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Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or nonnavigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used with Midas Rex [ 2 attachments and tools.

The Anteralign™ LS Navigated Reusable Surgical Instruments are spine preparation instruments made of high-grade stainless steel. The subject navigated instruments consist of existing navigated trials and a navigated interbody inserter, which were recently cleared in K221180, S.E. 5/25/22 for use in Anteralign Interbody System procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System. Per this 510(k) submission, Medtronic is seeking clearance of the navigated instruments to also be compatible with the MAZOR X™ Stealth Edition. The instruments are compatible with NavLock trackers and Medtronic single -use sterile spheres to allow the Medtronic computer-assisted surgery system, such as the Stealth Station System and MAZOR X™ System (Stealth™ Edition), to track the instruments in the surgical field.

The Medtronic Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments with MAZOR X™ (Stealth™ Edition) is a Class II Stereotaxic Instrument (21 CFR 882.4560). The 510(k) submission (K222383) is for clearance of new navigated instruments to be compatible with the MAZOR X™ Stealth Edition.

1. Table of Acceptance Criteria and Reported Device Performance:

The submission leverages performance data from a previously cleared predicate device (Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments Compatible with MAZOR X™ system (Stealth™ Edition) (K214011)). The acceptance criteria and performance are not explicitly detailed in quantitative terms for the specific subject device in these documents, but the submission states that "the subject instruments do not represent a new worst-case and the testing previously performed for the predicate devices is deemed applicable for the subject devices as there are no changes to the methods in which these instruments are used within the procedure."

Therefore, the acceptance criteria and performance are inferred from the types of tests conducted on the predicate device.

2. Sample Size for the Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set used for the subject device. Instead, it relies on performance data from a predicate device (K214011). The specifics of the sample size and data provenance (e.g., country of origin, retrospective or prospective) for the predicate device's testing are not provided in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the given documents. The tests appear to be performance engineering tests rather than clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the "Performance Data" described (Navigation Accuracy Analysis, Anatomical Simulated Use, Navigated Simulated Use), it's highly probable that these are engineering verification tests against predefined specifications, rather than clinical studies requiring adjudication of results by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not conducted or described in the provided documents. The submission focuses on substantial equivalence based on engineering performance and functional compatibility, not on assessing the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

The device is a system of navigated surgical instruments that are used with the MAZOR X™ Stealth™ Edition system. This is an assistive technology for surgeons, meaning it is inherently designed for "human-in-the-loop" performance. Therefore, a standalone (algorithm only) performance assessment would not be applicable or relevant for this type of device. The "Navigation Accuracy Analysis" and "Navigated Simulated Use" would assess the accuracy and functionality of the system, including the software algorithms, in a simulated environment, but always in the context of guiding human interaction.

7. Type of Ground Truth Used:

The ground truth used for the tests (Navigation Accuracy Analysis, Anatomical Simulated Use, Navigated Simulated Use) is implicitly derived from engineering specifications, physical measurements, and expected functional outcomes in simulated environments. It does not involve expert consensus, pathology, or outcomes data from human patients as these are pre-market device verification tests. For "Navigation Accuracy Analysis," the ground truth would be the known, precise physical location or measurement that the navigated instrument is intended to reflect. For "Simulated Use" tests, the ground truth would be the successful completion of a task or achievement of a specific functional outcome as defined by the device's design specifications.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The device consists of physical surgical instruments and compatibility with an existing navigation system. It is not an AI/ML-driven device in the sense of requiring a "training set" for model development. The performance data discussed relates to the physical and functional characteristics of the instruments.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not provided as there is no mention of a "training set" for this device.

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