(29 days)
The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab Navigation System.
The Virage® Navigation System is comprised of nonsterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. The Virage Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software (version 2.0 and higher). The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. The Virage Navigation System is also compatible with the Zimmer Biomet Universal Power System.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Virage® Navigation System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a comprehensive clinical study in the format requested.
Here's a breakdown of the information that can be extracted or inferred from the provided text, along with what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Accuracy Met | "positional accuracy...all met the acceptance criteria when the Virage Navigation instruments were attached to the ZimVie reference arrays." |
| Usability Met | "usability...all met the acceptance criteria when the Virage Navigation instruments were attached to the ZimVie reference arrays." |
| Tolerance Analysis Met | "tolerance analysis...all met the acceptance criteria when the Virage Navigation instruments were attached to the ZimVie reference arrays." |
| Packaging Effectiveness | "packaging...evaluated to determine no risks were introduced to the system." |
| Sterilization Effectiveness | "sterilization...evaluated to determine no risks were introduced to the system." |
| Automated Cleaning Safety | "Automated cleaning instructions were reviewed and adopted by the Virage Navigation System, but no risks were introduced to the system." |
| Biocompatibility (new arrays) | "The new reference arrays are non-patient contacting and are composed of stainless-steel (array body) and aluminum (array holder), and both materials were evaluated per ISO 10993-1. Since the device materials have neither direct nor indirect contact with the body, additional biocompatibility information is not necessary." (Implies acceptance criteria met for material safety.) |
| Risk Assessment (overall) | "A risk assessment was conducted that found risks have been reduced as far as possible and concluded that the benefits associated with spine surgery and the use of the Brainlab Navigation System with the Virage® Navigation System outweigh the risks related to polyaxial screw placement." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "verification and validation activities" but does not detail the sample sizes for these tests, nor the data provenance. These are typically included in the full 510(k) submission, but not in this summary letter.
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)
This information is not provided in the document. The document mentions "usability" but doesn't specify if experts were involved in establishing ground truth for any performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided 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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device in question is a navigation system for surgical procedures, not an AI diagnostic tool that human readers would interpret. The goal is to assist surgeons, not necessarily "improve human readers." The study described is a performance assessment of the navigation system itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The studies mentioned ("positional accuracy, usability, and tolerance analysis") appear to be evaluating the device performance, which is inherently a "standalone" evaluation of its mechanical and computational capabilities. However, these are not directly comparable to "algorithm only" performance for AI diagnostic tools. The device's function is to assist in surgical navigation, which implies it is always with a human in the loop during actual use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "positional accuracy." For this, the ground truth would likely be established through precise measurements using calibrated instruments or imaging techniques to determine the true position relative to the navigated object. However, the specific method of establishing this ground truth is not detailed. For "usability," the ground truth would be user feedback and observation against predefined tasks.
8. The sample size for the training set
This information is not provided in the document. The Virage® Navigation System, as described, is a mechanical and software-based navigation tool, not an AI/ML-driven diagnostic device that typically undergoes a separate "training set" for model development. The "training" for such systems would involve software development and testing rather than data-driven machine learning model training.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of an AI/ML model, this information is not applicable as per the provided document. If there are underlying algorithms that use data to improve, those details are not present here.
In summary:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It confirms that the device met specified acceptance criteria for various performance aspects (positional accuracy, usability, tolerance analysis, packaging, sterilization, cleaning, and material biocompatibility). However, it does not provide the detailed study design, sample sizes, expert qualifications, or ground truth establishment methods typically found in a clinical study report for an AI/ML diagnostic device. The device itself is a surgical navigation system, not a diagnostic AI.
§ 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).