(164 days)
The SI-BONE Trackers and Universal Pin Guide are intended to enable navigation of SI-BONE instrumentation during spinal surgical procedures that utilize Medtronic StealthStation™ Systems and Stealth™ Technology. The SI-BONE Trackers and Universal Pin Guide 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, finages, or digitized landmarks for the anatomy.
SI-BONE's Navigation Tracking Instruments ("Trackers") consist of fixed and rotating elements and a pin guide. The Trackers are reusable and made from aluminum and stainless steel. The Trackers have fixed elements (posts) that support connection with reflective spheres. The Trackers can be securely attached to instruments used to place SI-BONE's implants during surgical procedures. SI-BONE's Fixed Trackers replicate the function of the Medtronic TeraTrackers. SI-BONE's Rotating Trackers replicate the function of Medtronic NavLock Trackers. SI-BONE's Universal Pin Guide replicates the function of the Medtronic Universal Drill Guide. An additional instrument is included with Fixed Trackers to allow the attachment and removal of the Fixed Trackers from the navigated instrument mounts.
This document describes the SI-BONE Navigation Tracking Instruments, which include Trackers and a Universal Pin Guide. These instruments are designed to facilitate navigation of SI-BONE instrumentation during spinal surgical procedures using Medtronic StealthStation™ Systems and Stealth™ Technology.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a tabular format for each test. Instead, it states that "All product specifications were met" for positional testing and that biocompatibility and dimensional verification were assessed.
| Test Type | Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 requirements and have identical raw materials/manufacturing to predicates. | Not required due to identical materials/processes as predicates. If required, implicitly met by this justification. |
| Positional Testing | Meet "all product specifications" for registration, display, and positional accuracy. | "All product specifications were met." |
| Dimensional Verification | Demonstrate "substantially equivalent geometry that is critical to navigation accuracy" compared to predicate devices. | A "one-to-one dimensional comparison was conducted to demonstrate substantially equivalent geometry." |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the sample size used for the positional testing or dimensional verification. It simply states that testing "underwent and passed testing" and a "one-to-one dimensional comparison was conducted."
- There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature) as these are performance tests of the physical device, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable to the type of testing described. The tests performed (biocompatibility, positional accuracy, dimensional verification) are engineering and performance validation tests of the physical device, not studies requiring expert interpretation of medical images or clinical outcomes to establish a "ground truth." The ground truth for positional accuracy would typically be established by precise metrology instruments following a standardized protocol (like ASTM F2554-2018).
4. Adjudication Method for the Test Set:
- This information is not applicable for the reasons stated above. Adjudication methods (like 2+1, 3+1) are used in studies where human reviewers or experts are assessing cases to establish a consensus ground truth, which is not the nature of the described performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not conducted or described. The document focuses on the technical performance of the navigation tracking instruments themselves, not their impact on human reader performance or diagnostic accuracy.
- Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. This device is an instrument for surgical navigation, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The device described is a physical instrument (Navigation Tracking Instruments). It is not an algorithm or software that would have a "standalone" performance in the sense of a diagnostic AI without human interaction. Its performance is intrinsically linked to its interaction with the Medtronic StealthStation™ Systems (which include hardware, software, tracking algorithms). The "positional testing" could be considered an assessment of the system's performance with the new instruments, which includes the algorithm's ability to track them.
7. The Type of Ground Truth Used:
- Biocompatibility: Ground truth is established by standardized testing protocols (ISO 10993-1) or by demonstrating equivalence to materials and processes of previously cleared, biocompatible devices.
- Positional Testing: Ground truth is established by the specified guidance in ASTM F2554-2018 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. This standard dictates methodologies for precisely measuring and verifying the accuracy of such systems, likely involving highly accurate reference measurements.
- Dimensional Verification: Ground truth is established by precise metrological measurements of the device's geometry and direct comparison to the dimensions of the predicate devices.
8. The Sample Size for the Training Set:
- This information is not applicable. The SI-BONE Navigation Tracking Instruments are physical devices, not an AI/machine learning model that undergoes "training." The testing performed validates the device's physical and functional specifications.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no "training set" for physical instruments.
§ 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).