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Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon 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 any medical condition 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 non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Gide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Mectronic Surgical Instruments are also compatible with the UC'M 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 Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ System, 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 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. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.

The Navigated Anterolateral Disc Prep Instruments are made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The instruments are compatible with Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system such as the StealthStation™ System or MAZOR X Stealth™ Edition System to track the instruments in the surgical field.

The document provided does not describe an AI/ML device, and therefore does not contain information about acceptance criteria or supporting studies that would typically apply to such devices (e.g., sample sizes for test sets, data provenance, ground truth establishment, MRMC studies, or standalone performance).

The device in question, "Navigated Anterolateral Disc Prep Instruments," is a surgical instrument used with navigation systems (StealthStation™ System and MAZOR X Stealth™ Edition) to assist surgeons in precisely locating anatomical structures during spinal surgery. The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on identical intended use, fundamental scientific technology, materials, sterilization method, and compatibility.

While "Performance Testing" is mentioned (Section VII), this refers to traditional medical device validation for functionality and compatibility, not AI/ML model performance. The tests include:

• Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
• CAD Model Verification: Confirmed CAD models are accurately reflected in the application software.
• Tools Package Functional Verification: Confirms that the Spine tools package met required interface needs of the spine application software.
• NAV Simulated Use: No new testing completed.
• Anatomical Simulated Use: No new testing completed.

The document indicates that the "Navigated Anterolateral Disc Prep Instruments were previously cleared within (K192336, S.E. 11/22/2019) and are not undergoing any design changes." The current submission (K211441) primarily seeks additional use with the MAZOR X Stealth™ Edition System, extending compatibility from the StealthStation™ System.

Therefore, the requested information about acceptance criteria for an AI/ML device, associated study details, and ground truth establishment is not applicable to this submission.

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