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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

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.

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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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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.

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.

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