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The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the MAZOR X Stealth™ Edition system. The NavLock™ Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system.

The NavLock trackers are compatible with the MAZOR X Stealth™ Edition system. The NavLock Trackers 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 subject NavLock Trackers have posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera as a means of tracking the position of the attached surgical instrument.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system. The Robotic Reference Frame has posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera for tracking location during navigated procedures.

Unfortunately, the provided text does not contain the specific details required to answer all parts of your request. It's a 510(k) summary for a medical device (NavLock Trackers and Robotic Reference Frame) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed study report with all the acceptance criteria, sample sizes, and ground truth establishment methods for a performance study of an AI/algorithm-based device.

Here's an breakdown of what can and cannot be extracted from the text:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size for the test set: Not provided. The document states "Testing conducted" and refers to "the subject devices" satisfying requirements, but gives no indication of the number of devices, patients, or data points used in the Navigational Accuracy Analysis or Accelerated Life Functionality tests.
• Data provenance: Not provided. The document does not mention the origin of any data, whether prospective or retrospective, or country of origin.

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):

• Not applicable / Not provided. These tests appear to be primarily engineering performance tests (navigational accuracy, durability) for hardware components, not a study evaluating an AI/algorithm's diagnostic or predictive performance against human experts. Therefore, there's no mention of experts establishing a "ground truth" for a test set in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not provided. Similar to point 3, this type of adjudication is typically for clinical or diagnostic studies involving human interpretation or consensus, which is not described here.

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. The document does not describe an MRMC study. The devices (NavLock Trackers and Robotic Reference Frame) are accessories for a navigation system (MAZOR X Stealth™ Edition system) and are for hardware tracking, not AI-driven image analysis or decision support that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not explicitly applicable in the AI sense. The devices themselves are hardware (trackers) that enable optical navigation. While the system (MAZOR X Stealth™ Edition) might involve algorithms, this document is about the physical accessories. The performance tests described (navigational accuracy, functionality) are "standalone" in the sense that they test the device's intrinsic mechanical/optical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the "Navigational Accuracy Analysis," the ground truth would likely be established through precise metrology equipment or other highly accurate measurement systems, rather than expert consensus or pathology, as it's a measure of physical tracking accuracy. However, the specific method is not detailed.
• For "Accelerated Life Functionality," the ground truth is simply continued functionality and integrity of the device under stress, measured against engineering specifications.

8. The sample size for the training set:

• Not applicable / Not provided. Since this document describes hardware accessories for a navigation system and not an AI or algorithm-based device that undergoes machine learning training, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable / Not provided. (See point 8).

In summary:

This 510(k) summary provides a high-level overview of performance testing for medical device accessories. It confirms that the devices met "necessary navigational accuracy requirements" and maintained "functionality throughout its intended useful life" after reprocessing. However, it lacks the granular detail (specific numerical acceptance criteria, exact performance metrics, sample sizes, detailed ground truth methods, and expert involvement) that would be present in a comprehensive study report, especially one for an AI or algorithm-driven device. The focus here is on demonstrating equivalence to an existing predicate device rather than presenting a detailed clinical or AI algorithm validation study.

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