(30 days)
The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with Medtronic systems utilizing STEALTH™ Technology. The NavLock™ Trackers should only be used with Medtronic instruments on Medtronic systems utilizing STEALTH™ Technology.
The NavLock™ Trackers are compatible with StealthStation™ Systems and Mazor X STEALTH™ Edition and are used in conjunction with various navigated spine instrumentation for optical navigation. To enable navigation compatibility, the proximal ends of the instruments are designed to fit into the NavLock™ Trackers for optical navigation. The NavLock™ Trackers have posts to affix reflective spheres, which are visible to the StealthStation camera as a means of tracking the position of the attached surgical instrument.
The provided text describes a 510(k) premarket notification for Medtronic Navigation's NavLock Trackers. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel study to determine acceptance criteria and device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable or not provided in the given document.
However, based on the information available, here's a reconstructed answer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Error ≤ 2.0 mm | ≤ 2.0 mm positional error |
| Trajectory Error ≤ 2.0° | ≤ 2.0° trajectory error |
| Substantial Equivalence to predicate devices | Demonstrated through comparison to K182104 and K171267 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in the provided text for the current submission (K201327). The document indicates "worst-case test configurations" were used in previous clearances (K182104 and K171267).
- Data Provenance: The document does not specify the country of origin. The previous studies were "system-level accuracy testing." It's retrospective in the sense that the current submission relies on previous clearances and states "There have been no significant design changes to the NavLock™ Trackers since clearance in K182104. Therefore, performance testing is not needed to demonstrate substantial equivalence in the current submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The performance testing was for device accuracy (positional and trajectory error), which typically relies on metrological measurements rather than expert human interpretation to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this device's accuracy testing.
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:
- Not applicable. This is a medical device (trackers for navigation systems), not an AI diagnostic algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance testing cited (positional and trajectory error) represents the "standalone" accuracy of the navigation system when using the trackers. The device itself (NavLock Trackers) is a component of a navigation system, and its performance contributes to the overall system's accuracy. The stated accuracies (≤2.0 mm positional error and ≤2.0° trajectory error) can be considered the standalone performance based on the system's measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the accuracy testing, the ground truth would have been established by precise measurement systems (e.g., optical metrology systems) used to determine the true position and trajectory, against which the device's measurements were compared. The text mentions "system level accuracy testing."
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on its physical design and optical tracking principles.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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).