(28 days)
The Vital Navigation System instruments are used during the preparation and placement of the Vital vy System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System.
The Vital™ Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. Both combinations are used 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. The use of these navigation systems provides the surgeon access to real-time multi-plane 3D images) providing confirmation of hardware placement.
The provided text states that the Vital™ Navigation System underwent performance testing, including positional accuracy, usability, and tolerance analysis, and that all met the acceptance criteria when the Vital Navigation instruments were attached to the ZimVie reference arrays.
However, the document does not provide a specific table of acceptance criteria or the reported device performance values for these tests. It also does not detail the study design elements like sample sizes, data provenance, expert qualifications, or the use of MRMC studies.
Therefore, for aspects not explicitly stated in the document, I will indicate "Not specified in the document."
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional accuracy | "met the acceptance criteria" |
| Usability | "met the acceptance criteria" |
| Tolerance analysis | "met the acceptance criteria" |
Note: The document states that these tests were performed and met the criteria, but the specific metrics or values for the acceptance criteria and the performance are not provided.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the document.
- Data provenance (country of origin, retrospective/prospective): Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the document. The testing described (positional accuracy, usability, tolerance analysis) seems to be related to the device's technical specifications rather than the generation of clinical ground truth by experts for classification tasks.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the document.
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, an MRMC comparative effectiveness study is not mentioned as having been performed. The device is a "Stereotaxic Instrument" and "Navigation System," which aids surgeons in locating anatomical structures and placing screws. It is not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is a "Navigation System" used with human surgeons. It's an instrument assisting a human operator, not a standalone algorithm making autonomous decisions or interpretations that would have an "algorithm only" performance metric in the traditional sense of AI diagnostics. The "positional accuracy" testing would be the closest analogue to a standalone performance metric for a navigation system, indicating its inherent precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The nature of the "ground truth" for a navigation system's performance would primarily be related to its engineering precision and accuracy (e.g., actual vs. measured positions, successful and precise placement in simulated or cadaveric models during testing). The document refers to "positional accuracy," "usability," and "tolerance analysis," which imply engineering and usability testing rather than a clinical ground truth established by medical outcomes or expert consensus on a diagnosis.
8. The sample size for the training set:
- Not applicable/Not specified. This device is not described as an AI/ML-based system that undergoes a "training" phase with a dataset. Its performance is validated through engineering and usability testing.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, this device does not appear to be an AI/ML-based system with a training phase.
§ 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).