement: For the "accuracy testing" of the stereotactic instruments, the ground truth would have been established through precise engineering measurements of positional accuracy, likely using calibrated tools and fixtures as prescribed by ASTM F2554-18. It would not involve expert consensus on medical images or pathology.
8. The sample size for the training set
- Not Applicable. This device did not involve machine learning or a "training set" in the context of an AI algorithm. Its performance is based on its mechanical design and precise manufacturing.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).