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Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precise locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Silony Medical's VERTICALE® navigation instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.

The VERTICALE® Navigation Instruments include awls, probes, taps, drivers and inserts. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System cleared under K171421.

All instruments are made of stainless steel per ASTM F899. The VERTICALE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided text does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission (K223649) is for VERTICALE® Navigation Instruments, which are physical surgical instruments used with a stereotactic navigation system, not an AI or algorithm-based device.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this medical device submission.

The "Performance Data" section (page 5) refers to testing performed per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This standard is for evaluating the accuracy of surgical navigation systems, and the submitter states that these data are applicable because the new instruments complement existing ones and a technical evaluation confirmed compatibility and functionality. The relevant performance for this device is its navigational accuracy and compatibility with the Medtronic StealthStation®, not an AI-driven diagnostic or prognostic capability.

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