(63 days)
The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation system. The NavLock™ Trackers should only be used with Medtronic instruments.
The NavLock Trackers are compatible with the StealthStation Systems 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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Medtronic NavLock Trackers:
The provided text (K171267) is a 510(k) summary for the Medtronic NavLock Trackers. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific new acceptance criteria through novel performance studies.
Therefore, much of the requested information about direct acceptance criteria and a new study proving it is not present in the document, as the submission relies on the prior clearance of the predicate device.
Acceptance Criteria and Study Information for Medtronic NavLock Trackers (K171267)
1. Table of Acceptance Criteria and Reported Device Performance:
The document states, "There have been no significant design changes to the NavLock Trackers since K124004. As such performance testing is not needed to demonstrate substantial equivalence in the current submission." This indicates that the device's performance is asserted to be equivalent to the predicate (Medtronic Navigated Taps and Screwdrivers - K124004) and therefore implicitly meets the predicate's acceptance criteria.
The table below summarizes the types of performance testing conducted previously (to support K124004 and compatible instrumentation), but specific numerical acceptance criteria and reported performance values for those tests are not provided in this 510(k) summary.
| Acceptance Criteria Category | Reported Device Performance (as implied by substantial equivalence to K124004) |
|---|---|
| Navigation Accuracy | Verified 2D and 3D navigational accuracy to meet requirements (specific values not provided in this document). |
| Anatomical Simulated Use | Validated that the product appropriately satisfies user needs through simulated surgical technique. |
| Navigation Simulated Use | Demonstrated that navigation-specific procedural steps can be executed for spinal procedures. |
| CAD Model Evaluation | Confirmed instrument CAD models accurately reflect physical instrument in software. |
| Implant/Instrument Mating Conditions | Verified design requirements for assembly, fit, and function with implant systems (for instruments that navigate implant placement). |
| Software/Instrument Integration | Confirmed required interface needs with spine application software (installation, system configuration, tool verification, functionality). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in this document. The document states that no new performance testing was conducted for this submission because there were no significant design changes. The listed tests were conducted to support the original K124004 and compatible instrumentation.
- Data Provenance: Not specified for the historical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified. This information would typically be detailed in the original studies for the predicate device (K124004) or compatible instrumentation, not in this substantial equivalence submission where new testing was deemed unnecessary.
4. Adjudication Method for the Test Set:
- Not specified.
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 was not done. The device (NavLock Trackers) is a physical surgical instrument accessory for navigation, not an AI or imaging diagnostic device that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The NavLock Trackers are physical components for a surgical navigation system and do not involve a standalone algorithm in the manner typically described for AI/software devices. The "algorithm" is part of the overall StealthStation surgical navigation system, and the trackers provide input for that system.
7. The Type of Ground Truth Used:
- For the performance tests listed (e.g., Navigation Accuracy, Anatomical Simulated Use), the ground truth would likely have been established through:
- Metrology/Calibration Standards: For navigation accuracy.
- Expert Observation/Assessment: For simulated use tests, where surgical experts or trained personnel would evaluate task completion and performance against established protocols.
- Design Specifications: For CAD model evaluation and mating conditions.
- The specific method of establishing ground truth is not detailed in this 510(k) summary.
8. The Sample Size for the Training Set:
- Not applicable / Not specified. As this is a physical device accessory for a navigation system, traditional "training sets" as understood in machine learning/AI models are not relevant. Any "training" would refer to internal validation data for the navigation system's software, which is not detailed here.
9. How the Ground Truth for the Training Set was Established:
- Not applicable / Not specified for the reasons mentioned in 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).